COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04379492

Genovefa Papanicolaou

papanicg@mskcc.org

2020-05-07

Withdrawn

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - age 18 years and older - subjects must have a documented positive test for the sars-cov-2 infection within 7 days of randomization - subject must be hospitalized within 72 hours of randomization - subjects must be receiving standard of care for sars-cov-2 - subject/legally authorized representative (lar) must have the ability to understand and give informed consent - subject must be able to take and absorb hydroxychloroquine at the discretion of the investigator

- prior receipt of hydroxychloroquine for treatment or prophylaxis of sars-cov-2 or patient is taking hydroxychloroquine for other approved indications (e.g., lupus, rheumatoid arthritis) - no documented sars-cov-2 infection - mechanical ventilation - known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives preexisting retinopathy documented in medical history - pregnancy or breastfeeding - concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins (rifampin, rifabutin) - antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide) - history of glucose-6-phosphate dehydrogenase deficiency - pre-treatment corrected qt interval (qtc) >500 milliseconds - pressor requirement to maintain blood pressure - alanine aminotransferase (alt) and/or asparate aminotransferase (ast) level > 5x upper limit of normal - creatinine clearance <30 ml/min or requirement of dialysis or continuous venovenous hemofiltration - concomitant participation in a therapeutic trial for sars-cov-2 or receiving any experimental treatment for sars-cov-2 within 7 days of randomization - any condition that in the opinion of the principal investigator would prevent participation in the trial or would interfere with the trial endpoints

2

Memorial Sloan Kettering Cancer Center

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI);Number of participants requiring mechanical ventilation for respiratory failure

None

Phase 2

[{"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"}]