Trial NCT04328961
Publication Barnabas R, Ann Intern Med, 2020
Dates: 3/31/2020 to 8/21/2020
Funding: Mixed (The Bill & Melinda Gates Foundation; Sandoz (drug donation))
Conflict of interest:

Methods
RCT
Location : Multicenter / USA
Follow-up duration (days): 28
Inclusion criteriaMen or women 18 to 80 years of age inclusive, at the time of signing the informed consent;
Willing and able to provide informed consent;
Less than 4 days since last exposure (close contact with a person with SARS‐CoV‐2 infection) to the index case;
Access to device and internet for Telehealth visits;
Not planning to take HCQ in addition to the study medication;
Had a close contact of a person (index) with known PCR‐confirmed SARS‐CoV‐2 infection or index who is currently being assessed for COVID‐19.
Close contact is defined as:
a. Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)
b. Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
Exclusion criteriaKnown hypersensitivity to HCQ or other 4‐aminoquinoline compounds;
Currently hospitalized;
Symptomatic with subjective fever, cough, or shortness of breath;
Current medications exclude concomitant use of HCQ;
Concomitant use of other anti‐malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine;
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, amiodarone, or tamoxifen;
Known moderate or severe liver disease;
Known long QT syndrome;
Severe renal impairment;
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
Interventions
Treatment
Hydroxychloroquine (200 mg* OD) Duration : 14 days
Control
Placebo
Duration : 14 days
Participants
Randomized
829 participants (n1=407 / n2= 422)
Characteristics of participants
N=829
Mean age : NR
277 males
Primary outcome
In the register
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days
In the report
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the supplementary materials, study registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. There were no substantive differences between the published article and the study registry, protocol and statistical analysis plan in population, procedures, interventions or outcomes. The study did not achieve its pre-stated sample size because the Data Safety and Monitoring Board recommend that recruitment be endpoint-driven, stopping when a prespecified number of events were observed.
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