HYDROXYCHLOROQUINE FOR THE TREATMENT OF SEVERE RESPIRATORY INFECTION BY COVID-19: A RANDOMIZED CONTROLLED TRIAL

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

Clinical characteristics and outcomes of patients with COVID-19 and ARDS admitted to a third level health institution in Mexico City

BackgroundIn December 2019, the first cases of severe pneumonia associated with a new coronavirus were reported in Wuhan, China. Severe respiratory failure requiring intensive care was reported in up to 5% of cases. There is, however, limited information available in Mexico. ObjectivesThe purpose of this study was to describe the clinical manifestations, and outcomes in a COVID-19 cohort attended to from March to May 2020 in our RICU. In addition, we explored the association of clinical variables with mortality. MethodsThe first consecutive patients admitted to the RICU from March 3, 2020, to Jun 24, 2020, with confirmed COVID-19 were investigated. Clinical and laboratory data were obtained. Odds ratios (ORs) were calculated using a logistic regression model. The survival endpoint was mortality at discharge from the RICU. ResultsData from 68 consecutive patients were analyzed. Thirty-eight patients survived, and 30 died (mortality: 44.1 %). Of the 16 predictive variables analyzed, only 6 remained significant in the multivariate analysis [OR (95% confidence interval)]: no acute kidney injury (AKI)/AKI 1: [.61 (.001;.192)]; delta lymphocyte count: [.061 (.006;.619)]; delta ventilatory ratio: [8.19 (1.40;47.8)]; norepinephrine support at admission: [34.3 (2.1;550)]; body mass index: [1.41 (1.09;1.83)]; and bacterial coinfection: [18.5 (1.4;232)]. ConclusionsWe report the characteristics and outcome of patients with ARDS and COVID-19. We found six independent factors associated with the mortality risk: delta lymphocyte count, delta ventilatory ratio, BMI, norepinephrine support, no AKI/AKI 1, and bacterial coinfection.