Covid 19 Research using Clinical Trials (Home Page)
Report for D003289: Convalescence NIH
(Synonyms: Convalescence)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug989 | SARS-CoV-2 non-immune Plasma Wiki | 0.71 |
| drug560 | IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki | 0.71 |
| drug69 | Anti- SARS-CoV-2 Plasma Wiki | 0.71 |
| drug563 | Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki | 0.71 |
| drug1291 | convalescent plasma Wiki | 0.41 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.
NCT04323800 Coronavirus Convalescence Biological: Anti- SARS-CoV-2 Plasma Biological: SARS-CoV-2 non-immune Plasma MeSH:Coronavirus Infections Convalescence
Primary Outcomes
Description: The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following: Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection Not hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2
Measure: Cumulative incidence of composite outcome of disease severity Time: Day 28Secondary Outcomes
Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 0 (baseline).
Measure: Anti-SARS-CoV-2 titers Time: BaselineDescription: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 1.
Measure: Anti-SARS-CoV-2 titers Time: Day 1Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 3.
Measure: Anti-SARS-CoV-2 titers Time: Day 3Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 7.
Measure: Anti-SARS-CoV-2 titers Time: Day 7Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 14.
Measure: Anti-SARS-CoV-2 titers Time: Day 14Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 90.
Measure: Anti-SARS-CoV-2 titers Time: Day 90Description: Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.
Measure: Rates of SARS-CoV-2 PCR positivity Time: Up to day 28Description: Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.
Measure: Duration of SARS-CoV-2 PCR positivity Time: Up to day 28Description: Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28 days.
Measure: Peak quantity levels of SARS-CoV-2 RNA Time: Up to day 28Description: Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28): Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection
Measure: Cumulative incidence of disease severity Time: up to Day 282 DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
NCT04356482 COVID-19 SARS-CoV 2 Convalescence Plasma Doses Biological: convalescent plasma MeSH:Convalescence
Primary Outcomes
Description: no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.
Measure: Clinical improvement Time: day -1 to day +22Description: before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times .
Measure: improvement in tomographic image Time: day -1 to day +12Description: the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient.
Measure: test positivity for COVID-19 Time: day +6 to day +12Description: Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI.
Measure: early and late complications associated to convalescent plasma Time: day 0 to day +30Secondary Outcomes
Description: days of stay at ICU will be evaluated
Measure: days at ICU Time: day 0 to day +30