Status:
TERMINATED
Hydroxychloroquine in Outpatient Adults With COVID-19
Lead Sponsor:
Sanofi
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 ...
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)
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04333654
Start Date
April 12 2020
End Date
May 26 2020
Last Update
September 23 2025
Active Locations (7)
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1
Investigational Site Number 8400001
Boston, Massachusetts, United States, 02115
2
Investigational Site Number 0561001
Brussels, Belgium, BE-1200
3
Investigational Site Number 0561002
Lodelinsart, Belgium, 6042
4
Investigational Site Number 2501001
Bordeaux, France, 33076