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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2021
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.
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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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