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

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

ArmDescriptionAssigned Intervention
Experimental
Hydroxychloroquine
Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days
  • Drug: Hydroxychloroquine SAR321068
    Pharmaceutical form:Tablet Route of administration: Oral
    Other names:
    • Plaquenil
Placebo Comparator
Placebo
Matching placebo
  • Drug: Placebo
    Pharmaceutical form:Tablet Route of administration: Oral

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)

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.