Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.
Overview
- Phase
- Phase 3
- Intervention
- Transfusion of SARS-CoV-2 Convalescent Plasma.
- Conditions
- COVID-19
- Sponsor
- Direction Centrale du Service de Santé des Armées
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- Survival time without needs of a ventilator.
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-90 years ;
- •COVID-19 confirmed case ;
- •Cases showing respiratory symptoms, checking at least one of the following criteria:
- •Cough, dyspnea, respiratory rate \> 24 breaths/min
- •Oxygen saturation \< 95% at rest in ambient air
- •PaO2 \< 70mmHg
- •Scanographic pulmonary compatible with COVID in the absence of any other etiology
- •Risk of deterioration, checking at least one of the following comorbidity criteria :
- •Chronic respiratory pathology
- •Cancer pathology
Exclusion Criteria
- •Patients admitted in intensive care within the first 6 hours of hospital care,
- •Patients after 10 days from the start of symptoms
- •Age \< 18 years and \> 90 years
- •Long-term oxygen-dependent patients (at home),
- •Decompensated chronic cardiac, respiratory, urological pathology
- •Patient refusing administration of blood products,
- •Allergic reaction to plasma products,
- •IgA deficiency,
- •Contraindication to transfusion
- •Ig transfusion within 30 days,
Arms & Interventions
SARS-CoV-2 patients treated with convalescent plasma
Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma.
Intervention: Transfusion of SARS-CoV-2 Convalescent Plasma.
SARS-CoV-2 patients treated with standard plasma
Subjects will receive an intravenous injection of standard Plasma.
Intervention: Transfusion of standard Plasma.
Outcomes
Primary Outcomes
Survival time without needs of a ventilator.
Time Frame: Day 30
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.
Secondary Outcomes
- Morbidity(Day 30)
- Decrease in the consumption of antibiotics(30 days)
- Mortality(Day 30)
- Transfusion endotheliopathy effect(At inclusion, Day 1, Day 7)
- Transfusion hemovigilance(30 days)
- Length of stay(Day 30)
- Effect on viral pharyngeal specimen clearance(At inclusion and Day 7)
- Effect on hemostasis disorders(At inclusion, Day 1 and every 48 hours)
- Effect on viral blood specimen clearance(At inclusion and Day 7)
- Kinetics of appearance of neutralizing antibodies(At inclusion, Day 7)
- Transfusion biological Inflammation effect(At inclusion, Day 1, Day 7)