Covid 19 Research using Clinical Trials (Home Page)
PlacebosWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (28)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug460 | Leronlimab (700mg) Wiki | 0.38 |
| drug890 | Valsartan (Diovan) Wiki | 0.27 |
| drug997 | oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants Wiki | 0.27 |
| drug972 | lopinavir/ritonavir Wiki | 0.27 |
| drug876 | Umbilical Cord Mesenchymal Stem Cells Wiki | 0.27 |
| drug449 | Ivermectine Wiki | 0.27 |
| drug84 | Azithromycin 500 mg Wiki | 0.27 |
| drug173 | Canakinumab Injection 600mg Wiki | 0.27 |
| drug172 | Canakinumab Injection 300mg Wiki | 0.27 |
| drug49 | Angiotensin 1-7 Wiki | 0.27 |
| drug350 | Honey Wiki | 0.27 |
| drug970 | isocaloric/isonutrigenous ONS Wiki | 0.27 |
| drug496 | Measles-Mumps-Rubella Vaccine Wiki | 0.27 |
| drug547 | Nigella Sativa / Black Cumin Wiki | 0.27 |
| drug260 | Dexamethasone injection Wiki | 0.19 |
| drug130 | Blood draw Wiki | 0.19 |
| drug313 | Follow up Wiki | 0.19 |
| drug330 | HB-adMSCs Wiki | 0.19 |
| drug375 | Hydroxychloroquine Sulfate Wiki | 0.17 |
| drug627 | Placebo oral tablet Wiki | 0.12 |
| drug82 | Azithromycin Wiki | 0.11 |
| drug304 | Favipiravir Wiki | 0.11 |
| drug480 | Losartan Wiki | 0.10 |
| drug360 | Hydroxychloroquine Wiki | 0.10 |
| drug771 | Standard of Care Wiki | 0.09 |
| drug691 | Remdesivir Wiki | 0.08 |
| drug854 | Tocilizumab Wiki | 0.07 |
| drug616 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (14)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008457 | Measles NIH | 0.27 |
| D001927 | Brain Diseases NIH | 0.19 |
| D018352 | Coronavirus Infections NIH | 0.13 |
| D003141 | Communicable Diseases NIH | 0.13 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.11 |
| D007239 | Infection NIH | 0.11 |
| D055371 | Acute Lung Injury NIH | 0.09 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
| D012141 | Respiratory Tract Infections NIH | 0.07 |
| D016638 | Critical Illness NIH | 0.07 |
| D014777 | Virus Diseases NIH | 0.06 |
| D013577 | Syndrome NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.02 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 14 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 daysSecondary Outcomes
Description: difference in the total inpatient LOS between the four treatment groups
Measure: Hospital length of stay (LOS) Time: 60 daysDescription: difference in the total ICU level care LOS between the four treatment groups
Measure: Intensive care unit level LOS Time: 60 daysDescription: difference in length of use of mechanical ventilation between the four treatment groups
Measure: Mechanical ventilation Time: 60 daysDescription: difference in all cause mortality between the four treatment groups
Measure: survival Time: 60 days2 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 treatmentSecondary 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 treatmentDescription: 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 treatmentDescription: 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 treatmentMeasure: 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 treatment3 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 daysSecondary Outcomes
Description: Viral load by self-collected nasal swab
Measure: Viral load Time: 3 daysDescription: Viral load by self-collected saliva swab
Measure: Viral load Time: 3 daysDescription: All-cause mortality
Measure: Mortality Time: 14 daysDescription: Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash
Measure: Adverse events Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Measure: Positive SARS-CoV-2 test - nasal swab Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Measure: Positive SARS-CoV-2 test - saliva swab Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Measure: Positive SARS-CoV-2 test - rectal swab Time: 3 daysDescription: Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Measure: Genetic macrolide resistance determinants Time: 3 daysDescription: Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms
Measure: COVID-19 symptoms Time: 3, 7, 14, 21 daysDescription: Number of emergency room visits <24 hours
Measure: Number of emergency room visits Time: 14 daysDescription: Number of household members with confirmed or symptomatic COVID-19
Measure: Number of household members with COVID-19 (confirmed or symptomatic) Time: 14 days4 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 daysSecondary Outcomes
Description: number of days free from intensive care unit
Measure: ICU free days Time: trough study completion, on average 40 daysDescription: Hospital length of stay
Measure: Hospital length of stay Time: through study completion, on average 60 daysDescription: Time to wean from mechanical ventilation
Measure: Time to wean from mechanical ventilation Time: through study completion, on average 14 daysDescription: PaO2/FiO2 changes during drug administration
Measure: PaO2/FiO2 changes during drug administration Time: 48 hoursDescription: US confirmed deep vein thrombosis
Measure: Deep vein thrombosis incidence Time: through study completion, on average 30 daysDescription: 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 randomizationDescription: Ang II and Ang-(1-7) plasmatic levels
Measure: RAS effectors levels Time: at randomization, 48 hours after randomization and 72 hours after randomizationDescription: Chest x-ray or CT scan changes
Measure: Radiological findings Time: through study completion, on average 30 daysOther 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 death5 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 weeksSecondary 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 weeks6 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 14Secondary Outcomes
Measure: Time to clinical resolution (TTCR) Time: Day 14Description: 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 14Measure: 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 14Measure: 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 14Measure: 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 28Secondary Outcomes
Description: Day 0 refers to the data of randomization/first treatment.
Measure: All-cause mortality at Day 14 Time: Day 14Description: 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 14Description: 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 28Description: 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 148 With Uncontroversial Honey And Nigella Sativa (WUHAN) Treatment for Novel Coronavirus Infection; Randomized, Controlled, Investigator Initiated Trial
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:Infection 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 dayDescription: 30 days mortality rate in each arm
Measure: 30 day mortality Time: 30 daysSecondary 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 daysDescription: Involvement of cardiac complications will be assessed
Measure: Incidence of viral myocarditis Time: upto max 14 daysDescription: Lethal complication like ARDS will be assessed to evaluate disease severity
Measure: Incidence of Acute respiratory Distress Syndrome Time: upto max 14 days9 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 26Description: change from baseline in leukocyte differential
Measure: Leukocyte differential Time: weeks 0, 6, 14, 26Description: change from baseline in C Reactive protein
Measure: C Reactive protein Time: weeks 0, 6, 14, 26Description: change from baseline in TNF alpha
Measure: TNF alpha Time: weeks 0, 6, 14, 26Description: change from baseline in IL-6
Measure: IL-6 Time: weeks 0, 6, 14, 26Description: change from baseline in IL-10
Measure: IL-10 Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of glucose in the blood (mg/dL)
Measure: Glucose Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of calcium in the blood (mg/dL)
Measure: Calcium Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of albumin in the blood (g/dL)
Measure: Albumin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of total protein in the blood (g/dL)
Measure: Total protein Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of sodium in the blood (mol/L)
Measure: Sodium Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of total carbon dioxide in the blood (mmol/L)
Measure: Total carbon dioxide Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of potassium in the blood (mmol/L)
Measure: Potassium Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of chloride in the blood (mmol/L)
Measure: Chloride Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of BUN in the blood (mg/dL)
Measure: BUN Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of creatinine in the blood (mg/dL)
Measure: Creatinine Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)
Measure: Alkaline phosphatase Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)
Measure: Alanine aminotransferase Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of total bilirubin in the blood (mg/dL)
Measure: Total bilirubin Time: weeks 0, 6, 14, 26Description: 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, 26Description: 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, 26Description: clinical lab evaluation of level of hemoglobin in the blood (g/dL)
Measure: hemoglobin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of hematocrit in the blood (%)
Measure: hematocrit Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of mean corpuscular volume in the blood (fL)
Measure: mean corpuscular volume Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)
Measure: mean corpuscular hemoglobin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of mean corpuscular hemoglobin concentration in the blood (g/dL)
Measure: mean corpuscular hemoglobin concentration Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of red cell distribution width in the blood (%)
Measure: red cell distribution width Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of neutrophils in the blood (%)
Measure: neutrophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of lymphocytes in the blood (%)
Measure: Lymphs Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of monocytes in the blood (%)
Measure: Monocytes Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of eosinophils in the blood (%)
Measure: Eosinophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of basophils in the blood (%)
Measure: Basophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)
Measure: Absolute neutrophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute lymphocytes in the blood (x 10^3/uL)
Measure: Absolute lymphs Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)
Measure: Absolute monocytes Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)
Measure: Absolute eosinophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)
Measure: Absolute basophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of immature granulocytes in the blood (x 10^3/uL)
Measure: Immature granulocytes Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of platelets in the blood (x 10^3/uL)
Measure: Platelets Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of time for blood to coagulate (seconds)
Measure: Prothrombin time Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of international normalized ratio of blood coagulation (no unit)
Measure: INR Time: weeks 0, 6, 14, 26Description: 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, 26Description: Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression
Measure: PHQ-9 Time: weeks 0, 6, 14, 2610 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 months11 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 daysSecondary Outcomes
Measure: Requirement for inotropes and/or vasopressors Time: 28 daysDescription: 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 daysMeasure: Duration of mechanical ventalition Time: 28 days
Description: Time to hospital discharge
Measure: Hospital discharge Time: 28 daysDescription: Mortality at day 7, 14 and 28
Measure: Mortality Time: 28 daysDescription: Duration of ICU stay (up to Day 28)
Measure: Duration of ICU stay Time: 28 daysMeasure: 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 days12 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 randomizationSecondary 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 randomizationDescription: 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 randomizationDescription: 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 randomization13 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
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 DaysSecondary 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 DaysMeasure: 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
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 14Secondary Outcomes
Description: Number of days
Measure: Mortality at day 28 Time: Up to day 28