|drug2958||Transfusion of SARS-CoV-2 Convalescent Plasma. Wiki||1.00|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
COVID-19 (Corona Virus Disease 2019) hospitalized patients evolution is marked by the risk of worsening of the respiratory system during the second week of the disease. To date, treatments are currently being evaluated and none of them have shown to be effective in the care of these patients. The use of convalescent plasma is a passive immunotherapy. It has often been used in respiratory virus epidemic situations (during the 1918 or 2009 influenza pandemic, or during SARS-CoV-1 or MERS-CoV pandemic). Effects reported in literature are in favour of a beneficial impact of transfusion of these plasma without serious adverse effects reported. PlasCoSSA is a randomized, controlled, triple-blinded, parallel clinical trial. This study tests the efficacy of convalescent plasma transfusion therapy in the early care of COVID-19 hospitalized patients outside intensive care units.
Description: Survival time without needs of ventilator, i.e. the time until oxygen supply (patient previously in ambient air), or an increase by more than 6L/min of O2 for more than 24 hours, or the use of non-invasive ventilation, or intubation, or death.Measure: Survival time without needs of a ventilator. Time: Day 30
Description: The percentage of patients i) not hospitalized, without limitation of activities, ii) Not hospitalized, with activity limitation, iii) Hospitalized without oxygen therapy, iv) Hospitalized with oxygen therapy, v) Hospitalized with intensive oxygen therapy or non- invasive ventilation (NIV), vi) Hospitalized and intubated or on extracorporeal membrane oxygenation (ECMO), vii) Dead.Measure: Morbidity Time: Day 15
Description: Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.Measure: Morbidity Time: Day 30
Description: Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.Measure: Effect on viral pharyngeal specimen clearance Time: At inclusion and Day 7
Description: Quantitative SARS-CoV2 PCR carried out on blood specimen.Measure: Effect on viral blood specimen clearance Time: At inclusion and Day 7
Description: Effects on biological hemostasis parameters disorders.Measure: Effect on hemostasis disorders Time: At inclusion, Day 1 and every 48 hours
Description: Anti-SARS-Cov2 immunoglobulin G/A level and anti-SARS-Cov2 neutralizing antibody levels.Measure: Kinetics of appearance of neutralizing antibodies Time: At inclusion, Day 7
Description: Evolution of biological endotheliopathy parametersMeasure: Transfusion endotheliopathy effect Time: At inclusion, Day 1, Day 7
Description: Evaluation of biological dosages on inflammation effectsMeasure: Transfusion biological Inflammation effect Time: At inclusion, Day 1, Day 7
Description: Number of transfusion adverse eventsMeasure: Transfusion hemovigilance Time: 30 days