NCT04333654

Hydroxychloroquine in Outpatient Adults With COVID-19

A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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)

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine SAR321068	Pharmaceutical form:Tablet Route of administration: Oral
DRUG	Placebo	Pharmaceutical form:Tablet Route of administration: Oral

Timeline

• Start date: 2020-04-12
• Primary completion: 2020-05-26
• Completion: 2020-05-26
• First posted: 2020-04-03
• Last updated: 2025-09-23

Locations

7 sites across 4 countries: United States, Belgium, France, Netherlands

Regulatory

• FDA-regulated drug study