Hydroxychloroquine in Outpatient Adults With COVID-19

NCT04333654 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: EFC168552020-001269-35U1111-1249-6168
• Study Type: interventional
• Target: 8
• Locations: 4 countries
• Sites: 7

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

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (2)

• Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)

  Viral load assessed by PCR from a nasopharyngeal swab

  Baseline to Day 3

• Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)

  Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab

  Baseline to Day 3

Secondary Outcomes (8)

• Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load

  Baseline to Day 5

• Number of participants by PCR result status (positive or negative)

  Baseline to end of study (Day14)

• Number of participants with COVID-19 symptoms by severity

  Baseline to end of study (Day14)

• Time to resolution of COVID-19 Symptoms

  Baseline to end of study (Day14)

• Time to resolution of fever

  Baseline to end of study (Day14)

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days

Drug: Hydroxychloroquine SAR321068

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Hydroxychloroquine SAR321068 DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Also known as: Plaquenil

Hydroxychloroquine

Placebo DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Investigational Site Number 8400001

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 0561001

Brussels, BE-1200, Belgium

Location

Investigational Site Number 0561002

Lodelinsart, 6042, Belgium

Location

Investigational Site Number 2501001

Bordeaux, 33076, France

Location

Investigational Site Number 2501002

Paris, 75005, France

Location

Investigational Site Number 5281001

Groningen, 9728 NZ, Netherlands

Location

Investigational Site Number 5281002

Harderwijk, 3844 DG, Netherlands

Location

Related Links

• EFC16855 Plain Language Results Summary

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: April 12, 2020
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); FR (2); US (1); BE (2)