Covid-19 Living Data

Trial NCT04331834
Publication Grau-Pujol B, Research Square, 2020
Dates: 4/4/2020 to 6/12/2020
Funding: Mixed (ISGlobal; Hospital Clinic's International Health's department; Laboratorios Rubio)
Conflict of interest: No conflicts of interest

Methods
	RCT
	Location : Multicenter / Spain Follow-up duration (days): 30
Inclusion criteria	Adult healthcare workers working at least three days a week in a trial hospital with a negative result of SARS-CoV-2 polymerase chain reaction (PCR) assay in nasopharyngeal swab within four days before enrolment. COVID-19 serology was evaluated in all candidates with a rapid diagnostic test (Vivadiag COVID-19 IgM/IgG Rapid Test ©, Hangzhou, China) and confirmed with Enzyme-Linked ImmunoSorbent Assays (VITROS Anti-SARS-CoV-2 Total, © Ortho-Clinical Diagnostics, 2020).
Exclusion criteria	Positive for COVID-19 serology by any method; pregnancy, breastfeeding; ongoing antiviral, antiretroviral or corticosteroids treatment; chloroquine or hydroxychloroquine intake the last month or any contraindication to hydroxychloroquine.
Interventions
	Treatment Hydroxychloroquine (*) Duration : 6 months
	Control Placebo Duration : 6 months
Participants
	Randomized 269 participants (n₁=142 / n₂= 127)
	Characteristics of participants N=269 Mean age : 39.9 72 males
Primary outcome
	In the register Confirmed cases of a COVID-19 [ Time Frame: Up to 6 months after start of treatment]
	In the report
Documents available	Protocol Yes 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	High
General comment	In addition to the pre-print study report, the trial registration, published structured summary of the protocol and the full trial protocol were used in data extraction and risk of bias assessment. There was no change from the trial registration in the intervention and control treatments nor in the outcomes. The study did not achieve its planned sample size because after the first planned monthly interim analysis the trial was halted on the basis of a very low incidence rate among study participants. Five participants discontinued the prophylaxis due to adverse events in the hydroxychloroquine group and one in the placebo group.