COV-HCQ

Hydroxychloroquine for COVID-19

01/04/2020 to 30/09/2021

In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from Chinese COVID-19 patients suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of chloroquine.
We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess tolerability, safety and efficacy of hydroxychloroquine in the treatment of COVID-19.

220 consenting adult patients having confirmed COVID-19 will be recruited and randomly and blindly allocated in a 1:1 ratio to either hydroxychloroquine (600mg QD on day 1-7 with an additional dose on day 1 for patients ≥70kg bodyweight) or placebo. Sample size is calculated to detect with 80% power and 5% alpha a reduction in time to lower level of quantification (LLoQ) from 3 to 2 weeks.

Clinical and lab assessments will be done as requested by the attending physician or as required to analyse secondary and tertiary outcomes. Adverse events will be assessed at each visit. All additional medical interventions are allowed as judged by the treating physicians.

Primary outcome measure: Time to drop of RNA load below level of quantification in per protocol analysis (as defined by test manufacturer)

Secondary outcome measures: All-cause mortality within 30 days, proportion admitted to ICU, proportion requiring non-invasive ventilation, proportion requiring invasive ventilation, reduction in SARS-CoV-2 RNA load in upper respiratory tract specimen as assessed by area under RNA load curve, reduction in SARS-CoV-2 RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels

Safety endpoint: overall tolerability and safety of study drug; cardiac safety assessment

Exploratory outcome measures: effect of infection on cardiac function, immune responses, effect on clinical (symptoms) and laboratory parameters etc.