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

<h4>Introduction</h4>The novel coronavirus pandemic (COVID-19) represents a major public health problem and it is key 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 mortalit...

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Autores principales:	Carmen Hernandez-Cardenas, Ireri Thirion-Romero, Sebastián Rodríguez-Llamazares, Norma E Rivera-Martinez, Patricia Meza-Meneses, Arantxa Remigio-Luna, Rogelio Perez-Padilla, Research Group on hydroxychloroquine for COVID-19
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/865a4ab2b6794dd8b110faeb5370270f
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spelling	oai:doaj.org-article:865a4ab2b6794dd8b110faeb5370270f2021-11-25T06:19:00ZHydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.1932-620310.1371/journal.pone.0257238https://doaj.org/article/865a4ab2b6794dd8b110faeb5370270f2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0257238https://doaj.org/toc/1932-6203<h4>Introduction</h4>The novel coronavirus pandemic (COVID-19) represents a major public health problem and it is key 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.<h4>Material and methods</h4>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.<h4>Results</h4>A 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.<h4>Conclusion</h4>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.Carmen Hernandez-CardenasIreri Thirion-RomeroSebastián Rodríguez-LlamazaresNorma E Rivera-MartinezPatricia Meza-MenesesArantxa Remigio-LunaRogelio Perez-PadillaResearch Group on hydroxychloroquine for COVID-19Public Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 9, p e0257238 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Carmen Hernandez-Cardenas Ireri Thirion-Romero Sebastián Rodríguez-Llamazares Norma E Rivera-Martinez Patricia Meza-Meneses Arantxa Remigio-Luna Rogelio Perez-Padilla Research Group on hydroxychloroquine for COVID-19 Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.
description	<h4>Introduction</h4>The novel coronavirus pandemic (COVID-19) represents a major public health problem and it is key 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.<h4>Material and methods</h4>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.<h4>Results</h4>A 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.<h4>Conclusion</h4>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.
format	article
author	Carmen Hernandez-Cardenas Ireri Thirion-Romero Sebastián Rodríguez-Llamazares Norma E Rivera-Martinez Patricia Meza-Meneses Arantxa Remigio-Luna Rogelio Perez-Padilla Research Group on hydroxychloroquine for COVID-19
author_facet	Carmen Hernandez-Cardenas Ireri Thirion-Romero Sebastián Rodríguez-Llamazares Norma E Rivera-Martinez Patricia Meza-Meneses Arantxa Remigio-Luna Rogelio Perez-Padilla Research Group on hydroxychloroquine for COVID-19
author_sort	Carmen Hernandez-Cardenas
title	Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.
title_short	Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.
title_full	Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.
title_fullStr	Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.
title_full_unstemmed	Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.
title_sort	hydroxychloroquine for the treatment of severe respiratory infection by covid-19: a randomized controlled trial.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/865a4ab2b6794dd8b110faeb5370270f
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Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial.

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