CCRPS Clinical Research Taininrg

View Original

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

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

See this gallery in the original post