Trial NCT04334148
Publication Naggie S (COI)
Dates: 4/22/2020 to 11/30/2020
Funding: Public/nonprofit (Patient-Centered Outcomes Research Institute (PCORI))
Conflict of interest:

Methods
RCT
Blinding:
Location : Multicenter / USA
Follow-up duration (days): 60
Inclusion criteriaProvided informed consent; age 18 or older; working in a health care setting with potential exposure to patients with COVID-19
Exclusion criteriaPrior diagnosis of COVID-19 infection; contraindications to HCQ
Interventions
Treatment
Hydroxychloroquine (*) Duration : 30 days
Control
Placebo
Duration : 30 days
Participants
Randomized
1360 participants (n1=683 / n2= 677)
Characteristics of participants
N=1360
Mean age : 43.65
471 males
Primary outcome
In the register
Number of participants with clinical infection with COVID-19 infection [ Time Frame: 30 days ]
In the report
Confirmed or suspected clinical infection with COVID19 through 30 days
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 pre-print article, the prospective trial registry, protocol (Version 3.0) and supplementary files were used in data extraction and assessment of risk of bias. The primary and secondary outcome reported reflect those in the registry. Exploratory outcomes reported in the article (SARS-CoV-2 nucleocapsid IgG seroconversion, COVID-19 complications, days sick or lost work time, self-reported health and well-being, professional burnout, clinical infections among household contacts and other impacts on household) were not included in the registry. The trial (n = 1360) did not achieve its original (n = 15000) or amended (n = 2000) target sample size due because it was stopped early due to failure to enroll. Thus the study was underpowered to answer the question about efficacy of HCQ for prophylactic benefit for SARS-CoV-1. The study did not have frequent PCR testing, this resulted in few confirmed COVID-19 infections and suspected cases were combined with confirmed cases in the primary outcome.