COV201003: Spende von Antikörpern gegen nCoV (DAWN-Plasma)

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

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

Hôpital 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)

Dokumente
Protocol  
Report

Q1 2022

Publication

 

Referenzen

Clinicaltrials.gov: NCT04429854

Webpage: https://dawnplasma.be/