CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (34)


Name (Synonyms) Correlation
drug627 Leronlimab (700mg) Wiki 0.35
drug1390 samling of oropharynx and nasopharynx Wiki 0.25
drug1119 TD-0903 Wiki 0.25
drug81 ArtemiC Wiki 0.25
drug387 ECG-Holter Wiki 0.25
drug1181 Treatment and prophylaxis Wiki 0.25
drug148 Best Supportive Care Wiki 0.25
drug615 Ivermectine Wiki 0.25
drug684 Measles-Mumps-Rubella Vaccine Wiki 0.25
drug593 Interleukin-7 Wiki 0.25
drug750 Nigella Sativa / Black Cumin Wiki 0.25
drug1308 global survey Wiki 0.25
drug1330 lopinavir/ritonavir Wiki 0.25
drug1058 Standard Public Health measures Wiki 0.25
drug64 Angiotensin 1-7 Wiki 0.25
drug242 Canakinumab Injection 300mg Wiki 0.25
drug243 Canakinumab Injection 600mg Wiki 0.25
drug945 Ravulizumab Wiki 0.25
drug1382 questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality Wiki 0.25
drug494 Honey Wiki 0.25
drug111 Azithromycin 500 mg Wiki 0.25
drug683 Mavrilimumab Wiki 0.18
drug365 Dexamethasone injection Wiki 0.18
drug741 Nasopharyngeal swab Wiki 0.18
drug467 HB-adMSCs Wiki 0.18
drug522 Hydroxychloroquine Sulfate Wiki 0.15
drug650 Losartan Wiki 0.09
drug762 No intervention Wiki 0.08
drug431 Favipiravir Wiki 0.08
drug1168 Tocilizumab Wiki 0.06
drug505 Hydroxychloroquine Wiki 0.05
drug865 Placebo oral tablet Wiki 0.05
drug108 Azithromycin Wiki 0.05
drug850 Placebo Wiki 0.04

Correlated MeSH Terms (18)


Name (Synonyms) Correlation
D008457 Measles NIH 0.25
D054969 Primary Dysautonomias NIH 0.25
D008231 Lymphopenia NIH 0.25
D001342 Autonomic Nervous System Diseases NIH 0.25
D011565 Psoriasis NIH 0.25
D055370 Lung Injury NIH 0.13
D003141 Communicable Diseases NIH 0.11
D018352 Coronavirus Infections NIH 0.10
D045169 Severe Acute Respiratory Syndrome NIH 0.09
D007249 Inflammation NIH 0.08
D011014 Pneumonia NIH 0.07
D011024 Pneumonia, Viral NIH 0.07
D007239 Infection NIH 0.07
D055371 Acute Lung Injury NIH 0.07
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D016638 Critical Illness NIH 0.05
D013577 Syndrome NIH 0.03
D012127 Respiratory Distress Syndrome, Newborn NIH 0.03

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0003765 Psoriasiform dermatitis HPO 0.25
HP:0001888 Lymphopenia HPO 0.25
HP:0002090 Pneumonia HPO 0.07

There are 16 clinical trials

Clinical Trials


1 Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV-2 In a Pragmatic aDaptive randoMizED Clinical Trial During the COVID-19 Pandemic (COVID MED Trial)

Although a number of therapeutics are being utilized by clinicians to treat patients with COVID-19, none have been systematically evaluated in clinical trials. Lopinavir/ritonavir, an antiretroviral medication, showed equivocal but possibly positive efficacy and safety in a RCT conducted in China and published in NEJM in March of 2020. Hydroxychloroquine, an antimalarial and anti-inflammatory medication, has shown potent antiviral activity in vitro and elimination of viral shedding in a small pilot clinical trial. Losartan, an angiotensin II receptor blocker (ARB), has theoretical benefit as SARSCoV-2 appears to bind to lung tissue via Angiotensin-Converting Enzyme 2 (ACE-2) receptors which might be inhibited by ARBs. This pragmatic adaptive trial compares outcome in COVID-19 patients treated with lopinavir/ritonavir, hydroxychloroquine, losartan, and placebo.

NCT04328012 SARS-CoV-2 Infection Drug: lopinavir/ritonavir Drug: Hydroxychloroquine Sulfate Drug: Losartan Drug: Placebos

Primary Outcomes

Description: difference in NCOSS scores between the different treatment groups

Measure: National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS)

Time: 60 days

Secondary Outcomes

Description: difference in the total inpatient LOS between the four treatment groups

Measure: Hospital length of stay (LOS)

Time: 60 days

Description: difference in the total ICU level care LOS between the four treatment groups

Measure: Intensive care unit level LOS

Time: 60 days

Description: difference in length of use of mechanical ventilation between the four treatment groups

Measure: Mechanical ventilation

Time: 60 days

Description: difference in all cause mortality between the four treatment groups

Measure: survival

Time: 60 days

2 Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Unicentric, Double-Blinded Randomized Controlled Trial

The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.

NCT04331834 COVID-19 Drug: Hydroxychloroquine Drug: Placebos

Primary Outcomes

Description: Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 at day 0.

Measure: Confirmed cases of a COVID-19

Time: Up to 6 months after start of treatment

Secondary Outcomes

Description: SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.

Measure: SARS-CoV-2 seroconversion

Time: Up to 6 months after start of treatment

Description: Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.

Measure: Occurrence of any adverse event related with hydroxychloroquine treatment

Time: Up to 6 months after start of treatment

Description: Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.

Measure: Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers

Time: Up to 6 months after start of treatment

Measure: Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19

Time: Up to 6 months after start of treatment

Description: A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.

Measure: COVID-19 Biobank

Time: Up to 6 months after start of treatment

3 Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19

This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.

NCT04332107 COVID-19 SARS-CoV-2 Drug: Azithromycin Drug: Placebos

Primary Outcomes

Description: All-cause hospitalization or emergency room stay of >24 hours

Measure: Hospitalization

Time: 14 days

Secondary Outcomes

Description: Viral load by self-collected nasal swab

Measure: Viral load

Time: 3 days

Description: Viral load by self-collected saliva swab

Measure: Viral load

Time: 3 days

Description: All-cause mortality

Measure: Mortality

Time: 14 days

Description: Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash

Measure: Adverse events

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected nasal swab

Measure: Positive SARS-CoV-2 test - nasal swab

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected saliva swab

Measure: Positive SARS-CoV-2 test - saliva swab

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected rectal swab

Measure: Positive SARS-CoV-2 test - rectal swab

Time: 3 days

Description: Prevalence of genetic macrolide resistance determinants by self-collected rectal swab

Measure: Genetic macrolide resistance determinants

Time: 3 days

Description: Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms

Measure: COVID-19 symptoms

Time: 3, 7, 14, 21 days

Description: Number of emergency room visits <24 hours

Measure: Number of emergency room visits

Time: 14 days

Description: Number of household members with confirmed or symptomatic COVID-19

Measure: Number of household members with COVID-19 (confirmed or symptomatic)

Time: 14 days

Description: Deaths within the study will be attempted to be matched with the US National Death Index

Measure: Death

Time: 21 days

4 Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial

Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.

NCT04332666 Coronavirus Respiratory Failure Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere SARS-CoV-2 Drug: Angiotensin 1-7 Drug: Placebos
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: composite outcome of mortality and necessity of mechanical ventilation

Measure: ventilator free days

Time: 28 days

Secondary Outcomes

Description: number of days free from intensive care unit

Measure: ICU free days

Time: trough study completion, on average 40 days

Description: Hospital length of stay

Measure: Hospital length of stay

Time: through study completion, on average 60 days

Description: Time to wean from mechanical ventilation

Measure: Time to wean from mechanical ventilation

Time: through study completion, on average 14 days

Description: PaO2/FiO2 changes during drug administration

Measure: PaO2/FiO2 changes during drug administration

Time: 48 hours

Description: US confirmed deep vein thrombosis

Measure: Deep vein thrombosis incidence

Time: through study completion, on average 30 days

Description: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gamma

Measure: Changes in inflammatory markers

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Ang II and Ang-(1-7) plasmatic levels

Measure: RAS effectors levels

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Chest x-ray or CT scan changes

Measure: Radiological findings

Time: through study completion, on average 30 days

Other Outcomes

Description: phase 2b = principal safety outcome; phase 3 = secondary outcome

Measure: Rate of serious adverse events

Time: study drug administration/day 28 or ICU discharge or death

5 Adjuvant Use of Ivermectin To Hydroxychloroquine and Azithromycin in Patients With Covid19: A Novel Double Blind Placebo Controlled Pilot Study

Comparing the efficacy and safety of adjuvant use of Ivermectin in covid19 patients with pneumonia using Ivermectin with hydroxychloroquine compared to HCQ

NCT04343092 COVID 19 Drug: Ivermectine Drug: Hydroxychloroquine Sulfate Drug: Placebos Drug: Azithromycin 500 mg

Primary Outcomes

Description: Number of patients cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for covid19 (PCR) in addtion to Chest xary

Measure: Number of cured patients

Time: 2 weeks

Secondary Outcomes

Description: Adverse events are assessed by Complete blood count (CBC), Liver function tests (ALT, AST),Renal function tests (blood urea, serum creatinine) and Fasting blood sugar test

Measure: Number of participants with treatment-related adverse events

Time: 2 weeks

6 A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

NCT04343651 Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg)
MeSH:Coronavirus Infections

Primary Outcomes

Description: Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.

Measure: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)

Time: Day 14

Secondary Outcomes

Measure: Time to clinical resolution (TTCR)

Time: Day 14

Description: This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.

Measure: Change from baseline in National Early Warning Score 2 (NEWS2)

Time: Days 3, 7, and 14

Measure: Change from baseline in pulse oxygen saturation (SpO2)

Time: Days 3, 7, and 14

Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.

Measure: Change from baseline in the patient's health status on a 7-category ordinal scale

Time: Days 3, 7, and 14

Measure: Incidence of hospitalization

Time: Day 14

Measure: Duration (days) of hospitalization

Time: Day 14

Measure: Incidence of mechanical ventilation supply

Time: Day 14

Measure: Duration (days) of mechanical ventilation supply

Time: Day 14

Measure: Incidence of oxygen use

Time: Day 14

Measure: Duration (days) of oxygen use

Time: Day 14

Measure: Mortality rate

Time: Day 14

Measure: Time to return to normal activity

Time: Day 14

Other Outcomes

Measure: Change in size of lesion area by chest radiograph or CT

Time: Day 14

Measure: Change from baseline in serum cytokine and chemokine levels

Time: Days 3, 7, and 14

Measure: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages

Time: Days 3, 7, and 14

Measure: Change from baseline in CD3+, CD4+ and CD8+ T cell count

Time: Days 3, 7, and 14

7 A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

NCT04347239 Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg)
MeSH:Coronavirus Infections

Primary Outcomes

Description: Day 0 refers to the data of randomization/first treatment.

Measure: All-cause mortality at Day 28

Time: Day 28

Secondary Outcomes

Description: Day 0 refers to the data of randomization/first treatment.

Measure: All-cause mortality at Day 14

Time: Day 14

Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Change in clinical status of subject at Day 14 (on a 7 point ordinal scale)

Time: Day 14

Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)

Time: Day 28

Description: The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine

Measure: Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

Time: Day 14

8 The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Lahore, Pakistan

To evaluate the effectiveness of Nigella Sativa/ Black Cummins (1gm seed powder in a capsule orally) and 30ml of honey stirred in 250ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care vs standard hospital care alone with placebo capsule and 250ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).

NCT04347382 Coronavirus Infection Sars-CoV2 Drug: Honey Drug: Nigella Sativa / Black Cumin Drug: Placebos
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: RT-PCR will be done on admission day (0 day) and then after every 4th day for 14 days or till the symptoms resolved and RT-PCR gets negative. RT-PCR will only be shown as positive or negative (as per limitation of Pakistan).

Measure: Days required to get a positive COVID-19 PCR to negative

Time: upto max 14 days

Description: HRCT will be conducted at admission day (0-day) and a total of maximum four CT-scan will be conducted after every 4th day. The minimum and score at which we label covid-19 positive will be 5 and 25 respectively using internationally standard nomenclature as described by Fleischner Society glossary and peer-reviewed literature on viral pneumonia.

Measure: HRCT/ X-ray findings of disease progression

Time: upto max 14 days

Description: Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.

Measure: Severity of symptoms progression

Time: upto max 14 days

Description: Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.

Measure: Duration of Hospital Saty

Time: upto max 14 day

Description: 30 days mortality rate in each arm

Measure: 30 day mortality

Time: 30 days

Secondary Outcomes

Description: every 4th day oxygen saturation at room air will be checked to evaluate the disease progression

Measure: Oxygen Saturation at room air

Time: upto max of 14 days

Description: Involvement of cardiac complications will be assessed

Measure: Incidence of viral myocarditis

Time: upto max 14 days

Description: Lethal complication like ARDS will be assessed to evaluate disease severity

Measure: Incidence of Acute respiratory Distress Syndrome

Time: upto max 14 days

9 A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19

Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.

NCT04348435 COVID-19 Drug: HB-adMSCs Drug: Placebos

Primary Outcomes

Description: Number of subjects that must be hospitalized for COVID-19 during the conduct of this study

Measure: Incidence of hospitalization for COVID-19

Time: week 0 through week 26 (end of study)

Description: Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough.

Measure: Incidence of symptoms associated with COVID-19

Time: week 0 through week 26 (end of study)

Secondary Outcomes

Description: Number of subjects that develop upper/lower respiratory infection with hospitalization criteria

Measure: Absence of upper/lower respiratory infection

Time: week 0 through week 26

Description: change from baseline in leukocyte differential

Measure: Leukocyte differential

Time: weeks 0, 6, 14, 26

Description: change from baseline in C Reactive protein

Measure: C Reactive protein

Time: weeks 0, 6, 14, 26

Description: change from baseline in TNF alpha

Measure: TNF alpha

Time: weeks 0, 6, 14, 26

Description: change from baseline in IL-6

Measure: IL-6

Time: weeks 0, 6, 14, 26

Description: change from baseline in IL-10

Measure: IL-10

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of glucose in the blood (mg/dL)

Measure: Glucose

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of calcium in the blood (mg/dL)

Measure: Calcium

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of albumin in the blood (g/dL)

Measure: Albumin

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of total protein in the blood (g/dL)

Measure: Total protein

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of sodium in the blood (mol/L)

Measure: Sodium

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of total carbon dioxide in the blood (mmol/L)

Measure: Total carbon dioxide

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of potassium in the blood (mmol/L)

Measure: Potassium

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of chloride in the blood (mmol/L)

Measure: Chloride

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of BUN in the blood (mg/dL)

Measure: BUN

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of creatinine in the blood (mg/dL)

Measure: Creatinine

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)

Measure: Alkaline phosphatase

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)

Measure: Alanine aminotransferase

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of total bilirubin in the blood (mg/dL)

Measure: Total bilirubin

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of white blood cells in the blood (x 10^3/uL)

Measure: white blood cells

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of red blood cells in the blood (x 10^6/uL)

Measure: red blood cells

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of hemoglobin in the blood (g/dL)

Measure: hemoglobin

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of level of hematocrit in the blood (%)

Measure: hematocrit

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of mean corpuscular volume in the blood (fL)

Measure: mean corpuscular volume

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)

Measure: mean corpuscular hemoglobin

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of mean corpuscular hemoglobin concentration in the blood (g/dL)

Measure: mean corpuscular hemoglobin concentration

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of red cell distribution width in the blood (%)

Measure: red cell distribution width

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of neutrophils in the blood (%)

Measure: neutrophils

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of lymphocytes in the blood (%)

Measure: Lymphs

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of monocytes in the blood (%)

Measure: Monocytes

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of eosinophils in the blood (%)

Measure: Eosinophils

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of basophils in the blood (%)

Measure: Basophils

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)

Measure: Absolute neutrophils

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of absolute lymphocytes in the blood (x 10^3/uL)

Measure: Absolute lymphs

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)

Measure: Absolute monocytes

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)

Measure: Absolute eosinophils

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)

Measure: Absolute basophils

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of immature granulocytes in the blood (x 10^3/uL)

Measure: Immature granulocytes

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of platelets in the blood (x 10^3/uL)

Measure: Platelets

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of time for blood to coagulate (seconds)

Measure: Prothrombin time

Time: weeks 0, 6, 14, 26

Description: clinical lab evaluation of international normalized ratio of blood coagulation (no unit)

Measure: INR

Time: weeks 0, 6, 14, 26

Description: Short-form 36 Health Survey; scored on a scale of 0-100; lower score equals more disability

Measure: SF-36

Time: weeks 0, 6, 14, 26

Description: Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression

Measure: PHQ-9

Time: weeks 0, 6, 14, 26

10 Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment

Faviprevir in COVID-19 treatment

NCT04351295 COVID Drug: Favipiravir Drug: Placebos

Primary Outcomes

Description: The total number of patients with viral cure

Measure: Number of patients with viral cure

Time: 6 months

11 Tocilizumab to Prevent the Progression of Hypoxemic Respiratory Failure in Hospitalized Non-Critically Ill Patients With COVID-19

This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation. Participants will complete screening procedures, where inclusion and exclusion criteria will be evaluated. After screening, participants who meet all inclusion criteria and none of the exclusion criteria will be randomized 2:1 to tocilizumab or placebo. Participants will be followed for safety for 28 days after the last dose of study drug. We anticipate enrolling between 300 patients admitted to Massachusetts General Hospital (and additional Partners sites, after approval, including BWH, NSMC, and the NWH) into the trial.

NCT04356937 SARS-CoV 2 Drug: Tocilizumab Drug: Placebos

Primary Outcomes

Description: tocilizumab can decrease progression of COVID-19 associated respiratory failure necessitating ICU admission.

Measure: Proportion of patients that require mechanical ventilation

Time: 28 days

Secondary Outcomes

Measure: Requirement for inotropes and/or vasopressors

Time: 28 days

Description: Assessed at day 7, 14, 28 or day of discharge.Defined as moving up 2 levels on the following scale

Measure: 8-level Clinical improvement Scale

Time: 28 days

Measure: Duration of mechanical ventalition

Time: 28 days

Description: Time to hospital discharge

Measure: Hospital discharge

Time: 28 days

Description: Mortality at day 7, 14 and 28

Measure: Mortality

Time: 28 days

Description: Duration of ICU stay (up to Day 28)

Measure: Duration of ICU stay

Time: 28 days

Measure: Duration of time on supplemental oxygen

Time: 28 days

Description: The proportion of patients who require renal replacement therapy or have doubling of creatinine from baseline at Day 14 and Day 28

Measure: The proportion of patients who require renal replacement therapy or have doubling of creatinine

Time: 28 days

12 Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)

Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that cross-protective antibodies against measles vaccine ( MV). In mice susceptible to measles virus, recombinant MV induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with SARS-CoV, The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19. We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness

NCT04357028 Covid19 Drug: Measles-Mumps-Rubella Vaccine Drug: Placebos
MeSH:Measles

Primary Outcomes

Description: Number of participants with asymptomatic or mild COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)

Measure: COVID-19 disease incidence

Time: Time Frame: Measured over the 6 months following randomization

Secondary Outcomes

Description: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: SARS-CoV-2 pneumonia

Time: Time Frame: Measured over the 6 months following randomization

Description: Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Critical care admission duration with SARS-CoV-2

Time: Time Frame: Measured over the 6 months following randomization

Description: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Oxygen therapy with SARS-CoV-2

Time: Time Frame: Measured over the 6 months following randomization

13 Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial

This trial will determine the safety and estimate efficacy of targeted corticosteroids in mechanically ventilated patients with the hyper-inflammatory sub phenotype of ARDS due to coronavirus disease 2019 (COVID-19) by implementing a Phase 2A clinical trial.

NCT04360876 COVID-19 ARDS Drug: Dexamethasone injection Drug: Placebos
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Total number of ventilator free days to day 28 of hospitalization. If a patient dies prior to day 28, they will be counted as zero ventilator free days. Follow up will be performed via phone or electronically to determine ventilator free status of those patients discharged prior to day 28.

Measure: Ventilator Free Days (VFD) at Day 28

Time: 28 Days

Secondary Outcomes

Description: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.

Measure: Clinical Status at day 14 as measured by World Health Organization (WHO) 7-point ordinal scale.

Time: 14 Days

Measure: Clinical Status at day 28 as measured by WHO 7-point ordinal scale

Time: 28 Days

Measure: In-Hospital Mortality at day 28

Time: 28 Days

Measure: In-Hospital Mortality at day 90

Time: 90 Days

Measure: Time to Mortality to day 28

Time: 28 Days

Measure: ICU-free days to day 28

Time: 28 Days

Measure: Hospital Length of Stay among survivors to day 90

Time: 90 Days

Measure: Severity of ARDS to day 10

Time: 10 Days

Measure: Days to resolution of fever

Time: 28 Days

Measure: Change in C-Reactive Protein (CRP) level from baseline to day 10

Time: 10 Days

Measure: Vasopressor-free days to day 28

Time: 28 Days

Measure: Renal replacement-free days to day 28

Time: 28 Days

Measure: Duration of mechanical ventilation to day 28

Time: 28 Days

Measure: Oxygenation-free days to day 28

Time: 28 Days

Measure: Incidence of New Mechanical Ventilation to day 28

Time: 28 Days

Measure: Change in sequential organ failure assessment (SOFA) score from baseline to day 10

Time: 10 Days

Measure: In-hospital adverse events to day 28

Time: 28 Days

Measure: Discontinuation of study drug infusion

Time: 10 Days

14 Canakinumab to Reduce Deterioration of Cardiac and Respiratory Function in SARSCoV2 Associated Acute Myocardial Injury and Hyperinflammation

TThe purpose of this prospective, Phase 2, single center, blinded, randomized controlled study is to demonstrate as a proof of concept that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID-19 infection. These results will lead to and inform a Phase III randomized placebo-controlled trial.

NCT04365153 COVID-19 SARS-CoV 2 Drug: Canakinumab Injection 600mg Drug: Canakinumab Injection 300mg Drug: Placebos

Primary Outcomes

Description: Number of days

Measure: Time to clinical improvement up to day 14, defined as the time in days from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever occurs first.

Time: Up to day 14

Secondary Outcomes

Description: Number of days

Measure: Mortality at day 28

Time: Up to day 28

15 A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in UK

Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.

NCT04379076 COVID-19 Lymphocytopenia Drug: Interleukin-7 Drug: Placebos
MeSH:Lymphopenia
HPO:Lymphopenia

Primary Outcomes

Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge

Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whicheve

Time: 1 month

Secondary Outcomes

Description: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score

Measure: To obtain "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD.

Time: 1 month

Description: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)

Measure: determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD

Time: one month

Description: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45

Measure: To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45

Time: 45 days

Description: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)

Measure: To compare the effect of CYT107 versus placebo on the length of hospitalization

Time: 45 days

Description: Number of days in ICU during index hospitalization

Measure: To compare the effect of CYT107 versus placebo on the length of stay in ICU

Time: 45 days

Description: Readmissions to ICU through Day 45

Measure: To compare the effect of CYT107 versus placebo on readmissions to ICU

Time: 45 days

Description: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)

Measure: To compare the effect of CYT107 versus placebo on organ support free days

Time: 45 days

Description: Number of readmissions to the hospital through Day 45

Measure: To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45

Time: 45 days

Description: All-cause mortality through Day 45

Measure: To assess the impact of CYT107 on all-cause mortality through day 45

Time: 45 days

Description: Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD

Measure: To determine the effect of CYT107 on CD4+ and CD8+ T cell counts

Time: 30 days

Description: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30

Measure: To track and evaluate other known biomarkers of inflammation: Ferritin

Time: 30 days

Description: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30

Measure: To track and evaluate other known biomarkers of inflammation: CRP

Time: 30 days

Description: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30

Measure: To track and evaluate other known biomarkers of inflammation: D-dimer

Time: 30 days

Description: Evaluate improvement of the NEWS2 score value

Measure: Evaluation of physiological status through NEWS2 score

Time: 30 days

Other Outcomes

Description: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)

Measure: Safety assessment

Time: 45 days

16 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation

The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

NCT04399980 COVID 19 SARS-CoV 2 Pneumonia Drug: Mavrilimumab Drug: Placebos
MeSH:Pneumonia Respiratory Insufficiency Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Number of subjects alive and off of oxygen

Measure: Proportion of subjects alive and off of oxygen at day 14

Time: Day 14

Secondary Outcomes

Description: Number of subjects alive and without respiratory failure

Measure: Proportion of subjects alive and without respiratory failure at 28 days

Time: Day 28


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