Hydroxychloroquine for COVID-19

Hydroxychloroquine can inhibit SARS-CoV-2 viral replication and Chinese and French studies on COVID-19 patients suggest hydroxychloroquine is a candidate for treatment. We conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease to assess virological efficacy, tolerability and safety of hydroxychloroquine. 220 consenting adult patients having confirmed COVID-19 will be recruited and randomly and blindly allocated in 1:1 ratio to 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 physician or as required to analyse secondary and tertiary outcomes. Adverse events will be assessed at each visit. All other medical interventions are allowed as judged by the 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 viral RNA load in upper respiratory tract specimen as assessed by area under RNA load curve, reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA by 2 log-levels Safety endpoint: overall tolerability and safety of study drug; cardiac safety assessment.