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

April 6, 2022 updated by: Direction Centrale du Service de Santé des Armées

Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92140
        • HIA Percy
      • Marseille, France, 13013
        • Hia Laveran
      • Saint-Mandé, France, 94160
        • Hia Begin
      • Toulon, France, 83000
        • HIA Sainte Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-90 years ;
  2. COVID-19 confirmed case ;

  3. Cases showing respiratory symptoms, checking at least one of the following criteria:

    1. Cough, dyspnea, respiratory rate > 24 breaths/min
    2. Oxygen saturation < 95% at rest in ambient air
    3. PaO2 < 70mmHg
    4. Scanographic pulmonary compatible with COVID in the absence of any other etiology

  4. Risk of deterioration, checking at least one of the following comorbidity criteria :

    1. Chronic respiratory pathology
    2. Diabetes
    3. Cancer pathology
    4. Cardiovascular disease
    5. Chronic kidney failure
    6. Congenital or acquired immunodeficiency
    7. Cirrhosis at stage B
    8. Major sickle cell syndrome
    9. BMI > 30 kg/m2

OR one of the biological criteria :

  1. D-dimer 1 µg/mL,
  2. Lymphocytes < 0.8 G/L,
  3. Ferritin > 300 µg/L,
  4. Troponin I > 11 pg/mL or Troponin T > 24.8 pg/mL

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,
  • Patient currently participating to another clinical trial,
  • Pregnant women,
  • No affiliated to the social security,
  • Person deprived of liberty by a legal or administrative decision, person under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 15
Morbidity
Time Frame: Day 30
Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.
Day 30
Mortality
Time Frame: Day 30
Day 30
Length of stay
Time Frame: Day 30
Day 30
Effect on viral pharyngeal specimen clearance
Time Frame: At inclusion and Day 7
Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.
At inclusion and Day 7
Effect on viral blood specimen clearance
Time Frame: At inclusion and Day 7
Quantitative SARS-CoV2 PCR carried out on blood specimen.
At inclusion and Day 7
Effect on hemostasis disorders
Time Frame: At inclusion, Day 1 and every 48 hours
Effects on biological hemostasis parameters disorders.
At inclusion, Day 1 and every 48 hours
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.
At inclusion, Day 7
Transfusion endotheliopathy effect
Time Frame: At inclusion, Day 1, Day 7
Evolution of biological endotheliopathy parameters
At inclusion, Day 1, Day 7
Transfusion biological Inflammation effect
Time Frame: At inclusion, Day 1, Day 7
Evaluation of biological dosages on inflammation effects
At inclusion, Day 1, Day 7
Transfusion hemovigilance
Time Frame: 30 days
Number of transfusion adverse events
30 days
Decrease in the consumption of antibiotics
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Collaborators

University Hospital, Grenoble

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01166-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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