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Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients.

NCT04372979 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Transfusion of SARS-CoV-2 Convalescent Plasma.

2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.

DRUG

Transfusion of standard Plasma.

2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Principal Investigators

  • Nathalie KOULMANN · Direction Centrale du Service de Santé des Armées (DCSSA)

  • Catherine VERRET · Service de Santé des Armées-Direction de la Formation de la Recherche et de l'Innovation

  • Christophe MARTINAUD · Centre de Transfusion Sanguine des Armées

  • Jean-Luc BOSSON · Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372979 on ClinicalTrials.gov