click on circles to display study description...

Reis (Hydroxychloroquine) (TOGETHER), 2021 NCT04403100

hydroxychloroquine (n=214) vs. placebo (n=227)

randomized controlled trial

Hydroxychloroquine
Hydroxychloroquine loading dose of 800 mg at the time of randomization and then 400 mg in daily doses at 8:00 AM for 9 days.

Placebo
Corresponding tablets of inert material (talc). Placebo bottles were matched for the same number of tablets as active lopinavir-ritonavir.

3 arms: Hydroxychloroquine, lopinavir-ritonavir or placebo (1:1:1).

COVID 19 outpatients

Patients 18 years or older; reported less than 8 days since onset of flulike symptoms or chest computerized tomography scan consistent with COVID-19 and at least one additional criterion for high risk: aged 50 years or older; presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, or emphysema; diabetes requiring oralmedication or insulin; hypertension requiring treatment; known cardiovascular diseases (congestive heart failure of any etiology, documented coronary artery disease, clinically manifest miscellaneous heart disease); symptomatic lung disease on chronic treatment; history of transplantation; obesity (body mass index 30 [calculated as weight in kilograms divided by height in meters squared]); immunocompromised status due to disease (eg, those living with HIV with a CD4 T-cell count of <200 cells/mm3, confirmed malignant neoplasm); immunocompromised status due to medication (eg, people taking 10 mg or more of prednisone equivalents a day); and patients with cancer.

Double-blind.

10 cities in Brazil.

The trial was stopped after the interim analysis for futility with a sample size of 685 patients.

COPE – Coalition V, 2022 NCT04466540

hydroxychloroquine (n=689) vs. placebo (n=683)

randomized controlled trial

hydroxychloroquine 400 mg BID in the first day, 400 mg OD thereafter for a total of seven days

placebo

COVID 19 outpatients

double-blind

56 Brazilian sites

COVID-PEP Severity (Skipper), 2020 NCT04308668

hydroxychloroquine (n=244) vs. placebo (n=247)

randomized controlled trial

hydroxychloroquine 600mg
oral hydroxychloroquine, 800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days

placebo

COVID 19 outpatients

double-blind

United States and Canada (40 states and 3 provinces)

PATCH Cohort 1 (Amaravadi), 2021 NCT04329923

hydroxychloroquine (n=15) vs. standard of care (n=13)

randomized controlled trial

hydroxychloroquine
2x200mg twice a day

placebo

COVID 19 outpatients

double-blind

1 centre, USA

interim analysis. study discontinuated due to rapide decline of infection rate during the study accrual period.

BCN PEP-CoV-2-Study 2 (Mitja et al. Clin Infect Dis), 2020 NCT04304053

hydroxychloroquine (n=137) vs. standard of care (n=157)

randomized controlled trial

hydroxychloroquine 400mg
hydroxychloroquine (800 mg on day 1, followed by 400 mg once daily for 6 days)

standard of care

COVID 19 outpatients

moste patients were healthcare workesr (86.7%)

open-label

Catalonia, Spain