Hydroxychloroquine for the Treatment of Mild COVID-19 Disease
Status:
Terminated
Trial end date:
2020-10-12
Target enrollment:
Participant gender:
Summary
The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case
fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) 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 [1] replication
and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a
good candidate for treatment. No data have been published and reported evidence is based on
non-controlled use of hydroxychloroquine.
The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on
duration of symptoms in mild COVID-19 patients and time of virus shedding as an important
tool to reduce the risk of further community transmissions. This data will inform practice
for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment
and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community
transmission.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital Tuebingen
Collaborators:
Bernhard Nocht Institute for Tropical Medicine Robert Bosch Medical Center Universitätsklinikum Hamburg-Eppendorf