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HERO-HCQ (Naggie), 2021 NCT04334148

hydroxychloroquine (n=683) vs. placebo (n=676)

randomized controlled trial

hydroxychloroquine
loading dose of HCQ 600 mg twice on Day 1 followed by 400 mg daily for 29 days

placebo

COVID-19 prophylaxis (excluding children)

double blind, randomized

34 clinical centers in the United States

Enrollment for the study was closed before full accrual due to difficulties recruiting additional participants

EPICOS (Polo), 2022

hydroxychloroquine (n=231) vs. placebo (n=223)

randomized controlled trial

Daily hydroxychloroquine for 12 weeks

placebo

COVID-19 prophylaxis (excluding children)

double blind

Spain, Bolivia, and Venezuela

2x2 factorial design but analyzed as 4 groups

COVID-PEP-Post exposure (Boulware), 2020 NCT04308668

hydroxychloroquine (n=414) vs. placebo (n=407)

randomized controlled trial

hydroxychloroquine
hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days)

placebo
folate

COVID-19 prophylaxis (excluding children)

adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure)

double-blind

United States, Canada

prematurely stopped at the third interim analysis for futility

COVID PREP HCQ (2x week, Rajasingham), 2020 NCT04328467

hydroxychloroquine (n=495) vs. placebo (n=494)

randomized controlled trial

hydroxychloroquine
hydroxychloroquine:loading dose of 400mg (two 200mg tablets) twice separated by 6-8 hours thereafter 400mg twice weekly for 12 weeks

placebo
placebo

3 arms : hydroxychloroquine 400mg weekly ; hyrdoxychloroquine 400mg twice weekly ; placebo

COVID-19 prophylaxis (excluding children)

persons working in emergency departments, persons working in intensive care units, persons performing aerosol generating procedures, first responders

double-blind, randomized

USA Canada

Rojas-Serrano, 2021 NCT04318015

hydroxychloroquine (n=65) vs. placebo (n=65)

randomized controlled trial

Hydroxychloroquine
Hydroxychloroquine 200mg per day for 60 days.

Placebo

COVID-19 prophylaxis (excluding children)

Healthcare workers (nurses, nursing aides, cleaning staff, orderlies, respiratory therapists and physicians) 18 years old or older, with high-risk exposure to SARS-Cov-2 as they were taking care of hospitalized patients with COVID19. At baseline, included subjects had to be asymptomatic with a negative PCR-RT SARS-CoV2 test. Subjects with previous SARS-CoV2 infection or actual consumers of hydroxychloroquine or chloroquine (a 30 day wash out period was allowed) were excluded.

Double-blind.

Single center; National Institute of Respiratory Diseases (INER), Mexico.

In the register, PE was the rate of symptomatic COVID-19 infection. All subjects were asked to report their symptoms daily via an online survey, with reminders and links being sent with a popular phone application (WhatsApp) to the phone number provided in the baseline evaluation. Subjects were also encouraged to contact the research team directly in case of a probable COVID-19 or adverse event symptom. A new RT-PCR for SARS-COV-2 was performed if subjects presented with COVID19 symptoms.

Study failed to complete estimated sample size. Trial was suspended due to a drastic reduction of recruitment rythm and a lack of benefit of hydroxychloroquine reported from other trials.

PATCH-cohort 3 PreP (Abella), 2020 NCT04329923

hydroxychloroquine (n=66) vs. placebo (n=66)

randomized controlled trial

hydroxychloroquine
600 mg once a day for 2 months

placebo

COVID-19 prophylaxis (excluding children)

double blind

2 tertiary urban hospitals,USA

early termination for futility

early termination for futility

Barnabas RV, 2020 NCT04328961

hydroxychloroquine (n=407) vs. placebo (n=422)

randomized controlled trial

hydroxychloroquine
hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for 11 days

placebo
ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days

prophylaxis

COVID-19 prophylaxis (excluding children)

close contact defined as: household contact, medical staff who cared for the index case without personal protectionaccess to device and internet for telehealth visits are require

single blind

7 centres, USA

pharmacist was unblinded, but the participants, investigators, laboratory technicians, and study team members were blinded to participant allocation

BCN PEP-CoV-2-Study 1 (Mitja NEJM), 2020 NCT04304053

hydroxychloroquine (n=1116) vs. standard of care (n=1198)

randomized controlled trial

hydroxychloroquine 800mg once, followed by 400mg daily for 6 days

standard of care

COVID-19 prophylaxis (excluding children)

open-label

Catalonia, Spain