Hydroxychloroquine in Outpatient Adults With COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-12

Study Completion Date

2020-05-26

Brief Summary

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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

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Detailed Description

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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

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Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydroxychloroquine

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

Group Type EXPERIMENTAL

Hydroxychloroquine SAR321068

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Interventions

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Hydroxychloroquine SAR321068

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Placebo

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Other Intervention Names

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Plaquenil

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No