Clinical trial NCT04333654: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Coronavirus Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-04-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)
timeFrame: Baseline to Day 3
measure: Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)
timeFrame: Baseline to Day 3
Secondary outcomes:
measure: Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load
timeFrame: Baseline to Day 5
measure: Number of participants by PCR result status (positive or negative)
timeFrame: Baseline to end of study (Day14)
measure: Number of participants with COVID-19 symptoms by severity
timeFrame: Baseline to end of study (Day14)
measure: Time to resolution of COVID-19 Symptoms
timeFrame: Baseline to end of study (Day14)
measure: Time to resolution of fever
timeFrame: Baseline to end of study (Day14)
measure: Percentage of participants with resolution of fever
timeFrame: Baseline to end of study (Day14)
measure: Percentage of participants hospitalized
timeFrame: Baseline to end of study (Day14)
measure: Number of participants with Adverse Events
timeFrame: Baseline to end of study (Day14)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Investigational Site Number 8400001
state: Massachusetts
city: Bruxelles
country: Belgium
facility: Investigational Site Number 0561001
city: Lodelinsart
country: Belgium
facility: Investigational Site Number 0561002
city: Bordeaux Cedex
country: France
facility: Investigational Site Number 2501001
city: Paris
country: France
facility: Investigational Site Number 2501002
city: Groningen
country: Netherlands
facility: Investigational Site Number 5281001
city: Harderwijk
country: Netherlands
facility: Investigational Site Number 5281002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: