Covid 19 Clinical Trials

The coronavirus disease 2019 (COVID-19) viral pneumonia is now a worldwide pandemic caused by the Severe acute respiratory virus coronavirus 2 (SARS-CoV-2). The number of cases, and associated mortality has increased dramatically since the first cases in Wuhan, China in December 2019 . To date, no specific treatment has been proven to be effective for COVID-19. Treatment is currently mainly supportive, with in particular mechanical ventilation for the critically ill patients (6.1% in a series of 1099 cases in China). Novel therapeutic approaches are in acute need. In this context, the therapeutic potential associated with convalescent plasma needs to be explored. The objective of COVIPLASM trial (a nested trial in the CORIMUNO-19 COHORT) is to study the efficacy of convalescent plasma to treat SARS-COV2 infected patients.

NCT04345991 Covid19 Drug: Transfusion of COVID-19 convalescent plasma

Primary Outcomes

Description: Survival without needs of ventilator utilization (including non- invasive ventilation, NIV) or use of immunomodulatory drugs at day 14 of randomization (WHO score < 6). Thus, events considered are the need of ventilator use (including non invasive ventilation, NIV, or use of immunomodulatory drugs), or death.

Measure: Survival without needs of ventilator utilization or use of immunomodulatory drugs

Time: At day 14 after randomization

Description: WHO progression scale ≥6 at day 4 of randomization

Measure: WHO progression scale ≥6

Time: at day 4 of randomization

Secondary Outcomes

Description: Occurrence of severe adverse events known to be associated with plasma transfusion such as transfusion associated circulatory overload (TACO), transfusion related acute lung injury (TRALI), and severe allergy will be reported. Occurrence of systemic and/or local (lungs) inflammation associated with convalescent plasma transfusion will also be reported.

Measure: Severe adverse events

Time: up to 28 days

Description: WHO progression scale at 4, 7 and 14 days after randomization (from stage 4-5 to stage 6 to 10) Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale

Time: at 4, 7 and 14 days after randomization

Measure: Overall survival

Time: at 14 and 28 days after randomization

Measure: Time from randomization to discharge

Time: Time until discharge up to 28 days

Measure: Time to oxygen supply independency

Time: Time until oxygen supply independency up to 28 days

Description: Survival without needs of ventilator utilization (including non- invasive ventilation, NIV) at day 14 of randomization (WHO score < 6). Thus, events considered are the need of ventilator use (including non invasive ventilation, NIV), or death.

Measure: Survival without needs of ventilator utilization

Time: At day 14 after randomization

Description: Survival without use of immunomodulatory drugs at day 14 of randomization (WHO score < 6). Thus, events considered are use of immunomodulatory drugs, or death.

Measure: Survival without use of immunomodulatory drugs

Time: At day 14 after randomization

CovidResearchTrials by Shray Alag

Covid 19 Research using Clinical Trials (Home Page)

Transfusion of COVID-19 convalescent plasmaWiki

Developed by Shray Alag

Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Correlated MeSH Terms (3)

Correlated HPO Terms (1)

Clinical Trials

1 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - CORIMUNO-CORIPLASM : EFFICACY OF CONVALESCENT PLASMA TO TREAT SARS-COV2 INFECTED PATIENTS

NCT04345991 Covid19 Drug: Transfusion of COVID-19 convalescent plasma

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)