Hydroxychloroquine in Outpatient Adults With COVID-19

A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

Primary Objective:

To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives:

• To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
• To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

The duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)

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.