COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04466540

Álvaro Avezum, Ph.D

aavezum@haoc.com.br

2020-07-10

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: it will be considered eligible those adults (equal to or greater than 18 years) seeking medical care with suspected or confirmed covid-19, with time between symptoms and inclusion ≤ 07 days, presenting mild symptoms, without indication of hospitalization and at least 1 risk factor for complication: > 65 years; hypertension; diabetes mellitus; asthma; copd or other chronic lung diseases; smoking; immunosuppression; obesity (defined as bmi equal to or greater than 30 kg/m2).

patients under 18 years old; hospitalization at the first medical care; positive test for influenza at the first medical care; known hypersensitivity to hydroxychloroquine / chloroquine; previous diagnosis of retinopathy or macular degeneration; previous diagnosis of long qt-syndrome, history of sudden death in close family members (parents and siblings), decompensated heart failure, unstable coronary artery disease, use of anti-arrhythmic drugs or other drugs that can increase the hydroxychloroquine bioavailability or enhance its effect; evidence of known liver disease, reported by the patient; evidence of known chronic kidney disease, reported by the patient; patients with pancreatitis; baseline ecg with qtc interval ≥ 480ms; chronic use of hydroxychloroquine/chloroquine for other reasons; pregnancy.

2

Hospital Alemão Oswaldo Cruz

18

100

Brazil

Mild disease at enrollment

1: Mild disease at enrollment

1372

Hospitalization

None

Phase 4

[{"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"}]