Hydroxychloroquine in Outpatient Adults With COVID-19
Purpose
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
Condition
- Coronavirus Infection
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Hydroxychloroquine |
Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days |
|
Placebo Comparator Placebo |
Matching placebo |
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Recruiting Locations
More Details
- NCT ID
- NCT04333654
- Status
- Terminated
- Sponsor
- Sanofi
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)