Coronavirus Infection
Conditions
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)
Interventions
DRUGHydroxychloroquine SAR321068
Pharmaceutical form:Tablet Route of administration: Oral
DRUGPlacebo
Pharmaceutical form:Tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available) | Baseline to Day 3 | 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) | Baseline to Day 3 | Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with COVID-19 symptoms by severity | Baseline to end of study (Day14) | 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 | Baseline to end of study (Day14) | 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 | Baseline to end of study (Day14) | Resolution of fever defined as the first day of 2 consecutive daily temperatures \< 37.7 C |
| Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load | Baseline to Day 5 | Viral load assessed by PCR from a nasopharyngeal swab |
| Percentage of participants hospitalized | Baseline to end of study (Day14) | — |
| Number of participants with Adverse Events | Baseline to end of study (Day14) | — |
| Percentage of participants with resolution of fever | Baseline to end of study (Day14) | Resolution of fever defined as the first day of 2 consecutive daily temperatures \< 37.7 C |
| Number of participants by PCR result status (positive or negative) | Baseline to end of study (Day14) | Viral load assessed by PCR from a nasopharyngeal swab |
Countries
Belgium, France, Netherlands, United States
Outcome results
None listed