Covid-19 Living Data

Trial N/A
Publication Mahevas M, BMJ, 2020
Dates: 12-mars-20 to 31-mars-20

Methods
	Non-randomized study
	Location : Multicenter / France Follow-up duration (days): 21
Inclusion criteria	Patients were eligible for this study if they were aged 18-80 years, had PCR confirmed SARS-CoV-2 infection, and required oxygen by mask or nasal prongs (corresponding to a WHO progression score of 5)
Exclusion criteria	Exclusion criteria were the presence of a contraindication to hydroxychloroquine at 600 mg/day (including patients receiving dialysis); hydroxychloroquine treatment started before admission to hospital; treatment with another experimental drug for covid-19 (tocilizumab, lopinavir-ritonavir, or remdesivir) within 48 hours after admission; organ failure that required immediate admission to the intensive care unit or continuous care unit; acute respiratory distress syndrome at admission (defined by the need for non-invasive ventilation with provision of continuous positive airway pressure or invasive mechanical ventilation); discharge from the intensive care unit to standard care; decision to limit and stop active treatments prescribed at admission; and opposition to data collection by patients or their legal representative.
Type of analysis	Propensity score inverse probability weighting
Interventions
	Treatment Hydroxychloroquine (600mg) Co-Intervention: Standard care
	Control Standard care Definition of Standard care: *
Participants
	N analyzed 181 participants (n₁=84 / n₂= 97)
	Characteristics of participants N=181 Mean age : NR 125 males Severity : Mild: n=0 / Moderate: n=173/ Severe: n=0 Critical: n=0
Primary outcome
	In the register NR
	In the report Transfer to the ICU within 21 days of inclusion and/or death from any cause (composite outcome)
Documents avalaible	Protocol No Statistical plan No 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	Moderate
Notes	This is an emulated trial. No registration or protocol were available. The study compares initiation of HCQ within 48 hours of admission, against no initiation within 48 hours of admission. Patients in both arms were cared for in four hospitals in France. We therefore extracted 'standard care' as present in both arms.