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

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

Detailed Description

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)

Coronavirus Infection

Drug: Hydroxychloroquine SAR321068
Pharmaceutical form:Tablet Route of administration: Oral
Other Name: Plaquenil

Drug: Placebo
Pharmaceutical form:Tablet Route of administration: Oral

Eligibility Criteria

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.

Eligibility Gender
Eligibility Age
Minimum: 18 Years~Maximum: 80 Years
United States

Investigational Site Number 8400001
Boston, Massachusetts, 02115

Clinical Sciences & Operations
Study Director

NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome