Zusammenfassung (Niederländisch oder Französisch oder Englisch)
| 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 |
|
Sponsor |
UZ Leuven |
|
Chief Investigator |
Prof. Dr. Geert Meyfroidt
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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) |
| Protocol | Download protocol View publication Trials |
| Results | Download report |
For timelines and recruitment, see dashboard
