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Hydroxychloroquine in Outpatient Adults With COVID-19

Primary Purpose

Coronavirus Infection

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Hydroxychloroquine SAR321068

Placebo

About this trial

This is an interventional treatment trial for Coronavirus Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 8400001
Investigational Site Number 0561001
Investigational Site Number 0561002
Investigational Site Number 2501001
Investigational Site Number 2501002
Investigational Site Number 5281001
Investigational Site Number 5281002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxychloroquine

Placebo

Arm Description

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

Matching placebo

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Viral load assessed by PCR from a nasopharyngeal swab

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

Viral load assessed by PCR from a nasopharyngeal swab

Number of participants with COVID-19 symptoms by severity

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)

Time to resolution of COVID-19 Symptoms

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

Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

Percentage of participants with resolution of fever

Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

Percentage of participants hospitalized

Number of participants with Adverse Events

Full Information

NCT ID

NCT04333654

First Posted

April 1, 2020

Last Updated

April 21, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04333654

Brief Title

Hydroxychloroquine in Outpatient Adults With COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

Rate of enrollment too slow to allow completion in a reasonable timeframe

Study Start Date

April 12, 2020 (Actual)

Primary Completion Date

May 26, 2020 (Actual)

Study Completion Date

May 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroxychloroquine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine SAR321068

Other Intervention Name(s)

Plaquenil

Intervention Description

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form:Tablet Route of administration: Oral

Primary Outcome Measure Information:

Title

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

Description

Viral load assessed by PCR from a nasopharyngeal swab

Time Frame

Baseline to Day 3

Title

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

Description

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

Time Frame

Baseline to Day 3

Secondary Outcome Measure Information:

Title

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

Description

Viral load assessed by PCR from a nasopharyngeal swab

Time Frame

Baseline to Day 5

Title

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

Description

Viral load assessed by PCR from a nasopharyngeal swab

Time Frame