Hydroxychloroquine in Outpatient Adults With COVID-19

• Status: Terminated
• Trial end date: 2020-05-26
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Hydroxychloroquine

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.