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Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection
Objective: Given the urgent need for strategies to minimize the damage caused by this pandemic, this study performed a randomized, double-blind phase 2 study to assess the safety of the effectiveness of chloroquine (CQ), hydroxychloroquine (HCQ) or ivermectin in severe forms of COVID-19, in addition...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938655/ https://www.ncbi.nlm.nih.gov/pubmed/33682640 http://dx.doi.org/10.1080/20477724.2021.1890887 |
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author | Galan, Luis Enrique Bermejo dos Santos, Nayara Melo Asato, Mauro Shosuka Araújo, Jucineide Vieira de Lima Moreira, Adriana Araújo, Aléxia Mahara Marques Paiva, Artur Diogenes Pinheiro Portella, Diego Guilherme Santos Marques, Frank Silas Saldanha Silva, Gabriel Melo Alexandre de Sousa Resende, Joana Tizolim, Marycassiely Rodrigues Santos, Poliana Lucenados Buttenbender, Steffi Ferreira de Andrade, Stephanye Batista Carbonell, Roberto Carlos Cruz Da Rocha, Juliana Gomes de Souza, Ruy Guilherme Silveira da Fonseca, Allex Jardim |
author_facet | Galan, Luis Enrique Bermejo dos Santos, Nayara Melo Asato, Mauro Shosuka Araújo, Jucineide Vieira de Lima Moreira, Adriana Araújo, Aléxia Mahara Marques Paiva, Artur Diogenes Pinheiro Portella, Diego Guilherme Santos Marques, Frank Silas Saldanha Silva, Gabriel Melo Alexandre de Sousa Resende, Joana Tizolim, Marycassiely Rodrigues Santos, Poliana Lucenados Buttenbender, Steffi Ferreira de Andrade, Stephanye Batista Carbonell, Roberto Carlos Cruz Da Rocha, Juliana Gomes de Souza, Ruy Guilherme Silveira da Fonseca, Allex Jardim |
author_sort | Galan, Luis Enrique Bermejo |
collection | PubMed |
description | Objective: Given the urgent need for strategies to minimize the damage caused by this pandemic, this study performed a randomized, double-blind phase 2 study to assess the safety of the effectiveness of chloroquine (CQ), hydroxychloroquine (HCQ) or ivermectin in severe forms of COVID-19, in addition to identifying predictors of mortality in this group of patients. Methods: Phase 2, double-blind, randomized study to assess the safety and efficacy of enteral CQ, HCQ or ivermectin in patients hospitalized for SARS-CoV-2 infection, admitted to a Reference Hospital in Roraima (Brazil) in may 2020. Patients were randomized in a 1:1:1 ratio. The endpoints were need of supplemental O(2), invasive ventilation, admission in ICU and death. The study was approved by an independent IRB. Results: 168 patients were randomized. The mean age was 53.4 years (±15.6), most participants were male (n = 95; 58.2%). Therapy with corticosteroid, anticoagulant or antibiotics was a decision of the attending physicians, and there was no difference between the groups. The mortality was similar in three groups (22.2%; 21.3% and 23.0%) suggesting ineffectiveness of the drugs. No difference in the incidence of serious adverse events were observed. To be older than 60 years of age, obesity, diabetes, extensive pulmonary involvement and low SaO(2) at hospital admission due to independent risk factors for mortality. Conclusion: Although CQ, HCQ or ivermectin revealed a favorable safety profile, the tested drugs do not reduce the need for supplemental oxygen, ICU admission, invasive ventilation or death, in patients hospitalized with a severe form of COVID-19. |
format | Online Article Text |
id | pubmed-7938655 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Taylor & Francis |
record_format | MEDLINE/PubMed |
spelling | pubmed-79386552021-03-08 Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection Galan, Luis Enrique Bermejo dos Santos, Nayara Melo Asato, Mauro Shosuka Araújo, Jucineide Vieira de Lima Moreira, Adriana Araújo, Aléxia Mahara Marques Paiva, Artur Diogenes Pinheiro Portella, Diego Guilherme Santos Marques, Frank Silas Saldanha Silva, Gabriel Melo Alexandre de Sousa Resende, Joana Tizolim, Marycassiely Rodrigues Santos, Poliana Lucenados Buttenbender, Steffi Ferreira de Andrade, Stephanye Batista Carbonell, Roberto Carlos Cruz Da Rocha, Juliana Gomes de Souza, Ruy Guilherme Silveira da Fonseca, Allex Jardim Pathog Glob Health Research Article Objective: Given the urgent need for strategies to minimize the damage caused by this pandemic, this study performed a randomized, double-blind phase 2 study to assess the safety of the effectiveness of chloroquine (CQ), hydroxychloroquine (HCQ) or ivermectin in severe forms of COVID-19, in addition to identifying predictors of mortality in this group of patients. Methods: Phase 2, double-blind, randomized study to assess the safety and efficacy of enteral CQ, HCQ or ivermectin in patients hospitalized for SARS-CoV-2 infection, admitted to a Reference Hospital in Roraima (Brazil) in may 2020. Patients were randomized in a 1:1:1 ratio. The endpoints were need of supplemental O(2), invasive ventilation, admission in ICU and death. The study was approved by an independent IRB. Results: 168 patients were randomized. The mean age was 53.4 years (±15.6), most participants were male (n = 95; 58.2%). Therapy with corticosteroid, anticoagulant or antibiotics was a decision of the attending physicians, and there was no difference between the groups. The mortality was similar in three groups (22.2%; 21.3% and 23.0%) suggesting ineffectiveness of the drugs. No difference in the incidence of serious adverse events were observed. To be older than 60 years of age, obesity, diabetes, extensive pulmonary involvement and low SaO(2) at hospital admission due to independent risk factors for mortality. Conclusion: Although CQ, HCQ or ivermectin revealed a favorable safety profile, the tested drugs do not reduce the need for supplemental oxygen, ICU admission, invasive ventilation or death, in patients hospitalized with a severe form of COVID-19. Taylor & Francis 2021-03-08 /pmc/articles/PMC7938655/ /pubmed/33682640 http://dx.doi.org/10.1080/20477724.2021.1890887 Text en © 2021 Informa UK Limited, trading as Taylor & Francis Group |
spellingShingle | Research Article Galan, Luis Enrique Bermejo dos Santos, Nayara Melo Asato, Mauro Shosuka Araújo, Jucineide Vieira de Lima Moreira, Adriana Araújo, Aléxia Mahara Marques Paiva, Artur Diogenes Pinheiro Portella, Diego Guilherme Santos Marques, Frank Silas Saldanha Silva, Gabriel Melo Alexandre de Sousa Resende, Joana Tizolim, Marycassiely Rodrigues Santos, Poliana Lucenados Buttenbender, Steffi Ferreira de Andrade, Stephanye Batista Carbonell, Roberto Carlos Cruz Da Rocha, Juliana Gomes de Souza, Ruy Guilherme Silveira da Fonseca, Allex Jardim Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection |
title | Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection |
title_full | Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection |
title_fullStr | Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection |
title_full_unstemmed | Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection |
title_short | Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection |
title_sort | phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of sars-cov-2 infection |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938655/ https://www.ncbi.nlm.nih.gov/pubmed/33682640 http://dx.doi.org/10.1080/20477724.2021.1890887 |
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