Title {1} |
Direct Antivirals Working against the Novel coronavirus – Azithromycin (DAWn-AZITHRO) A randomized, multicenter, open-label, adaptive, proof of concept clinical trial of new antivirals working against Sars-CoV2 – Azithromycin trial |
Trial registration {2a and 2b}. | EU Clinical trials register, EudraCT Nb 2020–001614-38. Start date 2020-04-22. |
Protocol version {3} | Version 6 |
Funding {4} |
RV is a Senior Clinical Research Fellow of the Research Foundation Flanders (FWO), which supports his institution (Univ. Hospitals/KU Leuven) by research funding. The project is also funded by a specific FWO fund (G0G4720N). RV has received specific funding for DAWn-AZITHRO by Univ. Hospitals Leuven (KOOR). WJ received specific funding for DAWn-AZITHRO by KU Leuven (Collen Charitable Foundation). Study is also funded by Life Sciences Research Partners (LSRP) and the COVID-19 fund of the KU Leuven. |
Author details {5a} |
IG: BREATHE, department CHROMETA, KU Leuven LL: Laboratory of Virology and Chemotherapy (Rega Institute) RV: BREATHE, department CHROMETA, KU Leuven WJ: BREATHE, department CHROMETA, KU Leuven AB: Leuven Biostatistics and Statistical Bioinformatics Centre GV: Leuven Biostatistics and Statistical Bioinformatics Centre PV: Centre for Molecular and Vascular Biology DAWn-Azithro consortium: Prof. Dr. W. Janssens Prof. Dr. R. Vos Dr. I. Gyselinck Prof. Dr. E. Vanderhelst Dr. B. Bouckaert Dr. P. Alexander Dr. N. De Maeyer Dr. E. Papleux Dr. A. Soenen Dr. A. Derweduwen Dr. K. Vandeurzen Dr. J. Martinot Dr. P. Goeminne Dr. H. Nguyen Prof. Dr. C. Pilette Dr. R. Schildermans Dr. L. Decoster |
Name and contact information for the trial sponsor {5b} |
Univ. Hospitals Leuven Herestraat 49, 3000 Leuven + 3216 33 22 11 |
Role of sponsor {5c} |
DAWn-AZITHRO is an academic, investigator–initiated and -led study by the (co-)authors. None of the study sponsor and funders was involved in any of the following: study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities |