Hydroxychloroquine in Outpatient Adults With COVID-19

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Coronavirus Infection

In brief

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

Key facts

Study ID

NCT04333654

Run by

Sanofi

People needed

8

Starts

2020-04-12

Expected to finish

2020-05-26

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8400001 — Boston, Massachusetts, United States
• Investigational Site Number 0561001 — Brussels, Belgium
• Investigational Site Number 0561002 — Lodelinsart, Belgium
• Investigational Site Number 2501001 — Bordeaux, France
• Investigational Site Number 2501002 — Paris, France
• Investigational Site Number 5281001 — Groningen, Netherlands
• Investigational Site Number 5281002 — Harderwijk, Netherlands

Full record on ClinicalTrials.gov

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