COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04333654

Clinical Sciences & Operations Sanofi

Contact-US@sanofi.com

2020-04-03

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

- 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.

2

Sanofi

18

None

Belgium;France;Netherlands;United States

No restriction on type of patients

0: No restriction on type of patients

8

Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available);Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)

None

Phase 1

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]