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Hydroxychloroquine in Outpatient Adults With COVID-19

TerminatedPhase 1

Sponsor: Sanofi

Conditions: Coronavirus Infection

Interventions: Hydroxychloroquine SAR321068, Placebo

Countries: United States, Belgium, France, Netherlands

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (7)

Boston, Massachusetts, United States
Brussels, Belgium
Lodelinsart, Belgium
Bordeaux, France
Paris, France
Groningen, Netherlands
Harderwijk, Netherlands