DAWN-antivirals: Die DAWN-Studie zur antiviralen Behandlung von ambulanten COVID-19-Patienten (COV201279)

Participants (P)

•    Aged 40 years or older;
•    At least 2 Covid-19 suggestive symptoms with onset of a maximum of 5 days prior to enrolment, and which cannot be explained by an alternative cause, and defined by the current Sciensano case definition;
•    Positive result on a PCR test or rapid Antigen in the 7 days before inclusion or at the time of inclusion in the study;
Patient is community dwelling;

Intervention (I)

Camostat, 200 mg four times a day, for 7 days, oral tablets (total daily dose of 800 mg)

Molnupiravir, 800 mg (4 capsules of 200 mg) two times a day, for 5 days, oral capsule (total daily dose of 1600 mg)

Control (C)

Placebo, four times a day, for 7 days, oral tablets

Outcome (O)

Trial Design

Sample Size

Trial duration

Budget

€2,590,000

Sponsor

UZ Leuven – KU Leuven

Chief Investigator

Prof Ann Van den Bruel, MD

External Partners

KU Leuven - Academic Centre of General Practice
UZ Leuven - Lung diseases and internal medicine
U Liège - Dept. medicine, research group general practice and health
UGent - Primary Care and internal medicine
UA - Primary Care
VUB - Family Medicine and Chronic Care
ZOL CTC (data management)

Number of participating sites

Approximately 125 GPs working in 5-10 triage points - 50 GP practices

Academic centre collaborating investigators

KU Leuven - Nicolas Delvaux, Jan Verbakel, Birgitte Schoenmakers 
U Liège – Laetitia Buret
UGent - An De Sutter, Stefan Heytens
UA - Samuel Coenen
VUB - Dirk Devroey