Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: a randomized controlled trial

{ 'institution': [{'name': 'medRxiv'}], 'indexed': {'date-parts': [[2024, 3, 1]], 'date-time': '2024-03-01T23:36:09Z', 'timestamp': 1709336169354}, 'posted': {'date-parts': [[2021, 2, 5]]}, 'group-title': 'Respiratory Medicine', 'reference-count': 17, 'publisher': 'Cold Spring Harbor Laboratory', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'accepted': {'date-parts': [[2021, 2, 5]]}, 'abstract': '<jats:title>ABSTRACT</jats:title><jats:p>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.</jats:p><jats:sec><jats:title>Material and methods</jats:title><jats:p>A ' '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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 214 ' 'patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a ' 'mean SpO<jats:sub>2</jats:sub> of 65% ± 20, tachycardic (pulse rate 108±17 ' 'min-<jats:sup>1</jats:sup>) and tachypneic (32 ±10 min-<jats:sup>1</jats:sup>); 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>No ' '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.</jats:p></jats:sec><jats:sec><jats:title>CONSORT ' 'GUIDELINES</jats:title><jats:table-wrap id="utbl1" orientation="portrait" ' 'position="float"><jats:graphic xmlns:xlink="http://www.w3.org/1999/xlink" ' 'xlink:href="21250371v1_utbl1" position="float" orientation="portrait" ' '/></jats:table-wrap></jats:sec>', 'DOI': '10.1101/2021.02.01.21250371', 'type': 'posted-content', 'created': {'date-parts': [[2021, 2, 5]], 'date-time': '2021-02-05T21:20:16Z', 'timestamp': 1612560016000}, 'source': 'Crossref', 'is-referenced-by-count': 4, 'title': 'HYDROXYCHLOROQUINE FOR THE TREATMENT OF SEVERE RESPIRATORY INFECTION BY COVID-19: A RANDOMIZED ' 'CONTROLLED TRIAL', 'prefix': '10.1101', 'author': [ {'given': 'Carmen', 'family': 'Hernandez-Cardenas', 'sequence': 'first', 'affiliation': []}, {'given': 'Ireri', 'family': 'Thirion-Romero', 'sequence': 'additional', 'affiliation': []}, {'given': 'Norma E.', 'family': 'Rivera-Martinez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Patricia', 'family': 'Meza-Meneses', 'sequence': 'additional', 'affiliation': []}, {'given': 'Arantxa', 'family': 'Remigio-Luna', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rogelio', 'family': 'Perez-Padilla', 'sequence': 'additional', 'affiliation': []}], 'member': '246', 'reference': [ { 'key': '2021020706551270000_2021.02.01.21250371v1.1', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S0140-6736(20)30154-9'}, { 'key': '2021020706551270000_2021.02.01.21250371v1.2', 'doi-asserted-by': 'crossref', 'unstructured': 'Chen N , Zhou M , Dong X , et al. 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