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The novel coronavirus pandemic (COVID-19) represents a major public health problem due to its rapid spread and its ability to generate severe pneumonia. Thus, it is essential to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo. Material and methodsA double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary

outcomes:

days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events. ResultsA total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% {+/-} 20, tachycardic (pulse rate 108{+/-}17 min-1) and tachypneic (32 {+/-}10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51-1.53). In the surviving participants, no significant difference was found in secondary outcomes. ConclusionNo beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19. CONSORT GUIDELINES O_TBL View this table org.highwire.dtl.DTLVardef@c46418org.highwire.dtl.DTLVardef@1877269org.highwire.dtl.DTLVardef@1685cb1org.highwire.dtl.DTLVardef@9d8b09org.highwire.dtl.DTLVardef@11339bc_HPS_FORMAT_FIGEXP M_TBL C_TBL