Zusammenfassung (Niederländisch oder Französisch oder Englisch)
TRIAL DESCRIPTION
| Title | Multicentrische en gerandomiseerde studie: evaluatie van de werkzaamheid en veiligheid van behandelingen voor gehospitaliseerde patiënten met COVID-19 |
| Participants (P) | Hospitalised adult (≥18 years old) patients with COVID-19 |
| Intervention (I) | (2) SoC + remdesivir, (3) SoC + lopinavir/ritonavir, (stopped 04/07/2020) (4) SoC + lopinavir/ritonavir + IFN ß-1a and (stopped 04/07/2020) (5) SoC + hydroxychloroquine. (suspended 24/05/2020, then stopped 17/06/2020) Other arms can be added as evidence emerges from other candidate therapeutics |
| Control (C) | (1) Standard of Care (SOC) |
| Outcome (O) | The primary endpoint is subject clinical status (on a 7-point ordinal scale) on Day 15 |
| Trial Design | This study is an adaptive, randomised, open clinical trial to evaluate the safety and efficacy of possible therapeutic agents in hospitalised adult patients diagnosed with COVID-19 |
| Sample Size | 3,200 planned in Europe 150 planned in Belgium |
| Trial duration | 13 months |
| Budget | €630,000 |
TRIAL TEAM
|
Sponsor |
Inserm - Pôle Recherche Clinique (PRC) Biopark, Bâtiment A, 8 rue de la Croix Jarry, 75013 Paris |
|
Chief Investigator |
Dr Florence Ader |
|
Coordinating Investigator BE |
Dr Maya Hites, PhD - Hospital Erasme |
|
Participating investigators |
Hospital Erasme (BCC), CHR Liège Citadelle, UCL Saint-Luc |
DOKUMENTE
| Protocol | View protocol BMJ Open |
| Results | View publication NEJM |
For timelines and recruitment, see dashboard
REFERENZEN
