Virtual Clinical Trial
Clinical Research Remote Summary
Fig 1.1 Virtual clinical trials
Traditional clinical trials, the backbone of medical progress, have long relied on participants visiting research sites for check-ups and data collection. But what if there was a way to participate in groundbreaking research from the comfort of your own home? Enter virtual clinical trials, revolutionizing how medications and treatments are developed in the USA.
What are Virtual Clinical Trials?
Virtual clinical trials, also known as decentralized trials or remote trials, leverage technology to conduct research remotely. Participants use web portals, mobile apps, wearable devices, and telemedicine to complete study visits and share data electronically. This innovative approach breaks down geographical barriers, making participation more accessible than ever before. For those coordinating these trials, the Clinical Research Coordinator course is an excellent resource.
Benefits of Virtual Clinical Trials in the USA
Convenience: Participate in research from the comfort of your home, eliminating travel burdens and time constraints.
Increased Accessibility: Reach a wider pool of participants, including those in rural areas or with mobility limitations.
Real-World Data: Collect data in participants' natural environments, providing a more accurate picture of treatment effectiveness.
Improved Engagement: Empower participants to track their health data and stay actively involved in the research process. For those interested in a deeper understanding or pursuing a career in this field, consider exploring the Clinical Trials Assistant Training course.
A New Era of Data Collection
Virtual clinical trials introduce a revolutionary method for collecting safety and efficacy data throughout the entire research process, from study start-up to execution. This approach leverages technology and online social engagement platforms to prioritize patient comfort during each stage. Professionals looking to enhance their expertise in this innovative method might find the Advanced Clinical Research Project Manager Certification beneficial.
The Impact of COVID-19
The COVID-19 pandemic rapidly challenged the pharmaceutical industry to adopt remote clinical research methods. While the industry previously lacked extensive experience with this approach, the pandemic highlighted the immense potential of virtual trials. As a result, the industry is making significant strides in embracing this operational paradigm. Those involved in overseeing trials might benefit from the Medical Monitor Certification and those involved in conducting the research may find the CRA (Clinical Research Associate) training crucial for their role.
Remote Data Collection: Advantages and Considerations
It's important to acknowledge that remote data collection won't be feasible for all types of measurements. To ensure its effectiveness, researchers will need to define a decision tree to identify which clinical measures can be translated into reliable remote measurements.
Even when remote data collection is possible, several crucial activities are required to guarantee the safety, usability, and validity of the collected data. These activities include establishing a measurement frequency, scheduling assessments for remote measurements, and addressing the continuous data recording capabilities of many connected devices. For those looking to further specialize in data integrity and safety in remote trials, the Pharmacovigilance Certification provides comprehensive training. Moreover, for physicians aiming to become principal investigators in such innovative trials, the Advanced Principal Investigator Physician Certification is designed to prepare them extensively.
The Balancing Act: Remote vs. Traditional Assessments
Collecting clinical trial data remotely presents both advantages and disadvantages. While it offers increased convenience and accessibility, it may not be suitable for all types of measurements. Recognizing these limitations and implementing robust data collection practices are essential for ensuring the success of virtual clinical trials.
Is a Virtual Clinical Trial Right for You?
If you're interested in contributing to medical advancements and potentially experiencing the latest treatments, virtual clinical trials could be a perfect fit. However, it's crucial to understand that eligibility requirements vary depending on the specific study.
Finding Virtual Clinical Trials in the USA
Numerous resources can help you find virtual clinical trials in the USA:
ClinicalTrials.gov: A comprehensive database of federally funded clinical trials, including virtual ones.
Patient advocacy groups: Many organizations connect patients with research opportunities related to their specific conditions.
Telehealth platforms: Some platforms connect patients with virtual trials focused on various health areas.
The Future of Virtual Clinical Trials
As technology continues to evolve, virtual clinical trials are poised to play an even greater role in shaping the future of healthcare research in the USA. They offer a more efficient, inclusive, and patient-centric approach to developing life-saving treatments.
Considering participating in a virtual clinical trial? Explore the resources listed above and discuss your options with your healthcare provider. You can be a part of groundbreaking research and contribute to a healthier future for all.
Fig 1.2 Decision tree for identification and implementation of remote measurement
FDA guidance on remote monitoring
FDA plays a crucial role in protecting the united states from threats such as emerging infections including pandemics such as coronavirus. FDA is issuing this guidance to provide general consideration to assist sponsors in assuring the safety of participants, maintains compliance, and minimizing risk to trial integrity. FDA guidance on the conduct of the clinical trial of the medical product during COVID-19 pandemic is important, in case to know about the drug safety or proper usage.
The progress of adopting a decentralized clinical trial model and remote data collection was limited before the COVID-19 pandemic. However, the rapid adoption of telehealth during COVID-19 when the remote doctor visits become vital. Remote monitoring clinical trials during COVID-19 become crucial. The rapid rate of adoption to remote measurements and sharing the experience and results can accelerate the field of clinical trials. During COVID-19 pandemic, many details still need to be figured out regarding remote monitoring. However, the current situation could be an opportunity to revamp the conventional clinical trial models.
Virtual clinical trials can satisfy the need for vigorous clinical trials by using distributed technologies. Virtual clinical trials can reduce cost, shorten trial timelines, increase protocol adherence, and boost recruitment members and participants diversity. These trails provide access to the participant to the research team through a technology’s web portal. Although complete development regarding the collection of a lot of data. This approach holds growth potential. It is also critical in the social component of clinical trials along with the trust that can develop between participants and researchers. A VR based communication hub for VCT should reinsert some human of elements to these studies Use of VR to support interpersonal relation between participant and researchers are important for the single-blind study.
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Fig 1.3 Virtual clinical trial monitoring
References:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency - FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/ - Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/ - Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6969384/ - A Virtual Home for the Virtual Clinical Trial
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051945/ - Conducting a Virtual Clinical Trial in HER2-Negative Breast Cancer Using a Quantitative Systems Pharmacology Model With an Epigenetic Modulator and Immune Checkpoint Inhibitors
Remote Monitoring is The Future of Clinical Research
Remote Monitoring is The Future of Clinical Research
Remote clinical trials are not new topics in clinical research. Scientists have long suggested the use of virtual or decentralized clinical trials, but the recent pandemic has pushed these ideas into the spotlight. The FDA has encouraged the use of technology, non-contact drug deliveries, and telehealth for clinical trials.
Thus, experts believe that the implementation of decentralized clinical trials has been accelerated by 1-2 years. Although some may believe that remote clinical trials will only be a temporary fix for the current situation, many professionals believe that they will reshape the future of clinical research.
In a financially unstable time, remote clinical trials have drastically reduced the cost of conducting clinical trials. By reducing the number of patient visits, companies are using less staff and these staff are working fewer hours.
The financial benefits of utilizing remote trials will likely impact future trial designs and continue to attract the attention of businesses long after the pandemic.
In addition to being less expensive, going virtual has helped trials become more efficient on every level. AI programs have been used to successfully find eligible patients for trials. For those interested in learning about the utilization of AI and improving trial efficiency, consider the Advanced Clinical Research Project Manager Certification.
Virtual clinical trials are making participation more accessible, especially those who live in rural areas and have mobility issues. By simplifying trials participation and accessibility, researchers expect a decrease in dropout rates.
Since most data are collected directly from the patient’s electronic device, researchers have been using automated programs to analyze and store patient data immediately after collection. Those looking to deepen their understanding of data management in clinical trials might explore the Clinical Research Coordinator course.
Although there have been concerns about data accuracy and security, many believe that future technology will be the solution to these problems. These improvements in efficiency have resulted in shortened timelines, which are appealing to sponsors for requiring less funding.
Due to the positive outcomes of remote clinical trials, many investors are recognizing the current and future potential of virtual clinical trials. In July 2020, Medable, a virtual clinical trials company, started working with healthcare data firm Datavant to run decentralized trials.
Additionally, PPD and Covance have also teamed up with Medable to create a better virtual clinical trial experience. Medable’s CEO and cofounder, Michelle Longmire, M.D., plans to cut clinical trial timelines by 50% by incorporating more data sources in digital trials.
One month later, in August 2020, Science 37, another virtual clinical trials company, raised $40 million to create new virtual trials technology. The company plans to focus on patient accessibility as well as simplifying the implementation of decentralized trials for CROs and pharmaceutical companies.
There is no doubt that covid 19 has altered the way clinical research is conducted and quickly creating a new field of opportunities. The incentives of using clinical research are attracting large funding from investors and steadily creating a lucrative field in clinical research.
Since decentralized and virtual clinical trials are here to stay, enterprising professionals should start to master the art of working remotely in clinical research. If you are interested in pursuing or furthering your career in clinical research, please check out our specialized training programs such as Pharmacovigilance Certification, CRA Certification, ICH-GCP Training, Clinical Trials Assistant Training, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification below to learn more about the clinical research job scene.
5 Tips and Tricks to Working from Home in Clinical Research During a Pandemic…or remotely
The COVID-19 crisis has created a new normal in the workplace. Many companies have required their employees to work remotely as much as possible, and the clinical research field is no different. In this unprecedented time, the FDA has encouraged the use of technology, telehealth, and remote drug deliveries for conducting clinical trials. For many clinical research professionals, the shift to remote work can be challenging and difficult to navigate. However, experts believe that virtual clinical trials are going to be a huge part of the field’s future. To effectively manage these trials, consider the Advanced Clinical Research Project Manager Certification. This article has compiled some of the best tips and tricks to help you plan a productive and fulfilling workday at home.
Check Out Company Guidelines
Working in a pandemic is a special circumstance that deserves special considerations from employers. What a lot of people forget is that most companies have created HR guidelines for employees working during a time of crisis. Reviewing these guidelines can help you understand your company’s remote work policies, as well as procedures and expectations. For those looking to further understand and comply with regulatory standards, consider exploring the ICH-GCP course to deepen your knowledge on international guidelines. Additionally, the role of Pharmacovigilance Certification is crucial in ensuring drug safety, which is paramount during such trials.
Enhancing Team Coordination
Effective communication is key in remote work settings, especially when coordinating clinical trials. Clinical Trials Assistants play a vital role in this, and gaining specialized skills through the Clinical Trials Assistant Training can enhance your ability to manage projects efficiently. For Clinical Research Associates (CRAs), who ensure the smooth execution of these trials, the CRA certification can provide the necessary training to adapt to the evolving landscape.
Special Roles in Clinical Research
For advanced positions such as Medical Monitors and Principal Investigators, specific certifications like the Medical Monitor Certification and the Advanced Principal Investigator Physician Certification are essential. These certifications prepare you for high-level oversight and critical decision-making roles necessary for the success of remote clinical trials.
Set physical and social boundaries
One of the chief complaints of working from home is being unable to focus. It is easy to get distracted when you are a few steps from the TV, or you are sharing the space with other people. To have a distraction-free workday, it is important to create a designated workspace that you feel comfortable working in. This way, as soon as you enter the room, your brain is ready to concentrate on the right thing.
In addition, although it is important to socialize, set boundaries with those around you to make sure that you leave the socializing to after work is over.
Get into a Routine
Even though you are working from home, it can be very helpful to a structured schedule. When creating a work routine, it is not only important to determine when you should start working, it is also important to determine when you should stop. This helps prevent burnout and allows you to focus on other important things in your life.
Get the Right Tech
When you’re in clinical research, having reliable technology is vital to many positions. For example, it is important that your computer can run the programs and softwares you need for your job. Otherwise, you might have to consider getting an upgrade before going remote. Additionally, it is important that you understand how to use virtual communication programs like Zoom, so you can connect regularly and effectively with your boss and colleagues.
Over Communicate
Out of all of the tips discussed in the article, this one is the one that most experts agree on. As you begin working remotely, you will notice very quickly that it is harder and more important than ever to connect with your colleagues and managers. It is not only helpful to update your colleagues and bosses more frequently, it is also important to keep up social habits you had before the pandemic. If you always talked to a particular colleague before the weekly meeting, try giving them a call before the same virtual meeting. This way, you’ll be able to maintain your old routine and keep up with your office even when you’re working from home.
Since the pandemic has drastically changed the way we work, here are some new ways to elevate your workday at home. As discussed in our other article, clinical research is developing a new perspective that generates new opportunities and to change the field. Virtual clinical trials (VCTs) are going to stay in the field, and the technical and self knowledge you gain working during this time will serve you well in future clinical research projects. If you want to learn more about the clinical research profession, please check out our specialized training programs and articles below to learn more about the clinical research job scene.
Learn more Work From Home Tips by Katie Holmes
COVID-19 Summary of 102 Clinical Trials
All trial information below is sourced from the clinicaltrials.gov website.
THE EFFICACY AND SAFETY OF HUAI ER IN THE ADJUVANT TREATMENT OF COVID-19
Drug: Huaier Granule
Mortality rate|Clinical status assessed according to the official guideline|The differences in oxygen intake methods|Duration (days) of supplemental oxygenation|Duration (days) of mechanical ventilation|The mean PaO2/FiO2|Length of hospital stay (days)|Length of ICU stay (days)|Pulmonary function
18 Years to 75 Years (Adult, Older Adult)
Phase 2|Phase 3
N=550
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
April 1, 2020 - September 1, 2020
https://ClinicalTrials.gov/show/NCT04291053
RECOMBINANT HUMAN ANGIOTENSIN-CONVERTING ENZYME 2 (RHACE2) AS A TREATMENT FOR PATIENTS WITH COVID-19
Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)
Time course of body temperature (fever)|Viral load over time|P/F ratio over time|Sequential organ failure assessment score(SOFA score) over time|Pulmonary Severity Index (PSI)|Image examination of chest over time|Proportion of subjects who progressed to critical illness or death|Time from first dose to conversion to normal or mild pneumonia|T-lymphocyte counts over time|C-reactive protein levels over time|Angiotensin II (Ang II) changes over time|Angiotensin 1-7 (Ang 1-7) changes over time|Angiotensin 1-5 (Ang 1-5) changes over time|Renin changes over time|Aldosterone changes over time|Angiotensin-converting enzyme (ACE) changes over time|Angiotensin-converting enzyme 2 (ACE2) changes over time|Interleukin 6 (IL-6) changes over time|Interleukin 8 (IL-8) changes over time|Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time|Plasminogen activator inhibitor type-1 (PAI-1) changes over time|Von willebrand factor (vWF) changes over time|Tumor necrosis factor-α (TNF-α) changes over time|Soluble receptor for advanced glycation end products (sRAGE) changes over time|Surfactant protein-D (SP-D) changes over time|Angiopoietin-2 changes over time|Frequency of adverse events and severe adverse events
18 Years to 80 Years (Adult, Older Adult)
Not Applicable
N=0
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 2020 - April 2020
GCP Office of The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
https://ClinicalTrials.gov/show/NCT04287686
CLINICAL TRIAL ON REGULARITY OF TCM SYNDROME AND DIFFERENTIATION TREATMENT OF COVID-19.
Drug: TCM prescriptions
The relief / disappearance rate of main symptoms|Chest CT absorption|Virus antigen negative conversion rate|Clinical effective time: the average effective time|The number of severe and critical conversion cases|Incidence of complications|Traditional Chinese Medicine Syndrome Score
18 Years to 75 Years (Adult, Older Adult)
N=340
Observational Model: Cohort|Time Perspective: Prospective
March 2, 2020-May 2020
Huai'an fourth people's Hospital, Huaian, Jiangsu, China
https://ClinicalTrials.gov/show/NCT04306497
THE COVID-19 MOBILE HEALTH STUDY (CMHS)
Other: nCapp, a cell phone-based auto-diagnosis system
Accuracy of nCapp COVID-19 risk diagnostic model
18 Years to 90 Years (Adult, Older Adult)
N=450
Observational Model: Cohort|Time Perspective: Prospective
February 14, 2020-May 31, 2020
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04275947
A PILOT STUDY OF SILDENAFIL IN COVID-19
Drug: Sildenafil citrate tablets
Rate of disease remission|Rate of entering the critical stage|Time of entering the critical stage|Rate of no fever|Rate of respiratory symptom remission|Rate of lung imaging recovery|Rate of C-reactive protein (CRP) recovery|Rate of Biochemical criterion (CK, ALT, Mb) recovery|Rate of undetectable viral RNA (continuous twice)|Time for hospitalization|Rate of adverse event
18 Years and older (Adult, Older Adult)
Phase 3
N=10
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 9, 2020-November 9, 2020
Department and Institute of Infectious Disease, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04304313
Key Clinical Trials in COVID-19 Treatment and Intervention Strategies
Relevant Courses for Understanding Clinical Trials:
This list of courses offers comprehensive training and certification opportunities for professionals interested in enhancing their understanding and skills in clinical research, particularly in navigating the complexities of COVID-19 clinical trials.
CRITICALLY ILL PATIENTS WITH COVID-19 IN HONG KONG: A MULTICENTRE OBSERVATIONAL COHORT STUDY
28 day mortality|vasopressor days|days on mechanical ventilation|sequential organ function assessment score|ECMO use|percentage nitric oxide use|percentage free from oxygen supplement
18 Years and older (Adult, Older Adult)
N=8
Observational Model: Case-Only|Time Perspective: Retrospective
February 14, 2020-February 25, 2020
Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong|Prince of Wales Hospital, Hong Kong, Hong Kong|Princess Margaret Hospital, Hong Kong, Hong Kong
https://ClinicalTrials.gov/show/NCT04285801
SAFETY AND IMMUNITY OF COVID-19 AAPC VACCINE
Biological: Pathogen-specific aAPC
Frequency of vaccine events|Frequency of serious vaccine events|Proportion of subjects with positive T cell response|28-day mortality|Duration of mechanical ventilation if applicable|Proportion of patients in each category of the 7-point scale|Proportion of patients with normalized inflammation factors|Clinical improvement based on the 7-point scale if applicable|Lower Murray lung injury score if applicable
6 Months to 80 Years (Child, Adult, Older Adult)
Phase 1
N=100
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 15, 2020-December 31, 2024
Shenzhen Geno-immune Medical Institute, Shenzhen, Guangdong, China
https://ClinicalTrials.gov/show/NCT04299724
TREATMENT OF MILD CASES AND CHEMOPROPHYLAXIS OF CONTACTS AS PREVENTION OF THE COVID-19 EPIDEMIC
Drug: Antiviral treatment and prophylaxis|Other: Standard Public Health measures
Effectiveness of chemoprophylaxis assessed by incidence of secondary COVID-19 cases|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3|The mortality rate of subjects at weeks 2|Proportion of participants that drop out of study|Proportion of participants that show non-compliance with study drug
18 Years and older (Adult, Older Adult)
Phase 3
N= 3040
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
March 15, 2020-July 15, 2020
https://ClinicalTrials.gov/show/NCT04304053
COMPARISON OF LOPINAVIR/RITONAVIR OR HYDROXYCHLOROQUINE IN PATIENTS WITH MILD CORONAVIRUS DISEASE (COVID-19)
Drug: Lopinavir/ritonavir|Drug: Hydroxychloroquine sulfate
Viral load|Viral load change|Time to clinical improvement (TTCI)|Percentage of progression to supplemental oxygen requirement by day 7|Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7|Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission|Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7|adverse effects|Concentration of Lopinavir/ritonavir and hydroxychloroquine
16 Years to 99 Years (Child, Adult, Older Adult)
Phase 2
N=150
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 11, 2020-May 2020
Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of
https://ClinicalTrials.gov/show/NCT04307693
STUDY TO EVALUATE THE SAFETY AND ANTIVIRAL ACTIVITY OF REMDESIVIR (GS-5734™) IN PARTICIPANTS WITH SEVERE CORONAVIRUS DISEASE (COVID-19)
Drug: Remdesivir|Drug: Standard of Care
Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14|Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation
18 Years and older (Adult, Older Adult)
Phase 3
N=400
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 6, 2020-May 2020
Providence Regional Medical Center Everett, Everett, Washington, United States|Swedish Center for Comprehensive Care, Seattle, Washington, United States|Prince of Wales Hospital, Hong Kong, Hong Kong|Princess Margaret Hospital, Hong Kong, Hong Kong|Queen Mary Hospital, Hong Kong, Hong Kong|Kyungpook National University Hospital, Daegu, Korea, Republic of|Seoul Medical Center, Seoul, Korea, Republic of|National Medical Center, Seoul, Korea, Republic of|National University Hospital, Singapore, Singapore|National Centre for Infectious Diseases, Tan Tock Seng Hospital, Singapore, Singapore
https://ClinicalTrials.gov/show/NCT04292899
STUDY TO EVALUATE THE SAFETY AND ANTIVIRAL ACTIVITY OF REMDESIVIR (GS-5734™) IN PARTICIPANTS WITH MODERATE CORONAVIRUS DISEASE (COVID-19) COMPARED TO STANDARD OF CARE TREATMENT
Drug: Remdesivir|Drug: Standard of Care
Proportion of Participants Discharged by Day 14|Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation
18 Years and older (Adult, Older Adult)
Phase 3
N=600
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 2020
May 2020
Providence Medical Research Center, Everett, Washington, United States|Swedish Center for Comprehensive Care, Seattle, Washington, United States|Prince of Wales Hospital, Hong Kong, Hong Kong|Princess Margaret Hospital, Hong Kong, Hong Kong|Queen Mary Hospital, Hong Kong, Hong Kong|Kyungpook National University Hospital, Daegu, Korea, Republic of|Seoul Medical Center, Seoul, Korea, Republic of|National Medical Center, Seoul, Korea, Republic of|National University Hospital, Singapore, Singapore|National Centre for Infectious Diseases, Tan Tock Seng Hospital, Singapore, Singapore
https://ClinicalTrials.gov/show/NCT04292730
TETRANDRINE TABLETS USED IN THE TREATMENT OF COVID-19
Drug: Tetrandrine
Survival rate|body temperature
18 Years to 75 Years (Adult, Older Adult)
Phase 4
N=60
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 5, 2020-May 1, 2021
Tetrandrine Tablets, Jinhua, Zhejiang, China
https://ClinicalTrials.gov/show/NCT04308317
IMMUNITY AND SAFETY OF COVID-19 SYNTHETIC MINIGENE VACCINE
Biological: Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs
Clinical improvement based on the 7-point scale|Lower Murray lung injury score|28-day mortality|Duration of mechanical ventilation|Duration of hospitalization|Proportion of patients with negative RT-PCR results|Proportion of patients in each category of the 7-point scale|Proportion of patients with normalized inflammation factors|Frequency of vaccine/CTL Events|Frequency of Serious vaccine/CTL Events
6 Months to 80 Years (Child, Adult, Older Adult)
Phase 1|Phase 2
N=100
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 24, 2020-December 31, 2024
Shenzhen Geno-immune Medical Institute, Shenzhen, Guangdong, China
https://ClinicalTrials.gov/show/NCT04276896
BEVACIZUMAB IN SEVERE OR CRITICAL PATIENTS WITH COVID-19 PNEUMONIA-RCT
Drug: Bevacizumab
Proportion of patients whose oxygenation index increased by 100mmhg on the 7th day after admission
18 Years to 80 Years (Adult, Older Adult)
Not Applicable
N=118
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment
March 12, 2020-May 31, 2020
Qilu Hospital of Shandong University, Jinan, Shandong, China
https://ClinicalTrials.gov/show/NCT04305106
THE EFFICACY AND SAFETY OF THALIDOMIDE IN THE ADJUVANT TREATMENT OF MODERATE NEW CORONAVIRUS (COVID-19) PNEUMONIA
Drug: thalidomide|Drug: placebo
Time to Clinical recoveryTime to Clinical Recovery (TTCR)|All cause mortality|Frequency of respiratory progression|Time to defervescence
18 Years and older (Adult, Older Adult)
Phase 2
N=100
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
February 20, 2020-June 30, 2020
https://ClinicalTrials.gov/show/NCT04273529
THE EFFICACY AND SAFETY OF THALIDOMIDE COMBINED WITH LOW-DOSE HORMONES IN THE TREATMENT OF SEVERE COVID-19
Drug: placebo|Drug: Thalidomide
Time to Clinical Improvement (TTCI)|Clinical status|Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours|All cause mortality|Duration (days) of mechanical ventilation|Duration (days) of extracorporeal membrane oxygenation|Duration (days) of supplemental oxygenation|Length of hospital stay (days)|Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens|Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve.|Frequency of serious adverse drug events|Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment
18 Years and older (Adult, Older Adult)
Phase 2
N=40
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
February 18, 2020-May 30, 2020
https://ClinicalTrials.gov/show/NCT04273581
FINGOLIMOD IN COVID-19
Drug: Fingolimod 0.5 mg
The change of pneumonia severity on X-ray images
18 Years to 80 Years (Adult, Older Adult)
Phase 2
N=30
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 22, 2020-July 1, 2020
Wan-Jin Chen, Fuzhou, China
https://ClinicalTrials.gov/show/NCT04280588
THERAPY FOR PNEUMONIA PATIENTS IINFECTED BY 2019 NOVEL CORONAVIRUS
Biological: UC-MSCs|Other: Placebo
Size of lesion area by chest imaging|Blood oxygen saturation|Rate of mortality within 28-days|Sequential organ failure assessment|Side effects in the UC-MSCs treatment group|Electrocardiogram, the changes of ST-T interval mostly|Concentration of C-reactive protein C-reactive protein, immunoglobulin|CD4+ and CD8+ T cells count|Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α)|Concentration of the myocardial enzymes
18 Years to 75 Years (Adult, Older Adult)
Not Applicable
N=48
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment
February 24, 2020-February 1, 2021
Puren Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04293692
TREATMENT WITH MESENCHYMAL STEM CELLS FOR SEVERE CORONA VIRUS DISEASE 2019(COVID-19)
Biological: MSCs|Biological: Saline containing 1% Human serum albumin（solution of MSC）
Improvement time of clinical critical treatment index within 28 days|Side effects in the MSCs treatment group|Proportion of patients in each classification of clinical critical treatment index|All cause mortality on Day 28|Invasive mechanical ventilation rate|Duration of oxygen therapy(days)|Duration of hospitalization(days)|Incidence of nosocomial infection|CD4+ T cell count by flow cytometry in two groups
18 Years to 70 Years (Adult, Older Adult)
Phase 1|Phase 2
N=60
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
March 5, 2020-December 31, 2021
Wuhan Huoshenshan Hospital, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04288102
THE CLINICAL STUDY OF CARRIMYCIN ON TREATMENT PATIENTS WITH COVID-19
Drug: Carrimycin|Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate|Drug: basic treatment
Fever to normal time (day)|Pulmonary inflammation resolution time (HRCT) (day)|Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
18 Years to 75 Years (Adult, Older Adult)
Phase 4
N=520
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 23, 2020-February 28, 2021
Study Protocol, https://ClinicalTrials.gov/ProvidedDocs/03/NCT04286503/Prot_000.pdf|"Informed Consent Form", https://ClinicalTrials.gov/ProvidedDocs/03/NCT04286503/ICF_001.pdf
https://ClinicalTrials.gov/show/NCT04286503
EFFICACY AND SAFETY OF CORTICOSTEROIDS IN COVID-19
Drug: Methylprednisolone
the incidence of treatment failure in 14 days|clinical cure incidence in 14 days|the duration of virus change to negative|mortality at day 30|ICU admission rate in 30 days
18 Years and older (Adult, Older Adult)
Not Applicable
N=400
Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 14, 2020-May 30, 2020
Hubei province hospital of integrated Chinese & Western Medicine, Wuhan, Hubei, China|Yichang first people's Hospital, Yichang, Hubei, China|Renmin Hospital of Wuhan University, Wuhan, China|Tianyou Hospital Affiliated to Wuhan University of science and technology, Wuhan, China|Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology, Wuhan, China
https://ClinicalTrials.gov/show/NCT04273321
SAFETY RELATED FACTORS OF ENDOTRACHEAL INTUBATION IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA
Other: severe covid-19 pneumonia with ET
Success rate of intubation|Infection rate of Anesthesiologist|Extubation time
18 Years to 90 Years (Adult, Older Adult)
N=120
Observational Model: Case-Only|Time Perspective: Prospective
March 7, 2020-July 30, 2020
https://ClinicalTrials.gov/show/NCT04298814
Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19
Drug: YinHu QingWen Decoction|Drug: YinHu QingWen Decoction(low dose)|Other: Chinese medicine treatment|Other: standard western medicine treatment
Mean clinical recovery time (hours)|Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen|Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve.|Time to defervescence (in those with fever at enrolment)|Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)|Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate)|Frequency of requirement for supplemental oxygen or non-invasive ventilation|Frequency of respiratory progression|Severe case incidence|Proportion of re-hospitalization or admission to ICU|All-cause mortality|Frequency of serious adverse events
18 Years and older (Adult, Older Adult)
Phase 2|Phase 3
N=300
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment
February 27, 2020-January 2021
Jingzhou Hospital of Traditional Chinese Medicine, Jingzhou, Hubei, China|Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University, Wuhan, Hubei, China|Xiangyang Hospital of Traditional Chinese Medicine, Xiangyang, Hubei, China
https://ClinicalTrials.gov/show/NCT04278963
WASHED MICROBIOTA TRANSPLANTATION FOR PATIENTS WITH 2019-NCOV INFECTION
Other: washed microbiota transplantation|Other: placebo
Number of participants with improvement from severe type to common type
14 Years to 70 Years (Child, Adult, Older Adult)
Not Applicable
N=0
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
February 5, 2020-April 30, 2020
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
https://ClinicalTrials.gov/show/NCT04251767
VARIOUS COMBINATION OF PROTEASE INHIBITORS, OSELTAMIVIR, FAVIPIRAVIR, AND CHLOROQUIN FOR TREATMENT OF COVID19 : A RANDOMIZED CONTROL TRIAL
Drug: Oral
SARS-CoV-2 eradication time|Number of patient with Death|Number of patient with Recovery adjusted by initial severity in each arm|Number of day With ventilator dependent adjusted by initial severity in each arm|Number of patient developed Acute Respiratory Distress Syndrome After treatment
16 Years to 100 Years (Child, Adult, Older Adult)
Phase 3
N=80
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 15, 2020-November 30, 2020
Assistant Professor Subsai Kongsaengdao, Bangkok, Thailand
https://ClinicalTrials.gov/show/NCT04303299
PROGNOSITC FACTORS IN COVID-19 PATIENTS COMPLICATED WITH HYPERTENSION
Occupancy rate in the intensive care unit (ICU)|Mechanical Ventilation|Death|All cause mortality|Time from onset of symptoms to main outcome and its components|Time to Clinical Recovery
18 Years to 100 Years (Adult, Older Adult)
N=0
Observational Model: Cohort|Time Perspective: Retrospective
January 25, 2020-April 30, 2020
The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
https://ClinicalTrials.gov/show/NCT04272710
CLINICAL CHARACTERISTICS AND LONG-TERM PROGNOSIS OF 2019-NCOV INFECTION IN CHILDREN
The cure rate of 2019-nCoV.|The improvement rate of 2019-nCoV.|The incidence of long-term adverse outcomes.|Duration of fever|Duration of respiratory symptoms|Duration of hospitalization|Number of participant(s) need intensive care|Number of participant(s) with acute respiratory distress syndrome|Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.|Number of participant(s) who died during the trial
up to 18 Years (Child, Adult)
N=500
Observational Model: Cohort|Time Perspective: Prospective
February 15, 2020-December 31, 2020
Beijing Children's Hospital,, Beijing, China
https://ClinicalTrials.gov/show/NCT04270383
PROGNOSTIC FACTORS OF PATIENTS WITH COVID-19
all-cause mortality|Severe state
18 Years and older (Adult, Older Adult)
N=201
Observational Model: Cohort|Time Perspective: Retrospective
March 1, 2020-March 13, 2020
The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
https://ClinicalTrials.gov/show/NCT04292964
YINHU QINGWEN GRANULA FOR THE TREATMENT OF SEVERE COVID-19
Drug: Yinhu Qingwen Granula|Drug: Yin Hu Qing Wen Granula(low does)|Other: standard medical treatment
changes in the ratio of PaO2 to FiO2 from baseline|PaO2|blood oxygen saturation (SpO2)|clinical status rating on the 7-point ordinal scale|Time to Clinical Improvement (TTCI)|Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use|Duration (hours) of invasive mechanical ventilation use|Duration (hours) of extracorporeal membrane oxygenation (ECMO) use|Duration (days) of Oxygen use|The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment|The counts/percentage of Lymphocyte|Time to hospital discharge with clinical recovery from the randomisation|The incidence of critical status conversion in 30 days|All-cause mortality within 30 days|Frequency of severe adverse drug events
18 Years and older (Adult, Older Adult)
Phase 2|Phase 3
N=116
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
March 20, 2020-June 30, 2021
Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital, Wuhan, Hubei, China|Wuhan No.7 Hospital/North China University of Science and Technology Affiliated Hospital, Wuhan, Hubei, China|Zhongnan Hospital of Wuhan University/Tanshan People's Hospital, Wuhan, Hubei, China|Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04310865
CHLOROQUINE PREVENTION OF CORONAVIRUS DISEASE (COVID-19) IN THE HEALTHCARE SETTING
Drug: Chloroquine|Drug: Placebo
Number of symptomatic COVID-19 infections|Symptoms severity of COVID-19|Duration of COVID-19|Number of asymptomatic cases of COVID-19|Number of symptomatic acute respiratory illnesses|Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.
16 Years and older (Child, Adult, Older Adult)
Not Applicable
10000
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
May 2020
May 2022
https://ClinicalTrials.gov/show/NCT04303507
IMMUNOREGULATORY THERAPY FOR 2019-NCOV
Drug: PD-1 blocking antibody+standard treatment|Drug: Thymosin+standard treatment|Other: standard treatment
lung injury score|absolute lymphocyte counts|serum level of CRP, PCT and IL-6|SOFA score|all cause mortality rate|ventilation free days|ICU free days
18 Years and older (Adult, Older Adult)
Phase 2
120
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
February 10, 2020
October 31, 2020
https://ClinicalTrials.gov/show/NCT04268537
Sars-CoV2 Seroconversion Among Front Line Medical and Paramedical Staff in Emergency, Intensive Care Units and Infectious Disease Departments During the 2020 Epidemic
Other: blood sample
To assess the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff|Identification of risk factors for seroconversion|Quantify the proportion of asymptomatic infections among staff who have seroconverted|" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "
Child, Adult, Older Adult
Not Applicable
1000
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Other
March 11, 2020
October 12, 2020
Hopital Pitié Salpetrière, Paris, France
https://ClinicalTrials.gov/show/NCT04304690
EVALUATING THE EFFICACY AND SAFETY OF BROMHEXINE HYDROCHLORIDE TABLETS COMBINED WITH STANDARD TREATMENT/ STANDARD TREATMENT IN PATIENTS WITH SUSPECTED AND MILD NOVEL CORONAVIRUS PNEUMONIA (COVID-19)
Drug: Bromhexine Hydrochloride Tablets|Drug: Arbidol Hydrochloride Granules|Drug: Recombinant Human Interferon α2b Spray|Drug: Favipiravir Tablets
Time to clinical recovery after treatment|Rate of aggravation|Clinical remission rate|Dynamic changes of oxygenation index|Time to cure|rate to cure|Time to defervescence|Time to cough remission|Time to dyspnea remission|Days of supplemental oxygenation|Rate of patients with requring supplemental oxygen|Rate of patients with mechanical ventilation|Time of negative COVID-19 nucleic acid results|Rate of negative COVID-19 nucleic acid results|Rate of ICU admission|28-day mortality
18 Years to 80 Years (Adult, Older Adult)
Not Applicable
60
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 16, 2020
April 30, 2020
The Second AffIliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
https://ClinicalTrials.gov/show/NCT04273763
MILD/MODERATE 2019-NCOV REMDESIVIR RCT
Drug: Remdesivir|Drug: Remdesivir placebo
Time to Clinical recoveryTime to Clinical Recovery (TTCR)|All cause mortality|Frequency of respiratory progression|Time to defervescence (in those with fever at enrolment)|Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)|Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnoea at enrolment rated as severe or moderate,)|Frequency of requirement for supplemental oxygen or non-invasive ventilation|Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen|Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve.|Frequency of requirement for mechanical ventilation|Frequency of serious adverse events
18 Years and older (Adult, Older Adult)
Phase 3
308
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
February 12, 2020
April 27, 2020
Jin Yin-tan hospital, Wu Han, Hubei, China
https://ClinicalTrials.gov/show/NCT04252664
MESENCHYMAL STEM CELL TREATMENT FOR PNEUMONIA PATIENTS INFECTED WITH 2019 NOVEL CORONAVIRUS
Biological: MSCs
Size of lesion area by chest radiograph or CT|Side effects in the MSCs treatment group|Improvement of Clinical symptoms including duration of fever and respiratory|Time of nucleic acid turning negative|Rate of mortality within 28-days|CD4+ and CD8+ T celll count|Alanine aminotransferase|C-reactive protein|Creatine kinase
18 Years to 70 Years (Adult, Older Adult)
Phase 1
20
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
January 27, 2020
December 2021
Beijing 302 Military Hospital of China, Beijing, China
https://ClinicalTrials.gov/show/NCT04252118
THE EFFICACY OF INTRAVENOUS IMMUNOGLOBULIN THERAPY FOR SEVERE 2019-NCOV INFECTED PNEUMONIA
Drug: Intravenous Immunoglobulin|Other: Standard care
Clinical improvement based on the 7-point scale|Lower Murray lung injury score|28-day mortality|Duration of mechanical ventilation|Duration of hospitalization|Proportion of patients with negative RT-PCR results|Proportion of patients in each category of the 7-point scale|Proportion of patients with normalized inflammation factors|Frequency of Adverse Drug Events|Frequency of Serious Adverse Drug Events
18 Years and older (Adult, Older Adult)
Phase 2|Phase 3
80
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 10, 2020
June 30, 2020
https://ClinicalTrials.gov/show/NCT04261426
A PROSPECTIVE/RETROSPECTIVE,RANDOMIZED CONTROLLED CLINICAL STUDY OF ANTIVIRAL THERAPY IN THE 2019-NCOV PNEUMONIA
Drug: Abidol hydrochloride|Drug: Oseltamivir|Drug: Lopinavir/ritonavir
Rate of disease remission|Time for lung recovery|Rate of no fever|Rate of respiratory symptom remission|Rate of lung imaging recovery|Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery|Rate of undetectable viral RNA
18 Years and older (Adult, Older Adult)
Phase 4
400
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
February 1, 2020
July 1, 2020
Department and Institute of Infectious Disease, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04255017
A PROSPECTIVE/RETROSPECTIVE,RANDOMIZED CONTROLLED CLINICAL STUDY OF INTERFERON ATOMIZATION IN THE 2019-NCOV PNEUMONIA
Drug: Abidol hydrochloride|Drug: Abidol Hydrochloride combined with Interferon atomization
Rate of disease remission|Time for lung recovery|Rate of no fever|Rate of respiratory symptom remission|Rate of lung imaging recovery|Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery|Rate of undetectable viral RNA
18 Years and older (Adult, Older Adult)
Phase 4
100
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
February 1, 2020
July 1, 2020
Department and Institute of Infectious Disease, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04254874
A RANDOMIZED,OPEN,CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASC09F AND RITONAVIR FOR 2019-NCOV PNEUMONIA
Drug: ASC09F+Oseltamivir|Drug: Ritonavir+Oseltamivir|Drug: Oseltamivir
Rate of comprehensive adverse outcome|Time of clinical remission|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no need for oxygen inhalation|Rate of undetectable viral RNA|Rate of mechanical ventilation|Rate of ICU admission|Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
18 Years to 55 Years (Adult)
Phase 3
60
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
February 1, 2020
July 1, 2020
Department and Institute of Infectious Disease, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04261270
THE EFFICACY OF DIFFERENT HORMONE DOSES IN 2019-NCOV SEVERE PNEUMONIA
Drug: Methylprednisolone
Rate of disease remission|Rate and time of entering the critical stage|Rate of normal tempreture|Rate of respiratory symptom remission|Rate of lung imaging recovery|Rate of laboratory indicator recovery|Rate of undetectable viral RNA
18 Years and older (Adult, Older Adult)
Phase 4
100
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
February 1, 2020
July 1, 2020
Department and Institute of Infectious Disease, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04263402
TREATMENT OF PULMONARY FIBROSIS DUE TO 2019-NCOV PNEUMONIA WITH FUZHENG HUAYU
Drug: N-acetylcysteine+ Fuzheng Huayu Tablet|Drug: N-acetylcysteine+Placebo
High-resolution computed tomography (HRCT) score|Lung function including FVC, FVC as a percentage of projected value and DLco|Times of acute exacerbation|Six-minute walk distance|Dyspnea Scores|Composite physiological index
18 Years to 65 Years (Adult, Older Adult)
Phase 2
136
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
February 15, 2020
December 2022
Shuguang Hospital, Shanghai, Shanghai, China
https://ClinicalTrials.gov/show/NCT04279197
CT SCORES PREDICT MORTALITY IN 2019-NCOV PNEUMONIA
Other: CT score
7-day mortality
Child, Adult, Older Adult
39
Observational Model: Cohort|Time Perspective: Retrospective
January 31, 2020
February 18, 2020
Wuhan third hospital, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04284046
TREATMENT OF ACUTE SEVERE 2019-NCOV PNEUMONIA WITH IMMUNOGLOBULIN FROM CURED PATIENTS
Drug: Immunoglobulin of cured patients|Drug: γ-Globulin
Time to Clinical Improvement (TTCI)|Clinical status assessed by the ordinal scale|The differences in oxygen intake methods|Duration (days) of supplemental oxygenation|Duration (days) of mechanical ventilation|The mean PaO2/FiO2|The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days]|Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]|Dynamic changes of 2019-nCoV antibody titer in blood|Length of hospital stay (days)|All cause mortality
18 Years and older (Adult, Older Adult)
Not Applicable
10
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 17, 2020
May 31, 2020
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04264858
DEVELOPMENT AND VERIFICATION OF A NEW CORONAVIRUS MULTIPLEX NUCLEIC ACID DETECTION SYSTEM
Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform
16 Years to 100 Years (Child, Adult, Older Adult)
100
Observational Model: Cohort|Time Perspective: Retrospective
March 14, 2020
December 1, 2020
Huashan Hospital of Fudan University, Shanghai, Shanghai, China
https://ClinicalTrials.gov/show/NCT04311398
FAVIPIRAVIR COMBINED WITH TOCILIZUMAB IN THE TREATMENT OF CORONA VIRUS DISEASE 2019
Drug: Favipiravir Combined With Tocilizumab|Drug: Favipiravir|Drug: Tocilizumab
Clinical cure rate|Viral nucleic acid test negative conversion rate and days from positive to negative|Duration of fever|Lung imaging improvement time|Mortality rate because of Corona Virus Disease 2019|Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs|Mean in-hospital time
18 Years to 65 Years (Adult, Older Adult)
Not Applicable
150
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 8, 2020
May 2020
Anhui Medical University Affiliated First Hospital, Hefei, Anhui, China|Guiqiang Wang, Beijing, Beijing, China|Peking University First Hospital, Beijing, Beijing, China|Cancer Hospital Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China|Ezhou Central Hospital, Wuhan, Hubei, China|Huoshenshan Hospital of Wuhan, Wuhan, Hubei, China|Jinyintan Hospital of Wuhan, Wuhan, Hubei, China|Tongji Hospital of Huazhong University of Science and Technology, Wuhan, Hubei, China|West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan, Hubei, China|Wuhan Pulmonary Hospital, Wuhan, Hubei, China|Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04310228
NOVEL CORONAVIRUS INDUCED SEVERE PNEUMONIA TREATED BY DENTAL PULP MESENCHYMAL STEM CELLS
Biological: Dental pulp mesenchymal stem cells
Disppear time of ground-glass shadow in the lungs|Absorption of Lung shadow absorption by CT Scan-Chest|Changes of blood oxygen
18 Years to 75 Years (Adult, Older Adult)
Early Phase 1
24
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 5, 2020
July 30, 2021
https://ClinicalTrials.gov/show/NCT04302519
MULTICENTER CLINICAL STUDY ON THE EFFICACY AND SAFETY OF XIYANPING INJECTION IN THE TREATMENT OF NEW CORONAVIRUS INFECTION PNEUMONIA (GENERAL AND SEVERE)
Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection|Drug: Lopinavir/ritonavir treatment
Clinical recovery time
18 Years to 100 Years (Adult, Older Adult)
Not Applicable
80
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 14, 2020
April 14, 2021
https://ClinicalTrials.gov/show/NCT04295551
TOCILIZUMAB VS CRRT IN MANAGEMENT OF CYTOKINE RELEASE SYNDROME (CRS) IN COVID-19
Drug: Tocilizumab|Other: Standard of care|Procedure: Continuous renal replacement therapy
Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14|Duration of hospitalization|Proportion of Participants With Normalization of Fever Through Day 14|Change from baseline in white blood cell and differential count|Time to first negative in 2019 novel Corona virus RT-PCR test|All-cause mortality|Change from baseline in hsCRP|Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α|Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells
18 Years to 80 Years (Adult, Older Adult)
120
Observational Model: Cohort|Time Perspective: Retrospective
February 20, 2020
June 20, 2020
Tongji Hospital, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04306705
THE EFFECT OF T89 ON IMPROVING OXYGEN SATURATION AND CLINICAL SYMPTOMS IN PATIENTS WITH COVID-19
Drug: T89
The time to oxygen saturation recovery to normal level (≥97%)|The proportion of patients with normal level of oxygen saturation(≥97%)|The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc.|The time to the myocardial enzyme spectrum recovery to normal after treatment|The proportion of the patients with normal myocardial enzyme spectrum after treatment|The time to the electrocardiogram recovery to normal level after treatment|The proportion of the patients with normal electrocardiogram after treatment|The time to the hemodynamics recovery to normal after treatment|The proportion of the patients with normal hemodynamics after treatment|The time to exacerbation or remission of the disease after treatment;|The proportion of the patients with exacerbation or remission of disease after treatment|The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders|The all-cause mortality rate|The proportion of patients with acidosis|The total duration of the patients in-hospital|The total duration of oxygen inhalation during treatment|The oxygen flow rate during treatment|The oxygen concentration during treatment
18 Years to 85 Years (Adult, Older Adult)
Not Applicable
120
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 26, 2020
September 15, 2020
https://ClinicalTrials.gov/show/NCT04285190
RANDOMIZED CONTROLLED TRIAL OF LOSARTAN FOR PATIENTS WITH COVID-19 REQUIRING HOSPITALIZATION
Drug: Losartan|Other: Placebo
Sequential Organ Failure Assessment (SOFA) Respiratory Score|28-Day Mortality|90-Day Mortality|Respiratory Failure Requiring Mechanical Ventilation|Number of 28-Day Ventilator-Free Days|Length of Hospital Stay|ICU Admission|ICU Length of Stay|Acute Kidney Injury|Hypotension Requiring Vasopressors|Sequential Organ Failure Assessment (SOFA) Total Score|Severity Assessment|Incidence of Respiratory Failure|Oxygen Saturation / Fractional Inhaled Oxygen (F/S)
18 Years and older (Adult, Older Adult)
Phase 2
200
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
March 16, 2020
April 1, 2021
Hennepin County Medical Center, Minneapolis, Minnesota, United States|M Health Fairview University of Minnesota Medical Center, Minneapolis, Minnesota, United States|University of Minnesota, Minneapolis, Minnesota, United States
https://ClinicalTrials.gov/show/NCT04312009
RANDOMIZED CONTROLLED TRIAL OF LOSARTAN FOR PATIENTS WITH COVID-19 NOT REQUIRING HOSPITALIZATION
Drug: Losartan|Other: Placebo
Hospital Admission|Change in PROMIS Dyspnea Functional Limitations|Change in PROMIS Dyspnea Severity|Fever Incidence Day 3|Fever Incidence Day 5|Fever Incidence Day 7|Fever Incidence Day 10|Severity of Symptoms upon Hospital Admission
18 Years and older (Adult, Older Adult)
Phase 2
478
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
March 16, 2020
April 1, 2021
Hennepin County Medical Center, Minneapolis, Minnesota, United States|M Health Fairview University of Minnesota Medical Center, Minneapolis, Minnesota, United States|University of Minnesota, Minneapolis, Minnesota, United States
https://ClinicalTrials.gov/show/NCT04311177
STUDY OF HUMAN UMBILICAL CORD MESENCHYMAL STEM CELLS IN THE TREATMENT OF NOVEL CORONAVIRUS SEVERE PNEUMONIA
Biological: UC-MSCs|Drug: Placebo
Pneumonia severity index|Oxygenation index (PaO2/FiO2)|Side effects in the UC-MSCs treatment group|28-days survival|Sequential organ failure assessment|C-reactive protein|Procalcitonin|Lymphocyte count|CD3+, CD4+ and CD8+ T celll count|CD4+/CD8+ratio
18 Years to 65 Years (Adult, Older Adult)
Not Applicable
48
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 16, 2020
February 15, 2022
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04273646
CLINICAL STUDY OF ARBIDOL HYDROCHLORIDE TABLETS IN THE TREATMENT OF PNEUMONIA CAUSED BY NOVEL CORONAVIRUS
Drug: Arbidol|Other: basic treatment
Virus negative conversion rate in the first week|Virus negative conversion rate|Antipyretic rate|Symptom relief time|Finger oxygen improvement rate|Disease progression rate|Mortality rate|Incidence of severe adverse reactions|Change curve of peripheral blood lymphocyte count
18 Years to 75 Years (Adult, Older Adult)
Phase 4
380
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 7, 2020
December 30, 2020
https://ClinicalTrials.gov/show/NCT04260594
BEVACIZUMAB IN SEVERE OR CRITICAL PATIENTS WITH COVID-19 PNEUMONIA
Drug: Bevacizumab Injection
Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio|Degree of dyspnea (Liker scale)|Degree of dyspnea (VAS)|The area of lung lesions on Chest CT|The degree of lung exudation on Chest CT|SpO2|PaO2|CRP|hs-CRP|All-cause mortality
18 Years to 80 Years (Adult, Older Adult)
Phase 2|Phase 3
20
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 2020
May 2020
Qilu Hospital of Shandong University, Jinan, Shandong, China
https://ClinicalTrials.gov/show/NCT04275414
INTRAVENOUS AVIPTADIL FOR COVID-19 ASSOCIATED ACUTE RESPIRATORY DISTRESS
Drug: Aviptadil by intravenous infusion|Drug: Aviptadil by endotracheal nebulization
Mortality|PO2
18 Years to 100 Years (Adult, Older Adult)
Phase 2
20
Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
April 2020
September 2020
Research Facility, New York, New York, United States|Rambam Health Care Campus, Haifa, Israel
https://ClinicalTrials.gov/show/NCT04311697
EVALUATION OF GANOVO （DANOPREVIR ）COMBINED WITH RITONAVIR IN THE TREATMENT OF NOVEL CORONAVIRUS INFECTION
Drug: Ganovo+ritonavir+/-Interferon atomization|Drug: Long acting interferon|Drug: Recombinant cytokine gene-derived protein|Drug: Lopinavir+ritonavir|Drug: Chinese medicines +interferon atomization
Rate of composite adverse outcomes|Time to recovery|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no requiring supplemental oxygen|Rate of undetectable New coronavirus pathogen nucleic acid|Rate of mechanical ventilation|Rate of ICU admission|Rate of serious adverse event
18 Years to 75 Years (Adult, Older Adult)
Phase 4
50
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 17, 2020
April 30, 2020
The Ninth Hospital of Nanchang, Nanchang, Jiangxi, China
https://ClinicalTrials.gov/show/NCT04291729
EFFICACY OF A SELF-TEST AND SELF-ALERT MOBILE APPLET IN DETECTING SUSCEPTIBLE INFECTION OF COVID-19
Other: mobile internet survey on self-test
positive number diagnosed by national guideline in the evaluated population|distribution map of evaluated people|Effect of medical guidance by designated feedback questionnaire|mental scale of relief the mental anxiety and avoid unnecessary outpatient
Child, Adult, Older Adult
300000
Observational Model: Other|Time Perspective: Prospective
February 1, 2020
July 31, 2020
Beijing Tsinghua Changgung Hospital, Beijing, Beijing, China
https://ClinicalTrials.gov/show/NCT04256395
Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 Infection
Drug: Nitric Oxide
Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation|Mortality|Negative conversion of COVID-19 RT-PCR from upper respiratory tract|Time to clinical recovery
18 Years and older (Adult, Older Adult)
Phase 2
240
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 13, 2020
April 1, 2022
https://ClinicalTrials.gov/show/NCT04305457
ADAPTIVE COVID-19 TREATMENT TRIAL
Other: Placebo|Drug: Remdesivir
Percentage of subjects reporting each severity rating on the 7-point ordinal scale|Change from baseline in alanine transaminase (ALT)|Change from baseline in aspartate transaminase (AST)|Change from baseline in creatinine|Change from baseline in glucose|Change from baseline in hemoglobin|Change from baseline in platelets|Change from baseline in total bilirubin|Change from baseline in white blood cell count|Change in National Early Warning Score (NEWS) from baseline|Cumulative incidence of serious adverse events (SAEs)|Cumulative incidence of severe adverse events (AEs)|Discontinuation temporary suspension of infusions|Duration of hospitalization|Duration of new mechanical ventilation|Duration of new oxygen use|Incidence of new mechanical ventilation|Incidence of new oxygen use|Mean change in the ordinal scale from baseline|Number of oxygenation free days|Number of ventilator free days|Subject clinical status using ordinal scale|Subject mortality|Time to an improvement of one category from admission using an ordinal scale|Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first
18 Years to 99 Years (Adult, Older Adult)
Phase 2
394
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
February 21, 2020
April 1, 2023
University of California San Diego Health - Jacobs Medical Center, La Jolla, California, United States|University of California Irvine Medical Center - Infectious Disease, Orange, California, United States|University of California Davis Medical Center - Internal Medicine - Infectious Disease, Sacramento, California, United States|Emory Clinic - Investigational Drug Service, Atlanta, Georgia, United States|Emory Vaccine Center - The Hope Clinic, Decatur, Georgia, United States|University of Maryland School of Medicine - Center for Vaccine Development - Baltimore, Annapolis, Maryland, United States|Johns Hopkins Hospital - Medicine - Infectious Diseases, Baltimore, Maryland, United States|National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section, Bethesda, Maryland, United States|University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine, Minneapolis, Minnesota, United States|Saint Louis University - Center for Vaccine Development, Saint Louis, Missouri, United States|University of Nebraska Medical Center - Infectious Diseases, Omaha, Nebraska, United States|Montefiore Medical Center - Infectious Diseases, Bronx, New York, United States|University of Texas Medical Branch - Division of Infectious Disease, Galveston, Texas, United States|Baylor College of Medicine - Molecular Virology and Microbiology, Houston, Texas, United States|EvergreenHealth Infectious Disease Service, Kirkland, Washington, United States|The University of Washington - Virology Research Clinic, Seattle, Washington, United States|Providence Sacred Heart Medical Center, Spokane, Washington, United States|Seoul National University Bundang Hospital - Division of Infectious Diseases, Bundang-gu Seongnam-si, Gyeonggi-do, Korea, Republic of|Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of|National Centre for Infectious Diseases (NCID), Singapore, Singapore
https://ClinicalTrials.gov/show/NCT04280705
NITRIC OXIDE GAS INHALATION THERAPY FOR MILD/MODERATE COVID19 INFECTION
Drug: Nitric Oxide
Reduction in the incidence of intubation and mechanical ventilation|Mortality|Negative conversion of COVID-19 RT-PCR from upper respiratory tract|Time to clinical recovery
18 Years and older (Adult, Older Adult)
Phase 2
240
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 1, 2020
February 1, 2022
https://ClinicalTrials.gov/show/NCT04290858
ECULIZUMAB (SOLIRIS) IN COVID-19 INFECTED PATIENTS
Drug: Eculizumab
18 Years and older (Adult, Older Adult)
https://ClinicalTrials.gov/show/NCT04288713
SEVERE 2019-NCOV REMDESIVIR RCT
Drug: Remdesivir|Drug: Remdesivir placebo
Time to Clinical Improvement (TTCI) [Censored at Day 28]|Clinical status|Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.|All cause mortality|Duration (days) of mechanical ventilation|Duration (days) of extracorporeal membrane oxygenation|Duration (days) of supplemental oxygenation|Length of hospital stay (days)|Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens|Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve.|Frequency of serious adverse drug events
18 Years and older (Adult, Older Adult)
Phase 3
453
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
February 6, 2020
May 1, 2020
Bin Cao, Beijing, Beijing, China
https://ClinicalTrials.gov/show/NCT04257656
INFLUENCE OF THE COVID-19 EPIDEMIC ON STRESS
Stress|Perception and knowledge of the epidemic|Feeling of information on the part of companies / establishments / governments|Means of protection|Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients|Sociodemographic factors and lifestyle habits
Child, Adult, Older Adult
50000
Observational Model: Cohort|Time Perspective: Cross-Sectional
March 11, 2020
March 2022
University Hospital, Clermont-Ferrand, Clermont-Ferrand, France
https://ClinicalTrials.gov/show/NCT04308187
BLOOD DONOR RECRUITMENT DURING EPIDEMIC OF COVID-19
Other: Questionnaire with precaution information|Other: Experimental: Questionnaire without precaution information
Differences of attitude about blood donation towards different questionnaires|Rates of blood donation during 3 weeks
18 Years to 60 Years (Adult)
Not Applicable
1500
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Health Services Research
March 12, 2020
April 9, 2020
https://ClinicalTrials.gov/show/NCT04306055
MEDICAL MASKS VS N95 RESPIRATORS FOR COVID-19
Device: Medical Mask|Device: N95 respirator
RT-PCR confirmed COVID-19 infection|Acute respiratory illness|Absenteeism|Lower respiratory infection|Pneumonia|ICU admission|Mechanical ventilation|Death
18 Years and older (Adult, Older Adult)
Not Applicable
576
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
April 1, 2020
January 1, 2021
https://ClinicalTrials.gov/show/NCT04296643
ACCURATE CLASSIFICATION SYSTEM FOR PATIENTS WITH COVID-19 PNEUMONITIS
survival status
Child, Adult, Older Adult
669
Observational Model: Other|Time Perspective: Retrospective
December 10, 2019
March 4, 2020
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04302688
THE INVESTIGATION OF THE NEONATES WITH OR WITH RISK OF COVID-19
The death of newborns with COVID-19|The SARS-CoV-2 infection of neonates born to mothers with COVID-19|The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19|The small for gestational age newborns in the neonates born to mothers with COVID-19|The preterm delivery of neonates born to mothers with COVID-19|The disease severity of neonates with COVID-19
up to 28 Days (Child)
100
Observational Model: Case-Only|Time Perspective: Prospective
February 1, 2020
December 31, 2020
Maternal and Child Health Hospital of Hubei Province, Wuhan, Hubei, China|Children Hospital of Fudan University, Shanghai, Shanghai, China
https://ClinicalTrials.gov/show/NCT04279899
NITRIC OXIDE GAS INHALATION FOR SEVERE ACUTE RESPIRATORY SYNDROME IN COVID-19.
Drug: Nitric Oxide Gas
SARS-free patients at 14 days|Survival at 28 days|Survival at 90 days|SARS-free days at 28 days|SARS -free days at 90 days|Renal Replacement Therapy|Liver Failure|Mechanical Support of Circulation|PaO2/FiO2 ratio in ambient air
18 Years and older (Adult, Older Adult)
Phase 2
104
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment
March 1, 2020
March 1, 2022
https://ClinicalTrials.gov/show/NCT04290871
ANTI-SARS-COV-2 INACTIVATED CONVALESCENT PLASMA IN THE TREATMENT OF COVID-19
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7|Numbers of participants with different Clinical outcomes|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Child, Adult, Older Adult
15
Observational Model: Case-Only|Time Perspective: Prospective
February 1, 2020
December 31, 2020
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China
https://ClinicalTrials.gov/show/NCT04292340
IDENTIFYING CRITICALLY-ILL PATIENTS WITH COVID-19 WHO WILL BENEFIT MOST FROM NUTRITION SUPPORT THERAPY: VALIDATION OF THE NUTRIC NUTRITIONAL RISK ASSESSMENT TOOL
Other: Nutrition support
28-day all cause mortality|All cause infection|The rate of complications|Length of ICU stay|Duration of mechanical ventilation
18 Years and older (Adult, Older Adult)
100
Observational Model: Cohort|Time Perspective: Prospective
February 2020
July 2020
https://ClinicalTrials.gov/show/NCT04274322
EFFICACY AND SAFETY OF IFN-Α2Β IN THE TREATMENT OF NOVEL CORONAVIRUS PATIENTS
Drug: Recombinant human interferon α1β
The incidence of side effects|Time from patient enrollment to clinical remission|Proportion of patients with normal body|Proportion of patients without dyspnea|Proportion of patients without cough|Proportion|The negative conversion rate of new coronavirus nucleic acid|Frequency of serious adverse drug events.
18 Years and older (Adult, Older Adult)
Early Phase 1
328
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
March 1, 2020
June 30, 2020
https://ClinicalTrials.gov/show/NCT04293887
DETECTION OF 2019 NOVEL CORONAVIRUS IN MULTIPLE ORGAN SYSTEM AND ITS RELATIONSHIP WITH CLINICAL MANIFESTATIONS
Positive rate of 2019 Novel Coronavirus RNA|Survival rate
Child, Adult, Older Adult
20
Observational Model: Cohort|Time Perspective: Prospective
January 20, 2020
February 28, 2021
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
https://ClinicalTrials.gov/show/NCT04279795
CLINICAL FEATURES OF SUSPECTED AND CONFIRMED PATIENTS OF 2019 NOVEL CORONAVIRUS INFECTION
Other: Comprehensive treatment
Survival rate|Chest computed tomography|Recovery Time|Depression evaluation
Child, Adult, Older Adult
100
Observational Model: Cohort|Time Perspective: Prospective
January 20, 2020
February 28, 2021
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
https://ClinicalTrials.gov/show/NCT04279782
CLINICAL PROGRESSIVE CHARACTERISTICS AND TREATMENT EFFECTS OF 2019-NOVEL CORONAVIRUS
Mortality|The time interval of Nucleic acid detection become negative
18 Years to 75 Years (Adult, Older Adult)
400
Observational Model: Other|Time Perspective: Retrospective
January 1, 2020
July 31, 2020
Fujian Provincial Hospital, Fuzhou, Fujian, China
https://ClinicalTrials.gov/show/NCT04292327
UMBILICAL CORD(UC)-DERIVED MESENCHYMAL STEM CELLS(MSCS) TREATMENT FOR THE 2019-NOVEL CORONAVIRUS(NCOV) PNEUMONIA
Biological: UC-MSCs
Oxygenation index|28 day mortality|Hospital stay|2019-nCoV nucleic acid test|Improvement of lung imaging examinations|White blood cell count|Lymphocyte count|Lymphocyte percentage|Procalcitonin|interleukin(IL)-2|IL-4|IL-6|IL-8|IL-10|tumor necrosis factor(TNF)-α|γ-interferon(IFN)
18 Years to 75 Years (Adult, Older Adult)
Phase 2
10
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
February 6, 2020
September 30, 2020
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04269525
EVALUATING AND COMPARING THE SAFETY AND EFFICIENCY OF ASC09/RITONAVIR AND LOPINAVIR/RITONAVIR FOR NOVEL CORONAVIRUS INFECTION
Drug: ASC09/ritonavir group|Drug: lopinavir/ritonavir group
The incidence of composite adverse outcome|Time to recovery|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no requring supplemental oxygen|Rate of undectable viral RNA|Rate of mechanical ventilation|Rate of ICU admission|Time and rate of laboratory indicators related to disease improvement to return to normal
18 Years to 75 Years (Adult, Older Adult)
Not Applicable
160
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 7, 2020
June 30, 2020
https://ClinicalTrials.gov/show/NCT04261907
VITAMIN C INFUSION FOR THE TREATMENT OF SEVERE 2019-NCOV INFECTED PNEUMONIA
Drug: VC|Drug: Sterile Water for Injection
Ventilation-free days|28-days mortality|ICU length of stay|Demand for first aid measuments|Vasopressor days|Respiratory indexes|Ventilator parameters|APACHE II scores|SOFA scores
18 Years and older (Adult, Older Adult)
Phase 2
140
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment
February 14, 2020
September 30, 2020
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04264533
XIYANPING INJECTION FOR THE TREATMENT OF NEW CORONAVIRUS INFECTED PNEUMONIA
Drug: Xiyanping injection|Drug: Lopinavir / ritonavir, alpha-interferon nebulization
Clinical recovery time|Complete fever time|Cough relief time|Virus negative time|Incidence of severe or critical neocoronavirus pneumonia
18 Years to 70 Years (Adult, Older Adult)
Not Applicable
348
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 14, 2020
December 14, 2021
https://ClinicalTrials.gov/show/NCT04275388
DEVELOPMENT OF A SIMPLE, FAST AND PORTABLE RECOMBINASE AIDED AMPLIFICATION ASSAY FOR 2019-NCOV
Diagnostic Test: Recombinase aided amplification (RAA) assay
Detection sensitivity is greater than 95%|Detection specificity is greater than 95%|Consistent with existing universal reagent detection rates greater than 95%
1 Year to 90 Years (Child, Adult, Older Adult)
50
Observational Model: Cohort|Time Perspective: Prospective
January 1, 2020
December 31, 2020
Department of Hepatology Division 2, Beijing Ditan Hospital, Beijing, Beijing, China
https://ClinicalTrials.gov/show/NCT04245631
SAFETY AND IMMUNOGENICITY STUDY OF 2019-NCOV VACCINE (MRNA-1273) TO PREVENT SARS-COV-2 INFECTION
Biological: mRNA-1273
Frequency of solicited local reactogenicity adverse events (AEs)|Frequency of any medically-attended adverse events (MAAEs)|Frequency of any new-onset chronic medical conditions (NOCMCs)|Frequency of any serious adverse events (SAEs)|Frequency of any unsolicited adverse events (AEs)|Frequency of solicited systemic reactogenicity adverse events (AEs)|Grade of any unsolicited adverse events (AEs)|Grade of solicited local reactogenicity adverse events (AEs)|Grade of solicited systemic reactogenicity adverse events (AEs)|Geometric mean fold rise (GMFR) in IgG titer from baseline|Geometric mean titer (GMT) of antibody|Percentage of subjects who seroconverted
18 Years to 55 Years (Adult)
Phase 1
45
Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
March 3, 2020
June 1, 2021
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases, Seattle, Washington, United States
https://ClinicalTrials.gov/show/NCT04283461
2019-NCOV OUTBREAK AND CARDIOVASCULAR DISEASES
Cardiovascular Death|Major Adverse Cardiovascular Events|Times From symptom onset to hospital arrival|Anxiety
Child, Adult, Older Adult
N=12000
Observational Model: Case-Only|Time Perspective: Prospective
January 20, 2020
April 30, 2020
Affiliated Hospital of Binzhou Medical Universty, Binzhou, Shandong, China|Heze Municipal Hospital, Heze, Shandong, China|Shandong University Qilu Hospital, Jinan, Shandong, China|Jinan Central Hospital, Shandong University, Jinan, Shandong, China|First Hospital Affiliated with Shandong First Medical University, Jinan, Shandong, China|Shandong Provincial Hospital, Shandong University, Jinan, Shandong, China|The Second Hospital of Shandong University, Jinan, Shandong, China|Jining Hospital of Traditional Chinese Medicine, Jining, Shandong, China|Qihe People's Hospital, Qihe, Shandong, China|Affiliated Hospital of Qingdao University Medical College, Qingdao, Shandong, China|Weihai Municipal Hospital, Weihai, Shandong, China|Central Hospital of Zibo, Zibo, Shandong, China
https://ClinicalTrials.gov/show/NCT04255940
SOCIAL MEDIA USE DURING COVID-19
Behavioral: Use of social media during COVID-19
Assessment of COVID-19 situation|Depression, Anxiety and Stress Scale|Familiarity and trust in COVID-related rumours|Availability heuristic
21 Years and older (Adult, Older Adult)
5000
Observational Model: Cohort|Time Perspective: Cross-Sectional
March 8, 2020
May 31, 2020
Yale-NUS College, Singapore, Singapore
https://ClinicalTrials.gov/show/NCT04305574
MULTICENTER STUDY ON NOSOCOMIAL TRANSMISSION OF SARS-COV-2 VIRUS
Other: nosocomial infection/hospital acquired infection
nosocomial infection
Child, Adult, Older Adult
300
Observational Model: Cohort|Time Perspective: Prospective
March 9, 2020
October 30, 2020
Service Hygiène, Epidémiologie et Prévention, Lyon, France|Service Hygiène, Epidémiologie et Prévention, Lyon, France
https://ClinicalTrials.gov/show/NCT04290780
NITRIC OXIDE GAS INHALATION FOR SARS-COV-2
Drug: Nitric Oxide Gas
Change of arterial oxygenation at 48 hours from enrollment|Time to reach normoxemia during the first 28 days after enrollment|Proportion of SARS-nCoV-2 free patients during the first 28 days after enrollment|Survival at 28 days from enrollment|Survival at 90 days from enrollment
18 Years to 99 Years (Adult, Older Adult)
Phase 2
200
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
March 10, 2020
March 10, 2022
https://ClinicalTrials.gov/show/NCT04306393
A NEW SCREENING STRATEGY FOR 2019 NOVEL CORONAVIRUS INFECTION
Diagnostic Test: Standard screening strategy|Diagnostic Test: New screening strategy
Screening accuracy|Cost-effectiveness analysis
Child, Adult, Older Adult
Not Applicable
230
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Screening
February 2020
March 2020
the Fifth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, China
https://ClinicalTrials.gov/show/NCT04281693
VIRAL EXCRETION IN CONTACT SUBJECTS AT HIGH/MODERATE RISK OF CORONAVIRUS 2019-NCOV INFECTION
Biological: 2019-nCoV PCR
Number of Participants with presence of 2019-nCoV in at least one of nasopharyngeal swab|For each participant, time (days) between the last contact with the laboratory-confirmed 2019-nCoV case and the first positive PCR|For each participant, time (days) between the first positive PCR and the first negative PCR|Number of Participants with presence of at least one of the following symptoms: fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhe|Number of Participants with positive serology in the 90 days following last contact
Child, Adult, Older Adult
300
Observational Model: Cohort|Time Perspective: Prospective
February 4, 2020
February 4, 2021
CIC 1425, Paris, France
https://ClinicalTrials.gov/show/NCT04259892
EFFICACY AND SAFETY OF DARUNAVIR AND COBICISTAT FOR TREATMENT OF PNEUMONIA CAUSED BY 2019-NCOV
Drug: Darunavir and Cobicistat
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|The critical illness rate of subjects at weeks 2|The mortality rate of subjects at weeks 2
Child, Adult, Older Adult
Phase 3
30
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
January 30, 2020
December 31, 2020
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China|Shanghai Public Health Clinical Center, Shanghai, Shanghai, China
https://ClinicalTrials.gov/show/NCT04252274
EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE FOR TREATMENT OF PNEUMONIA CAUSED BY 2019-NCOV ( HC-NCOV )
Drug: Hydroxychloroquine
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5|The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7|The mortality rate of subjects at weeks 2|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|The critical illness rate of subjects at weeks 2
18 Years and older (Adult, Older Adult)
Phase 3
30
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 6, 2020
December 31, 2020
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China|Shanghai Public Health Clinical Center, Shanghai, Shanghai, China
https://ClinicalTrials.gov/show/NCT04261517
TREATMENT AND PREVENTION OF TRADITIONAL CHINESE MEDICINES (TCMS) ON 2019-NCOV INFECTION
Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules|Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
Time to complete remission of 2019-nCoV infection-associated symptoms|The incidence of dyspnea with low oxygen saturation level and high respiratory rate|Number of subjects who develop complications of 2019-nCoV infection|Time to virus shedding|Time to improvement of abnormalities in Chest radiology|The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment
14 Years to 80 Years (Child, Adult, Older Adult)
Not Applicable
150
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
January 22, 2020
January 22, 2021
The Fifth Medical Center, General Hospital of PLA, Beijing, Beijing, China
https://ClinicalTrials.gov/show/NCT04251871
A SURVEY OF PSYCHOLOGICAL STATUS OF MEDICAL WORKERS AND RESIDENTS IN THE CONTEXT OF 2019 NOVEL CORONAVIRUS PNEUMONIA
GHQ-12(general health questionnaire-12)|IES-R(Impact of Event Scale-Revised)
Child, Adult, Older Adult
N=30000
Observational Model: Case-Only|Time Perspective: Prospective
February 3, 2020
April 20, 2020
Tongji Hospital，Tongji Medical College Affiliated，Huazhong University of Science ＆ Technology, Wuhan, Hubei, China
https://ClinicalTrials.gov/show/NCT04260308
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
Drug: Meplazumab for Injection
2019 nCoV nucleic acid detection|Recovery of body temperature|Recovery of resting respiratory rate|Recovery of SPO2|Chest CT / chest film changes|PaO2 / FiO2|Time to reach the isolation release standard|Changes of inflammatory immune status
18 Years to 75 Years (Adult, Older Adult)
Phase 1|Phase 2
20
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 3, 2020
December 31, 2020
Tangdu Hospital, Xi'an, Shaanxi, China
https://ClinicalTrials.gov/show/NCT04275245
Acute Respiratory Failure and COVID-19 in Real Life
Other: standard operating procedures
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection|in-hospital mortality|30 days mortality|6 months mortality|Intubation rate|Time to Intubation|Time to ventilation|Non invasive to Invasive time|Recovery rate|Recurrence rate|Risk factor for COVID19|Blood tests and outcome|Antiviral therapy|Coinfections|Radiological findings|Ultrasound findings|Myocardial injury|Medical management
18 Years and older (Adult, Older Adult)
50
Observational Model: Cohort|Time Perspective: Prospective
March 19, 2020
December 31, 2020
Luigi Sacco University Hospital, Milan, Lombardia, Italy
https://ClinicalTrials.gov/show/NCT04307459
Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19
Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis
Determine the number of Covid-19 patients who were unable to complete SCE Therapy|Examine the percentage of activated T cells after SCE therapy by flow cytometry|Assess the percentage of Th17 cells after SCE therapy by flow cytometry|Chest imaging changes by computed tomography (CT) scan of the chest|Quantification of the SARS-CoV-2 viral load by real time RT-PCR
18 Years to 60 Years (Adult)
Phase 2
20
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Care Provider)|Primary Purpose: Treatment
April 10, 2020
November 10, 2020
https://ClinicalTrials.gov/show/NCT04299152
EXPANDED ACCESS REMDESIVIR (RDV; GS-5734™)
Drug: Remdesivir
Child, Adult, Older Adult
https://ClinicalTrials.gov/show/NCT04302766
Sero-epidemiological Survey of England in 2019/2020 (STORY)
Procedure: venepuncture
Feasibility of developing a UK based sero-epidemiological programme in 0-24 year olds|Feasibility of developing a UK based sero epidemiological survey in 0-24 year olds|Recruitment
up to 24 Years (Child, Adult)
2300
Observational Model: Other|Time Perspective: Prospective
October 15, 2019
November 30, 2020
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), Oxford, Oxfordshire, United Kingdom
https://ClinicalTrials.gov/show/NCT04061382
CLINICAL OUTCOMES OF PATIENTS WITH COVID19
Other: retrospective analysis
Time to negative conversion of severe acute respiratory syndrome coronavirus 2|Length of stay in hospital|Survival|Intubation
Child, Adult, Older Adult
50
Observational Model: Cohort|Time Perspective: Retrospective
February 22, 2020
March 31, 2020
HuiZhou Municipal Central Hospital, Huizhou, Guangdong, China
https://ClinicalTrials.gov/show/NCT04280913
NK CELLS TREATMENT FOR NOVEL CORONAVIRUS
Biological: NK Cells
Improvement of clinical symptoms including duration of fever|Improvement of clinical symptoms including respiratory frequency|Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0|Time of virus nucleic acid test negative|CD4+ and CD8+ T cell count|Rate of mortality within 28-days|Size of lesion area by thoracic imaging
18 Years to 65 Years (Adult, Older Adult)
Phase 1
30
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 20, 2020
December 30, 2020
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
https://ClinicalTrials.gov/show/NCT04280224
GLUCOCORTICOID THERAPY FOR NOVEL CORONAVIRUSCRITICALLY ILL PATIENTS WITH SEVERE ACUTE RESPIRATORY FAILURE
Drug: methylprednisolone therapy|Other: Standard care
Lower Murray lung injury score|The difference of PaO2/FiO2 between two groups|Lower Sequential Organ Failure Assessment (SOFA) score|Mechanical ventilation support|Clearance of noval coronavirus|All-cause mortality
18 Years and older (Adult, Older Adult)
Phase 2|Phase 3
80
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
January 26, 2020
December 25, 2020
Medical ICU,Peking Union Medical College Hospital, Beijing, Beijing, China
https://ClinicalTrials.gov/show/NCT04244591
LOPINAVIR/ RITONAVIR, RIBAVIRIN AND IFN-BETA COMBINATION FOR NCOV TREATMENT
Drug: Lopinavir/ritonavir|Drug: Ribavirin|Drug: Interferon Beta-1B
Time to negative NPS|Time to negative saliva|Time to clinical improvement|Hospitalisation|Mortality|Immune reaction|Adverse events|Time to negative all clinical specimens
18 Years and older (Adult, Older Adult)
Phase 2
70
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 10, 2020
July 31, 2022
University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong
https://ClinicalTrials.gov/show/NCT04276688
POST-EXPOSURE PROPHYLAXIS FOR SARS-CORONAVIRUS-2
Drug: Hydroxychloroquine|Other: Placebo
Incidence of COVID19 Disease|Ordinal Scale of COVID19 Disease Severity|Incidence of Hospitalization|Incidence of Death|Incidence of Confirmed SARS-CoV-2 Detection|Incidence of Symptoms Compatible with COVID19 (possible disease)|Incidence of All-Cause Study Medicine Discontinuation or Withdrawal
18 Years and older (Adult, Older Adult)
Phase 2|Phase 3
1500
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
April 2020
May 2021
University of Minnesota, Minneapolis, Minnesota, United States
https://ClinicalTrials.gov/show/NCT04308668
French COVID Cohort (FrenchCOVID)
Clinical features|Response to treatment|Pathogen replication, excretion and evolution, within the host|Immune host responses to infection and therapy|Host genetic variants
Child, Adult, Older Adult
500
Observational Model: Other|Time Perspective: Prospective
February 7, 2020
August 7, 2023
CHU Pellegrin, service des Maladies Infectieuses et Tropicales, Bordeaux, France|APHP La Pitié Salpêtrière, service des Maladies Infectieuses et Tropicales, Paris, France|APHP Bichat, Service de réanimation médicale et infectieuse, Paris, France|APHP Bichat, Service des Maladies Infectieuses et Tropicales, Paris, France
https://ClinicalTrials.gov/show/NCT04262921
A PILOT CLINICAL STUDY ON INHALATION OF MESENCHYMAL STEM CELLS EXOSOMES TREATING SEVERE NOVEL CORONAVIRUS PNEUMONIA
Biological: MSCs-derived exosomes
Adverse reaction (AE) and severe adverse reaction (SAE)|Time to clinical improvement (TTIC)|Number of patients weaning from mechanical ventilation|Duration (days) of ICU monitoring|Duration (days) of vasoactive agents usage|Duration (days) of mechanical ventilation supply|Number of patients with improved organ failure|Rate of mortality
18 Years to 75 Years (Adult, Older Adult)
Phase 1
30
Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
February 15, 2020
July 31, 2020
https://ClinicalTrials.gov/show/NCT04276987
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COVID-19 Resources for Clinical Researchers and Students
COVID-19 Resources for Clinical Researchers and Students
At CCRPS, we will be continuing all remote learning courses for our students. We suggest you stay at home to review each module rather than at a library or coffee shop to protect both yourself and your family members. If you need an extension on your course due to the current events, please contact Dr. Desai at pdesai@ccrps.org any time.
We wanted to share resources which will help curious minds in clinical research (like ourselves) stay current with the quick changes occurring in response to COVID-19.
COVID-19 & Management - EMCRIT
This resource by Emergency Critical Care provides clinically relevant information on the pathophysiology, clinical diagnoses, testing, and potential treatments for COVID-19.
Mass General COVID-19 Grand Rounds
The Mass General Grand Rounds on 3/12/20 by the BCPR provides information on the Timeline of Spread, Epidemiology, COVID-19 pathophysiology, Vaccine development, Pharmacology, and more important topics needed to understand the current status of the pandemic.
Vaccine Trial for SARS COV-2
The Vaccine Trial is currently in Phase 1 with a current estimated end date of January 2021 at Kaiser in Seattle, WA. For those interested in a deeper dive into clinical trial management, consider the Advanced Clinical Research Project Manager Certification.
ClinicalTrials.Gov Trials for COVID-19
There are over 80 Clinical Trials being conducted for COVID-19 listed on the ClinicalTrials.gov website, useful for all clinical researchers to review. Enhance your expertise by exploring courses like Clinical Research Coordinator or Clinical Trials Assistant Training.
CDC COVID-19 Page
The CDC is the main source of clinical practice and laboratory practice guidelines relevant to all healthcare professionals. For those involved in drug safety, the Pharmacovigilance Certification could be of interest.
UptoDate Open Access Page on COVID-19
UptoDate has now made their COVID-19 page (draft; not completed peer-review) available with citations of important literature in the past few months. This is a great reference tool. For detailed guidelines and practices, consider the ICH-GCP Training.
We wish you well and hope you stay safe, practice social distancing as needed, and use this opportunity if home to learn more.
Take courses from CCRPS and learn more on how to become a clinical research professional. Discover more from Certified Clinical Research Professionals Course.
Additionally, for those looking to specialize further, explore the Advanced Principal Investigator Physician Certification and Medical Monitor Certification.
An Overview of Covance CRO Clinical Research I Covance Clinical Trials
Covance CRO
With the increasing demand for skilled professionals in clinical research, it's imperative to consider courses that can equip individuals with the necessary expertise. Covance, as a renowned clinical research organization (CRO), underscores the importance of having trained personnel to ensure the safety and efficacy of clinical trials.
For those aspiring to venture into clinical research, courses such as Clinical Research Coordinator and Pharmacovigilance Certification can provide fundamental knowledge and skills. These courses cover essential aspects of clinical trial management and drug safety, preparing individuals to contribute effectively to research endeavors. Similarly, the CRA (Clinical Research Associate) course equips learners with the expertise needed to monitor clinical trials according to regulatory standards, including the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
Moreover, individuals interested in supporting clinical trials as assistants can benefit from specialized training programs like Clinical Trials Assistant Training. These courses offer insights into the administrative and logistical aspects of clinical research, enhancing participants' ability to contribute to the smooth conduct of trials.
For those seeking advanced roles in clinical research management, certifications such as Advanced Clinical Research Project Manager and Advanced Principal Investigator Physician provide comprehensive training in leadership, project management, and regulatory compliance. These certifications are valuable assets for professionals aspiring to take on leadership positions within the clinical research industry.
Furthermore, specialized roles such as Medical Monitor Certification cater to professionals involved in overseeing the medical aspects of clinical trials, ensuring participant safety and protocol adherence.
By enrolling in these courses, individuals can acquire the necessary qualifications and skills to thrive in the dynamic field of clinical research, contributing to the advancement of medical science and improving human health.
Explore our courses: Clinical Research Coordinator
Pharmacovigilance Certification
Clinical Trials Assistant Training
Advanced Clinical Research Project Manager Certification
Advanced Principal Investigator Physician Certification
Covance Clinical Trials
Clinical trials go through carefully planed phases to reliably verify a drug. Any medicine available from your local pharmacy are the result of cumulative efforts of volunteer Participants. Without them, medical science will grind to a halt.
Covance is dedicated to delivering solutions and advancing the healthcare sector. This company has decades of expertise and precision in this field. If you are interested in how you can volunteer for a study, you can check out their website here.
Explore COVANCE’s broad range of specialized services:
Preclinical Reach IND/CTA quickly with a programmatic approach or choose from thousands of studies.
Clinical Trials Remove roadblocks to early & late trials with intelligent recruitment, integrated project delivery and therapeutic expertise.
Post-Marketing Solutions Maximize your product’s value and ensure patients have access to safe and effective treatments.
Clinical Trial Laboratory Services Comprehensive laboratory support for all phases of clinical trials.
Chemical & Crop Protection Meet global crop protection and chemical guidelines with expertise paired with regulatory insights.
Medical Devices Leverage a specialized team and powerful collection of resources for every step of product development.
Improve clinical study outcomes with unrivaled, proprietary data and technology.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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Where are Clinical Research CROs Growing?
The field of clinical research is one that has become very important. More than ever before, there are CROs (clinical research organizations) popping up everywhere in the world.
CROs are responsible for supporting pharmaceutical companies, medical device industries, biotechnology companies, government institutions, and so on with outsourced research services. The presence of CROs all over the world has made it possible to conduct more clinical trials at one time. In addition, they have helped increase the success rate of clinical trials by providing the clinical researchers with information that are necessary for their own subsequent researches to be successful.
The presence of CROs in USA have helped to improve the quality of healthcare service in the country and in the world at large. No matter where you live in USA, there are a lot of clinical researches going on around you and there are more clinical research organizations in Los Angeles, Chicago, new York, Philadelphia etc.
It is important to state clearly that the United States of America is not the only country that conduct clinical research, and thus it not the only place where it thrives. There are different clinical research centers all over the world.
In the United Kingdom, the field of clinical research has become very important. UK clinical research also has a lot of opportunities for aspiring clinical researchers.
Other countries like India also have a strong clinical research presence and although it is a competitive field, it’s not so difficult to get clinical research jobs in India.
Everywhere you go in the world, there are a plethora of clinical researches going on in different cities and locations all over the world. Clinical research is closer to you than you think.
If you’ll like to find out more about clinical research, check ccrps.org for access to the best clinical research consultation.
Take courses from CCRPS and learn more on how to become a clinical research professional:
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Clinical Research Opportunities in New York City
Clinical research in New York has been on the rise in recent years. New York City is known for its advancement in clinical research and management.
Participating in a clinical research in New York is beneficial to the participants and it is a way for you as the participant to help people with such health issues and also contribute to the medical sciences. Popular benefits include:
Getting free medical care.
Being involved actively.
It helps you to improve your lifestyle for better health.
You have access to and benefit from new treatments that are not yet available for the general public.
Clinical research in US have been ongoing for a long time. With every discovery and advancement, it becomes more important part of healthcare. If you are interested in being a clinical researcher in US, you can get all the help that you will need to be successful at CCRPS. From knowledge to experience to degree and certification, you will get all the needed help from experts and professionals in the clinical research industry that are willing and ready to set you on the right path.
Interested in pursuing a career in clinical research? Explore the array of courses offered by CCRPS:
Clinical Research Coordinator: Learn more about coordinating clinical research studies. Clinical Research Coordinator Course
Pharmacovigilance Certification: Dive into the essentials of pharmacovigilance. Pharmacovigilance Certification Course
CRA (Clinical Research Associate): Explore the responsibilities and skills required for a CRA role. CRA Course
ICH-GCP (International Conference on Harmonisation of Good Clinical Practice): Understand the guidelines for conducting clinical trials. ICH-GCP Course
Clinical Trials Assistant Training: Gain expertise in assisting with clinical trials. Clinical Trials Assistant Training Course
Advanced Clinical Research Project Manager Certification: Elevate your career with advanced project management skills. Advanced Clinical Research Project Manager Certification Course
Advanced Principal Investigator Physician Certification: Take your expertise as a physician to the next level in clinical research. Advanced Principal Investigator Physician Certification Course
Medical Monitor Certification: Enhance your skills as a medical monitor in clinical trials. Medical Monitor Certification Course
Empower yourself with the knowledge and skills needed to excel in the field of clinical research through CCRPS. Explore our Clinical Research Training programs today!
Clinical Researchs Regulations
Clinical research regulations are set in place to make sure that all clinical research projects are conducted in accordance with international principles. The following regulations are the basics of the clinical research profession, and good for any aspiring professionals to know.
Good Manufacturing Practice (GMP)
This regulation is set in place to ensure that manufactures investigational medications and products to be safe and meet standards. This ensures that all participants involved in the clinical trials are not exposed to poor, harmful, and ineffective drugs. For those interested in further enhancing their knowledge and skills in this area, consider enrolling in the Advanced Clinical Research Project Manager Certification course.
Good Clinical Practice (GCP)
Good clinical practice is a major regulation that is set in place to conduct all clinical trials in accordance with the internationally recognized principles of the ICH GCP. It is there to ensure that risks to patients and volunteers are minimized. If you are looking to build a foundation in this critical area, our ICH GCP course can be an excellent resource.
Good Clinical Practice and Good Manufacturing Practice inspections and Enforcement
The MHRA checks the principles and standards of the GMP and GCP to ensure quality and that compliance are followed. They also help identify non-compliance and provide enforcement power. To learn more about roles in this regulatory field, explore our Medical Monitor Certification course.
Incapacitated Adult's Protection
This regulation is set in place to protect adults that are incapable of giving informed consent (e.g advanced Alzheimer's disease). The decision to consent to, refuse, or participate in a trial is made by an independent "consultee" that would act on the basis of the incapacitated adult wishes. Enhance your understanding of such roles with the Advanced Principal Investigator Physician Certification.
Minor's Protection
This regulation is set in place to protect minors (persons under the age of 16) and ensure that the following before a minor’s participation in trials:
REC consideration of receiving advice on the pediatric care relevant field.
A parent, custodian, guardian, or legal representative must give informed consent.
The minor should be informed of the risks and benefits of the trial according to their understanding capacity by staff experienced with young people.
The minor's wishes to be withdrawn from the trial or refusal to participate from the trial should be considered.
The clinical trial must be directly related to the illnesses the minor suffers from.
The clinical trial must directly benefit the minor involved.
To delve deeper into regulations protecting minors and their application in clinical trials, our Clinical Trials Assistant Training provides comprehensive insights.
Pharmacovigilance Arrangements
This regulation takes into account all the clinical trials of an IMP. It ensures that the reviews of adverse events and processing of serious adverse events are reported immediately to sponsors. In addition, it mandates that there must be a record of suspected unexpected serious adverse reactions caused by the trial medicines and that they must be reported to the MHRA. For those interested in specializing in this critical aspect of clinical trials, consider our Pharmacovigilance Certification.
If you want to learn more about the regulations of clinical research, take our free ICH GCP course. This course will help you build the knowledge for a solid foundation for a career in clinical research.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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Why Should You Take Clinical Research Training
Clinical Research training is a prerequisite for all certification as clinical research professionals. Clinical research training is committed to providing support to facilitate the highest possible quality in clinical research. CCRPs provides training opportunities for faculty and research staff to ensure that research is carried out efficiently and appropriately. It also takes into account the safety of Clinical research.
The clinical research training program includes professional development for the whole clinical research faculty, this includes; clinical research nurses, clinical research coordinators, clinical research data managers, clinical research regulatory officers, clinical research administrative officers, and clinical research financial staff. The training is for anyone who is a clinical research professional or is involved in clinical research.
Clinical research training can be done online or in institutions, and it is done to maintain broad-based information on the local state federal and institutional requirements that are needed to initiate and manage clinical research. It includes detailed knowledge about the specifics of implementing research concrete system for educating and updating those involved in clinical, translational research and also observational research about the compliance and regulatory requirements and procedures of the clinical research. The training program is also designed to help educate research staff on how to resolve problems encountered in their work environment.
Courses are open to all faculty and clinical research staff including the support staff. They include the following;
Good clinical practice training (ICH-GCP) also is known as GCP. GCP is very important as sponsors and are asking of it before initiating trials. GCP training twice a year and it's done face-to-face with experience, competent, and qualified GCP instructors
Introduction to a clinical trial. Although we at CCRPS do not offer clinical trials it is a prerequisite to understanding clinical research procedures.
CCRPs offers the lowest fees for online courses there are over 110 courses to choose from and all of them are for a little fee per year. With the online clinical research training from CCRPS, you can go on to establish a name for yourself in the clinical research industry. Clinical research managers and clinical research Associates (CRA) are the hotcakes in the clinical research industry presently. They are by far the most wanted clinical research professionals earning on an average nothing less than $55000 at least and over $120,000 per annum.
Make the smart choice today, switch to CCRPS take the online courses and upgrade your career.
Take courses from CCRPs and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course.
Clinical Research Trends For 2024
Looking at 2018, there are several shifts in clinical trial outsourcing trends that sponsors and vendors should be aware of. Many of these trends are driven by regulations and industry guidelines, as well as a growing need for new therapies.
In 2017, there was a slight increase in clinical outsourcing penetration as it grew from 43 percent to 45 percent (Clinical Leader). While the majority of outsourcing still lies with large, full service CROs, the percentage of work going to specialist CROs is growing due to a need for experts in therapeutic areas and indications, regulatory requirements and pharmacovigilance.
Below is a look at trends in outsourcing that shaped 2024:
TECHNOLOGY INVOLVEMENT
Sure, technology has been an ongoing trend in clinical trials for years. Technologies such as Electronic Data Capture (EDC), Patient Recorded Outcomes (PRO) and Clinical Trial Management Systems (CTMS) have become part of the norm. However technology is now playing a bigger role in the overall clinical study strategy. Tech giants such as Google, Amazon, and Apple are also looking for a chunk of the clinical trial sector by developing technologies that are patient-centric. Market leaders such as Medidata, Oracle and Veeva are continuing to develop extensive technology platforms for clinical trials.
DATA ANALYTICS ARE FUNDAMENTAL
Centralized statistical monitoring is being mentioned more frequently as sponsors look to facilitate risk-based monitoring with real-time, accurate metrics. Data analytics will play an even greater role in crucial strategic decisions for Sponsors.
PHARMACOVIGILANCE OUTSOURCING (PVO) ON THE RISE
Pharmacovigilance outsourcing got its own acronym and some additional attention in 2018. The management and reporting of adverse events is becoming a complex business and new regulations are making it more difficult for sponsors to keep up without support from specialized experts. Enhance your expertise with a Pharmacovigilance Certification.
BIOTECH GOING AT IT ALONE?
Biotechs have often looked to large pharma partnerships to carry their compounds into late phase trials and on to approval. Biotechs now have multiple outsourcing models available including Functional Service Provision to allow them to continue developing their product.
RISE OF STRATEGIC PARTNERSHIP MODEL AND FSP
Over 60 percent of Sponsors have started outsourcing in-house activities to “strategic partners”. For clinical, data, regulatory and clinical IT solutions, Sponsors are increasingly looking to the Functional Service Provision model.
Whether you’re considering a career in clinical research management or looking for a job in that field, here’s a round-up of the info you need to know. Advance your career with specialized certifications like Advanced Clinical Research Project Manager, Advanced Principal Investigator Physician, or Medical Monitor.
The average pay for a Clinical Research Manager is $32.27 per hour. The average pay for a Clinical Research Manager is $77,532 per year. Is Clinical Research Manager your job title? Get a personalized salary report!
Where is a Clinical Research Manager likely to work?
A Clinical Research Manager can work for a number of different and exciting organizations, including a:
Pharmaceutical company
Government-based organization – the Medicines and Healthcare products Regulatory Agency (MHRA)
A non-governmental organisation (NGO) – World Health Organization (WHO)
Health charity
Take a look at latest vacancies in clinical research today!
Begin your career with comprehensive training as a Clinical Research Coordinator, CRA, or Clinical Trials Assistant.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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Why Are Clinical Research Seminars Important
The purpose of the clinical research seminars is to impact the attendees with knowledge about important aspects of clinical research, such as the professional ethics, operational aspect and regulations. Education and training are very important in this field and vital to the success of trials. Seminars are another way of training clinical research professionals or other related professionals that have an interest in the field.
Seminars can be held every two weeks, monthly or quarterly. It depends totally on the organizers and what they aim to achieve with the seminar. For example, some organizers may hold a biweekly seminar for young interns to help them improve their knowledge and sharpen their clinical research skills.
Clinical research seminars are ideal for the following sets of people:
Nurses
Regulatory experts
Other staff also involved in clinical research can as well attend the seminar to improve their knowledge. Common topics that are discussed at the seminars include :
Professional ethics of clinical researchers.
Auditing clinical trials
Advanced quality monitoring
Monitoring oncology trials
Current regulations
Inspection preparation
Resources involved with clinical research.
Guidelines pertaining to clinical research.
These seminars are usually handled by experts and professionals in the clinical research industry. They are usually have worked with different leading pharmaceutical companies biotechnological companies, device companies, and leading academic institutions.
Clinical research seminars can also provide extra benefits. This depends a lot on who the organizers are, but some clinical research seminars provide those in attendance with SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research Professionals) and CME Continuing Education Credit hours.
Apart from seminars organized by different institutions that an individual can apply for, seminars can also be organized for in-house training. They can be tailored to meet your company's specific needs. Organizers can provide your company with a set of training options that range from single topic seminar presentation to more comprehensive programs. For instance, some organizers make use of different hands on approach by providing activities and simulated case studies to help the audience's learning process.
As an individual you can register yourself to become a participant of upcoming clinical research seminars at ccrps.org. As an organization or company as well, you can register your staffs for these seminars. As a company, you can register for in-house training, where the seminars can be tailored for your specific needs.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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Clinical Research Training For Employers
Clinical Research Training For Employers
No employer in any field or industry employs a staff without a prior knowledge, ability or competence in carrying out their supposed duty and fulfilling their job description. It is the same with the clinical research industry as well. Examples of employers in this industry are pharmaceutical companies, biotech companies, clinical research organizations, government agencies etc. These companies and organizations all require a minimum level of training that individuals must possess before they can be considered employable. There are minimum educational requirements, certification and certain other skills that employers consider before employing a clinical research professional.
However, because of the nature of medical science, the growth and evolution of science and the advancement of technology, here is a constant need for clinical research professionals. This has increased the importance of clinical research training for employers.
Employers who want to increase the level of professionalism and competence among their staffs often enroll them for online and offline training programs. There are different variations of these programs, depending on the training platform. Some of these variations offered by different platforms include:
Classroom training: this program reduces the amount of time spent out of office or work by the staffs. In this program, the trainers come down to the company's facility to train the staffs. This reduces the amount of time the staffs will spend traveling, as well as the travel expenses. This increases the staffs competence and improves their job performance while at work.
Online training: this is a convenient and self-paced electronic based training program that makes use of different adult learning techniques that enables the students (organization's staffs) to fully understand what has been taught. This makes it easy for them to apply what they are learning on the job. This program makes use of different online platforms that ensures interaction between the lecturers and the students. For comprehensive online training, consider courses like the Clinical Research Coordinator, Pharmacovigilance Certification, and ICH-GCP from CCRPS.
Custom program: this program allows the team of trainers to work with the organization's staffs in order to develop online and offline training programs that are tailored to meet the needs and specifications of the organization and its staffs.
Boot camp and onboarding program: programs like these are most usually for clinical research associates and clinical research coordinators. The onboarding program is ideal for new CRAs. It is a unique intensive training program that can be customized to meet the company's needs. These programs allows the new CRAs and CRCs to make immediate impact and saves the organization more time and money. Specialized training for CRAs and CRCs can be found through the CRA Training and Clinical Trials Assistant Training at CCRPS.
Take courses from CCRPS and learn more about how to become a clinical research professional. Advanced certifications such as the Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification can significantly enhance the expertise and capabilities of your team. Additionally, for those in more specific roles, the Medical Monitor Certification is also available.
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Top 4 Clinical Research Books You Need To Read
With scientific discoveries and technological advancements comes knowledge. This knowledge defines the scope and practices of the different fields of professions that they apply to. Due to the continuous nature of medical research, the medical sciences are not also behind on scientific discoveries. More often than not, there is a new field knowledge that changes the way people do their job. The change could be something in something routine as checking the blood pressure of a patient or measuring the body temperature. A smart clinical research scientist knows that they have to ensure that they stay up to date with scientific discoveries to help patients as well as themselves.
If you have been offered a clinical research job or you are interested in one, one thing you should know for sure is that to be successful in this field, you need to know your stuff. It is true what they say, to remain relevant in any field is to remain knowledgeable.
To help your cause, we have made a list of 6 books that will help you succeed in the clinical research field.
Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David DeMets. This book looks into key issues like assessment, reporting of results, randomization, interpretation etc. This book introduces clinical trials to you beautifully, with real life examples used to explain key features of clinical trial.
Designing Clinical Research, by Dr. Stephen B Hulley, MD, MPH, Steven R Cummings, MD, Warren S Browner, MD. This book is an important book for doctors, pharmacists, nurses and all medical professionals involved in medical research. It explains useful methods for designing, funding and implementing clinical research.
Publishing and Presenting Clinical Research, Third Edition, by Warren S. Browner MD. This book contains the essentials of clinical trials and publication. This book will come in handy for those who wants to know more about organizing, delivering, and publishing the results of their research in the best way possible.
Practical Guide to Clinical Data Management, Third Edition, by Susanne Prokscha. One issue that always pops up in clinical research is how to manage the large volumes of ever increasing data. If you are already working in the field, you could no doubt relate. This is a task that can be rightfully described as “extremely time consuming”. This book gives powerful insights on current industry tactics on the use of Electronic Data Capture (EDC) for clinical research. This book will help you solve the age-long problem of managing voluminous clinical research data.
Honorable mentions
Basic Principles of Clinical Research and Methodology by S. K. Gupta
A Clinical Trial Manual from the Duke Clinical Research Institute. Kate Davis, Margaret Liu.
We have introduced many good reads for those who like to stay informed. Whether you are someone looking to get started in the field or someone who is looking for a refresher, these are the perfect places to start. If you need motivation to get reading, here are some clinical research positions to remind you of what is possible when you apply yourself.
If you prefer online classes with professional guidance, check out CCRPS’ certification courses. They offer one of the only major ACCRE accredited courses in the US. The courses are created by real, senior professionals who skip the nonsense and get right into what you need to succeed in the field.
To learn more about the role of a Clinical Research Coordinator, consider this Clinical Research Coordinator course.
Explore the realm of drug safety with our Pharmacovigilance Certification.
Dive into clinical research specifics with the CRA certification.
Understand the essential regulations with the ICH-GCP course.
Begin your journey in clinical trials with the Clinical Trials Assistant Training.
Enhance your skills with the Advanced Clinical Research Project Manager Certification.
For physicians aiming at leading research, consider the Advanced Principal Investigator Physician Certification.
Specialize in monitoring clinical trials with the Medical Monitor Certification.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Trial Monitoring Reports and How to Write Them
Among the aspects in study is observation. Overseeing the advancement of any stage, measure, process, and procedure in real time is essential to the accurate conclusion of any clinical trial undertaking. Normal monitoring actions are needed to guarantee caliber , efficiency, compliance with predefined and regulations fundamentals, in addition to comprehensiveness, and precision within clinical investigation. Such actions also ensure that the trial isn't just conducted in compliance with Standard Operating Procedures (SOPs) however they also function to validate it is correctly reported and recorded. There is something with a part in the execution of trials. And this thing is known as trial development reports.
Such a report ought to be carefully prepared and it must summarize the means that a study is done. It also ought to point out recruiting progress and procedures; should emphasize and clarify adjustments to the analysis, and ought to point security issues if there are not some.
Aside from the ethics committee, researchers could also be necessary to present yearly improvement reports of an investigation (such as any applicable alterations or dangers ) to spouses, encouraging associations, and/or organizations, along with other interested parties if needed.
If you're thinking about getting important skills on GCP or you also would like to upgrade your own know-how, subscribe to our comprehensive Great Clinical Practice class here.
In summary, tracking and reporting processes have an incredibly significant function in clinical trials. The right behaviour of these procedures not merely ensures compliance with legislation, regulations, and predetermined conditions, but in addition, it makes certain the study doesn't pose any dangers to their wellbeing. Progress reports, subsequently, empower practitioners, specialists, researchers, ethics committees, as well as others involved to keep a tab on the trial and its own advancement. They may signal any alterations or risks and may, therefore, react to them timely, correctly, and efficiently.
The objective of progress reports would be to accumulate and outline upgrades, key facets, along with summaries of a continuing trial. It's very crucial to be aware that progress reports must be filed to institutional evaluation board/independent integrity questionnaire (IRB/IEC), following a trial has obtained positive opinion.
One other important issue to mention is there are many different forms as soon as it comes to submitting progress reports that researchers must take into consideration before proceeding. Precisely, these kinds are:
Printing name and date of entry ought to be composed also. A digital copy is also needed to be delivered to the interested websites and committees inside a 30-day interval following the reporting procedure was completed.
The period of time whereby an advance report ought to be filed is at least one time in a year. Nevertheless, based upon the situation as well as the RECs' needs, these reports might be passed in more often, although the analysis is still going and till its official conclusion date.
Among the most important aspects of study is observation. Overseeing the advancement of any stage, measure, process, and procedure in real time is essential to the accurate conclusion of any clinical trial undertaking. Normal monitoring actions are needed to guarantee caliber, efficiency, compliance within predefined and regulations fundamentals. In addition, it guarantees comprehensiveness, and precision within clinical investigation. Such actions also ensure that the trial isn't just conducted in compliance with Standard Operating Procedures (SOPs). They must also function to validate it is correctly reported and recorded. Consider enrolling in the Clinical Research Coordinator course or the CRA training provided by CCRPS.
There demands something vital as a part in the execution of trials. And this thing is known as trial development reports.
Such a report ought to be carefully prepared and it must summarize the means that a study is done. It also ought to point out recruiting progress and procedures; should emphasize and clarify adjustments to the analysis, and ought to point security issues. If you're involved in such reporting or need an in-depth understanding of the procedures, the Advanced Clinical Research Project Manager Certification might be of interest.
Aside from the ethics committee, researchers could also need to present yearly improvement reports of an investigation (such as any applicable alterations or dangers) to spouses, encouraging associations, and/or organizations, along with other interested parties if needed. To understand more about these requirements and get certified, the ICH-GCP course is an excellent resource.
If you're thinking about getting important skills on GCP or you also would like to upgrade your own know-how, subscribe to our comprehensive Good Clinical Practice class here.
In summary, tracking and reporting processes is an incredibly significant function in clinical trials. The right conduct of these procedures ensure compliance with legislation, regulations, and predetermined conditions. In addition, they make certain that the study doesn't pose any dangers to wellbeing. Progress reports, subsequently, empower practitioners, specialists, researchers, ethics committees, as well as others involved to keep a tab on the trial and its own advancement. Clinical professionals need to signal any alterations or risks to react to them timely, correctly, and efficiently. For further training, consider the Pharmacovigilance Certification to deepen your knowledge in monitoring drug safety.
The objective of progress reports would be to accumulate and outline upgrades, key facets, along with summaries of a continuing trial. It's very crucial to be aware that progress reports must be filed to institutional evaluation board/independent integrity questionnaire (IRB/IEC), following a trial that has obtained positive opinion.
One other important issue to mention is there are many different forms and when it comes to submitting progress reports that researchers must take into consideration before proceeding.
Precisely, these kinds are:
Printing name and date of entry ought to be composed also. A digital copy is also needed to be delivered to the interested websites and committees inside a 30-day interval following the reporting procedure was completed.
The period of time whereby an advance report ought to be filed is at least one time in a year. Nevertheless, based upon the situation as well as the RECs' needs, these reports might be passed in more often, although the analysis is still going and till its official conclusion date.
Take courses from CCRPS and learn more on how to become a clinical research professional. For detailed guidance on submission requirements and processes, the Medical Monitor Certification and Advanced Principal Investigator Physician Certification can provide extensive knowledge.
Discover more from Clinical Trials Assistant Training | Clinical Research Training | Certified Clinical Research Professionals Course to further your career in clinical research management.
