COV201003: Donated antibodies working against nCoV (DAWN-Plasma)

Summary (French or Dutch)

At the end of 2019, a new coronavirus (the SARS-CoV-2) emerged that spread rapidly around the world and led to a pandemic. The disease caused by this virus, COVID-19, is mild in many people but can sometimes have a serious course. There are currently no known effective treatments for patients with COVID-19. This study investigates whether plasma from cured COVID-19 patients can be used to make the course of COVID-19 less severe.

The plasma of cured COVID-19 patients contains antibodies. These are proteins that are produced by humans to fight infections such as COVID-19. By collecting plasma from cured patients and giving it to patients who are ill, these antibodies are passed on and the disease may be slowed down or stopped.

Giving plasma has already been tested on a smaller scale in other viral diseases such as flu or Ebola. However, large studies have not been conducted to demonstrate this effect clearly and unequivocally, either because a vaccine or a new drug was quickly developed for these diseases or because the epidemic could be quickly contained. Nevertheless, there is a lot of experience in giving plasma to treat clotting disorders or diseases of the immune system.

Since every viral infection is different, it is necessary to check whether this form of treatment is safe and effective for each new infection for which it is tested. It is possible, for example, that antibodies previously developed against another coronavirus may cause the disease to worsen. Therefore, caution should always be exercised.

Donor-plasma treatment has already been used in a number of Chinese patients and it seems to have a possible positive effect, but these results have to be confirmed. In this study two groups are compared with each other. One group receives plasma from a cured patient on top of the standard care and a second group receives only the standard care. Hard conclusions can then be drawn from the study as to whether or not giving convalescent plasma is useful.

Trial Description
Title

Donated antibodies working against nCoV (DAWN-Plasma)

Participants (P)

Eligible adult patients who tested positive for SARS-CoV-2 and are admitted to the hospital and have at least one of the following:

a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or

b. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or

c. Requiring supplemental oxygen.

Intervention (I)

Treatment with 4 units of convalescent plasma:

2 units of plasma are administered within 12h after randomization, but preferably as soon as practically possible

2 units of plasma should be administered between 24h and 36h after the first infusion

Other investigational products may be added as part of the adaptive study design.

Control (C)

Standard of Care (SOC)

Outcome (O)

Primary outcome: Patients requiring mechanical ventilation or death

Key secondary outcome: Clinical status of subject at day 15 and day 30 (on a 10-point “WHO progression” ordinal scale)

Trial Design

Phase II proof-of-concept study

Randomized, Open-label, Multicentre, Adaptive Study design

Sample Size

483 patients randomised 2:1

322 patients receiving plasma

161 patients receiving SOC

Trial duration

 20 months

Budget

€ 2 million

Status

Open to recruitment

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof. Dr. Geert Meyfroidt

 

Participating sites

UZ Leuven

UZ Brussel

Hôpital Erasme Bruxelles

UCL St Luc Bruxelles

St Pierre University Hospital Brussels

CHU Liège

AZ Delta Roeselare

CHU Brugmann

CHC Liège Mont Légia    

Jules Bordet Institute Brussels

ZNA Antwerpen Stuivenberg

AZ Groeninge Kortrijk

Hopital Jolimont

CHR Citadelle Luik

External Partners

Rode Kruis Vlaanderen

Croix Rouge

REGA institute Leuven (Piet Maes)

Sciensano (Cyril Barbezange)

University of Liège (Daniel Desmecht)

ITM (Kevin Arïen)

Documents
Protocol  
Report

Q1 2022

Publication

 

References

Clinicaltrials.gov:  pending

Webpage: