Hydroxychloroquine in Outpatient Adults With COVID-19

Phase 1

Terminated

• Conditions: Coronavirus Infection
• Interventions: Drug: Placebo; Drug: Hydroxychloroquine SAR321068

• Registration Number: NCT04333654
• Lead Sponsor: Sanofi

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 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)

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Study Start: 2020-04-12
• Primary Completion: 2020-05-26
• Study Completion: 2020-05-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo
Hydroxychloroquine	Hydroxychloroquine SAR321068	Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)	Baseline to Day 3	Viral load assessed by PCR from a nasopharyngeal swab
Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)	Baseline to Day 3	Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with resolution of fever	Baseline to end of study (Day14)	Resolution of fever defined as the first day of 2 consecutive daily temperatures \< 37.7 C
Percentage of participants hospitalized	Baseline to end of study (Day14)
Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load	Baseline to Day 5	Viral load assessed by PCR from a nasopharyngeal swab
Number of participants by PCR result status (positive or negative)	Baseline to end of study (Day14)	Viral load assessed by PCR from a nasopharyngeal swab
Number of participants with COVID-19 symptoms by severity	Baseline to end of study (Day14)	COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe)
Number of participants with Adverse Events	Baseline to end of study (Day14)
Time to resolution of COVID-19 Symptoms	Baseline to end of study (Day14)	COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe). Resolution of a symptom is defined as when a symptom previously scored ≥ 1 on the scale is scored as 0
Time to resolution of fever	Baseline to end of study (Day14)	Resolution of fever defined as the first day of 2 consecutive daily temperatures \< 37.7 C

Trial Locations

Locations (7)

Investigational Site Number 8400001; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 0561002; 🇧🇪 Lodelinsart, Belgium

Investigational Site Number 2501001; 🇫🇷 Bordeaux Cedex, France

Investigational Site Number 0561001; 🇧🇪 Bruxelles, Belgium

Investigational Site Number 2501002; 🇫🇷 Paris, France

Investigational Site Number 5281002; 🇳🇱 Harderwijk, Netherlands

Investigational Site Number 5281001; 🇳🇱 Groningen, Netherlands