Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients. (PLASCOSSA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04372979|
Recruitment Status : Not yet recruiting
First Posted : May 4, 2020
Last Update Posted : May 15, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Transfusion of SARS-CoV-2 Convalescent Plasma. Drug: Transfusion of standard Plasma.||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: SARS-CoV-2 patients treated with convalescent plasma
Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma.
Drug: Transfusion of SARS-CoV-2 Convalescent Plasma.
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
Active Comparator: SARS-CoV-2 patients treated with standard plasma
Subjects will receive an intravenous injection of standard Plasma.
Drug: Transfusion of standard Plasma.
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.
- 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.
- Morbidity [ Time Frame: Day 15 ]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.
- Morbidity [ Time Frame: Day 30 ]Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.
- Mortality [ Time Frame: Day 30 ]
- Length of stay [ Time Frame: Day 30 ]
- Effect on viral pharyngeal specimen clearance [ Time Frame: At inclusion and Day 7 ]Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.
- Effect on viral blood specimen clearance [ Time Frame: At inclusion and Day 7 ]Quantitative SARS-CoV2 PCR carried out on blood specimen.
- Effect on hemostasis disorders [ Time Frame: At inclusion, Day 1 and every 48 hours ]Effects on biological hemostasis parameters disorders.
- Kinetics of appearance of neutralizing antibodies [ Time Frame: At inclusion, Day 7 ]Anti-SARS-Cov2 immunoglobulin G/A level and anti-SARS-Cov2 neutralizing antibody levels.
- Transfusion endotheliopathy effect [ Time Frame: At inclusion, Day 1, Day 7 ]Evolution of biological endotheliopathy parameters
- Transfusion biological Inflammation effect [ Time Frame: At inclusion, Day 1, Day 7 ]Evaluation of biological dosages on inflammation effects
- Transfusion hemovigilance [ Time Frame: 30 days ]Number of transfusion adverse events
- Decrease in the consumption of antibiotics [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372979
|Contact: Christophe MARTINAUD, PU PH||+33 email@example.com|
|Contact: Christophe RENARD||+33 firstname.lastname@example.org|
|Clamart, France, 92140|
|Contact: Marc ALETTI email@example.com|
|Sub-Investigator: Jean-Paul HYRIEN|
|Sub-Investigator: Damien RICARD|
|Sub-Investigator: Katia AYMART|
|Marseille, France, 13013|
|Contact: Hélène SAVINI firstname.lastname@example.org|
|Saint-Mandé, France, 94160|
|Contact: Cécile FICKO email@example.com|
|HIA Sainte Anne|
|Toulon, France, 83000|
|Contact: Fabien DUTASTA firstname.lastname@example.org|
|Study Director:||Hervé FOEHRENBACH||Direction Centrale du Service de Santé des Armées (DCSSA)|
|Study Director:||Catherine VERRET||Service de Santé des Armées-Direction de la Formation de la Recherche et de l'Innovation|
|Principal Investigator:||Christophe MARTINAUD||Centre de Transfusion Sanguine des Armées|
|Principal Investigator:||Jean-Luc BOSSON||Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas|