COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04328961

Ruanne V. Barnabas, MBChB, Dphil

Meighan Krows, meigs@uw.edu (PI email not reported)

2020-04-01

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: men or women 18 to 80 years of age inclusive, at the time of signing the informed consent willing and able to provide informed consent had a close contact of a person (index) with known pcr-confirmed sars-cov-2 infection or who is currently being assessed for covid-19. close contact defined as: household contact (i.e., residing with the index case in the 14 days prior to index diagnosis) medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves) less than 4 days since last exposure (close contact with a person with sars-cov-2 infection) to the index case body weight < 100 kg (self-reported) access to device and internet for telehealth visits

- known hypersensitivity to hcq or other 4-aminoquinoline compounds - currently hospitalized - symptomatic with subjective fever, cough, or sore throat - current medications exclude concomitant use of hcq - concomitant use of other anti-malarial treatment or chemoprophylaxis - history of retinopathy of any etiology - psoriasis - porphyria - known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 k) - concomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen - known liver disease - known long qt syndrome - use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period

2

University of Washington

18

80

United States

Close contacts to covid patients

N/A

943

Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection;The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection

None

Phase 2/Phase 3

[{"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"}]