NL-OMON49040
Completed
Not Applicable
A phase 1b, randomized, double-blinded, placebo-controlled study of hydroxychloroquine in outpatient adults with COVID-19 - EFC16855
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Corona
- Sponsor
- Sanofi-aventis
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Participants \* 18 years and \* 80 years of age
- •\- Participants with a 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 suplemental 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 (e.g. congestive heart failure, myocardial
- •infarction)
- •\- History of Glucose\-6\-phosphate dehydrogenase (G6PD) deficiency
- •\- Women who are pregnant or breastfeeding
- •\- Concurrent antimicrobial therapy
- •\- Hydroxychloroquine use within 2 months before enrollment
Outcomes
Primary Outcomes
Not specified
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