Hydroxychloroquine in Outpatient Adults With COVID-19

Sanofi

Status and phase: Terminated; Phase 1

Conditions: Coronavirus Infection

Treatments: Drug: Hydroxychloroquine SAR321068; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04333654

U1111-1249-6168 (Other Identifier)

EFC16855

2020-001269-35 (EudraCT Number)

Details and patient eligibility

About

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

Full 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)

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine SAR321068

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo