The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a
case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in
Germany. There is no data available on the efficacy of antiviral agents for the treatment of
COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and
anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or
hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect
was seen when hydroxychloroquine was used together with azithromycin in a small series of
COVID-19 patients. However, so far all published evidence is based on non-controlled use of
hydroxychloroquine.
We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate
disease in Germany to assess virological efficacy, tolerability and safety of
hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify
an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice
for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment
and post-exposure prophylaxis of COVID-19.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital Tuebingen
Collaborators:
Bernhard Nocht Institute for Tropical Medicine Robert Bosch Medical Center Universitätsklinikum Hamburg-Eppendorf