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.