COMIHY

Hydroxychloroquine for the treatment of mild COVID-19 disease

10/04/2020 to 09/04/2022

In vitro data show that hydroxychloroquine can inhibit the replication of SARS-CoV-2, and individual reports from Chinese and European COVID-19 patients suggest that hydroxychloroquine is a good candidate for treatment. Previously published clinical data are based on the uncontrolled use of hydroxychloroquine.
Therefore, we plan to conduct a double-blind, randomized, placebo-controlled, multicenter phase II study in Germany. The aim of this study is to investigate the effect of hydroxychloroquine on the duration of symptoms in patients with mild COVID-19 on the one hand and on virus elimination on the other hand.

2,700 adult study participants with mild COVID-19 will be recruited and will receive randomly and blindly either hydroxychloroquine (600 mg/day for 7 days) or placebo. The sample size is calculated to detect a difference in disease duration of at least 1 day with 80% power and a one-sided confidence interval of 2.5%. Clinical testing is to be started at the centres in Tübingen and Hamburg and will be extended to other centres in the near future by the German Society for Infectiology (DGI).

Primary endpoint:
Time to disappear of clinical signs and symptoms of patients with mild COVID-19, assessed by daily self-evaluation

Secondary endpoints:
- difference between hydroxychloroquine and placebo treated patients on an ordinal scale (death, intensive care, hospitalization, ongoing disease, recovery)
- total lethality within 28 days

Virological endpoints:
- proportion of patients with negative COVID-19 PCR test on day 14
- change in COVID-19 viral load from day 1 to day 14

Safety assessment:
Evaluation of tolerability and safety at each study visit