Hydroxychloroquine in Outpatient Adults With COVID-19

Inclusion criteria : * Participants with diagnosis of COVID-19 via an approved or authorized molecular test * Presence of symptoms compatible with COVID-19 at the time of screening * Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less * Female participants must use an acceptable birth control method, as specified by each site and country Exclusion criteria: * COVID-19 disease requiring the use of supplemental oxygen * Electrocardiogram (ECG) tracing with QTc interval \> 450 ms for men, \> 470 ms for women (Fridericia algorithm recommended) * Bradycardia (\< 50 beats/min) * History of cardiac disease (eg. congestive heart failure, myocardial infarction) * History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Women who are pregnant or breastfeeding * Concurrent antimicrobial therapy * Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds * Hydroxychloroquine use within 2 months before enrollment * History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis * History of retinopathy * History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death * History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.