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.
During SARS-CoV-2 infection, two clinical-biological phases can be observed: an initial viral phase followed by an immunological phase whose onset has been associated with more severe prognosis. Hospitalized patients with comorbidities or clinical risk factors have a higher risk of respiratory functions deterioration and significant risk to need intensive care. Early transfusion of convalescent plasma (2 units of 200-230 mL of apheresis plasma inactivated by amotosalen) would prevent this secondary worsening and reduce the risk to be transferred to intensive care, length of stay and mortality. Considering clinical and biological manifestations of the disease, including coagulation disorders, endothelial alterations, immunological disorders, it seems interesting to compare this convalescent plasma with a SARS-CoV-2 lacking antibodies plasma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
18
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.
HIA Percy
Clamart, France
HIA Laveran
Marseille, France
HIA Bégin
Saint-Mandé, France
HIA Sainte Anne
Toulon, France
Survival time without needs of a ventilator.
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.
Time frame: Day 30
Morbidity
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.
Time frame: Day 15
Morbidity
Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.
Time frame: Day 30
Mortality
Time frame: Day 30
Length of stay
Time frame: Day 30
Effect on viral pharyngeal specimen clearance
Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.
Time frame: At inclusion and Day 7
Effect on viral blood specimen clearance
Quantitative SARS-CoV2 PCR carried out on blood specimen.
Time frame: At inclusion and Day 7
Effect on hemostasis disorders
Effects on biological hemostasis parameters disorders.
Time frame: At inclusion, Day 1 and every 48 hours
Kinetics of appearance of neutralizing antibodies
Anti-SARS-Cov2 immunoglobulin G/A level and anti-SARS-Cov2 neutralizing antibody levels.
Time frame: At inclusion, Day 7
Transfusion endotheliopathy effect
Evolution of biological endotheliopathy parameters
Time frame: At inclusion, Day 1, Day 7
Transfusion biological Inflammation effect
Evaluation of biological dosages on inflammation effects
Time frame: At inclusion, Day 1, Day 7
Transfusion hemovigilance
Number of transfusion adverse events
Time frame: 30 days
Decrease in the consumption of antibiotics
Time frame: 30 days
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