Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection.
Identifieur interne : 000273 ( Main/Exploration ); précédent : 000272; suivant : 000274Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection.
Auteurs : Luis Enrique Bermejo Galan [Brésil] ; Nayara Melo Dos Santos ; Mauro Shosuka Asato ; Jucineide Vieira Araújo [Brésil] ; Adriana De Lima Moreira [Brésil] ; Aléxia Mahara Marques Araújo [Brésil] ; Artur Diogenes Pinheiro Paiva [Brésil] ; Diego Guilherme Santos Portella [Brésil] ; Frank Silas Saldanha Marques [Brésil] ; Gabriel Melo Alexandre Silva [Brésil] ; Joana De Sousa Resende [Brésil] ; Marycassiely Rodrigues Tizolim [Brésil] ; Poliana Lucenados Santos [Brésil] ; Steffi Ferreira Buttenbender [Brésil] ; Stephanye Batista De Andrade [Brésil] ; Roberto Carlos Cruz Carbonell [Brésil] ; Juliana Gomes Da Rocha ; Ruy Guilherme Silveira De Souza [Brésil] ; Allex Jardim Da Fonseca [Brésil]Source :
- Pathogens and global health [ 2047-7732 ] ; 2021.
Abstract
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 O2, 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 SaO2 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.
DOI: 10.1080/20477724.2021.1890887
PubMed: 33682640
PubMed Central: PMC7938655
Affiliations:
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Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Portella, Diego Guilherme Santos" sort="Portella, Diego Guilherme Santos" uniqKey="Portella D" first="Diego Guilherme Santos" last="Portella">Diego Guilherme Santos Portella</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Marques, Frank Silas Saldanha" sort="Marques, Frank Silas Saldanha" uniqKey="Marques F" first="Frank Silas Saldanha" last="Marques">Frank Silas Saldanha Marques</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Silva, Gabriel Melo Alexandre" sort="Silva, Gabriel Melo Alexandre" uniqKey="Silva G" first="Gabriel Melo Alexandre" last="Silva">Gabriel Melo Alexandre Silva</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="De Sousa Resende, Joana" sort="De Sousa Resende, Joana" uniqKey="De Sousa Resende J" first="Joana" last="De Sousa Resende">Joana De Sousa Resende</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Tizolim, Marycassiely Rodrigues" sort="Tizolim, Marycassiely Rodrigues" uniqKey="Tizolim M" first="Marycassiely Rodrigues" last="Tizolim">Marycassiely Rodrigues Tizolim</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Santos, Poliana Lucenados" sort="Santos, Poliana Lucenados" uniqKey="Santos P" first="Poliana Lucenados" last="Santos">Poliana Lucenados Santos</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Buttenbender, Steffi Ferreira" sort="Buttenbender, Steffi Ferreira" uniqKey="Buttenbender S" first="Steffi Ferreira" last="Buttenbender">Steffi Ferreira Buttenbender</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="De Andrade, Stephanye Batista" sort="De Andrade, Stephanye Batista" uniqKey="De Andrade S" first="Stephanye Batista" last="De Andrade">Stephanye Batista De Andrade</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Carbonell, Roberto Carlos Cruz" sort="Carbonell, Roberto Carlos Cruz" uniqKey="Carbonell R" first="Roberto Carlos Cruz" last="Carbonell">Roberto Carlos Cruz Carbonell</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Da Rocha, Juliana Gomes" sort="Da Rocha, Juliana Gomes" uniqKey="Da Rocha J" first="Juliana Gomes" last="Da Rocha">Juliana Gomes Da Rocha</name><affiliation><nlm:affiliation>Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry></affiliation></author><author><name sortKey="De Souza, Ruy Guilherme Silveira" sort="De Souza, Ruy Guilherme Silveira" uniqKey="De Souza R" first="Ruy Guilherme Silveira" last="De Souza">Ruy Guilherme Silveira De Souza</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Da Fonseca, Allex Jardim" sort="Da Fonseca, Allex Jardim" uniqKey="Da Fonseca A" first="Allex Jardim" last="Da Fonseca">Allex Jardim Da Fonseca</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation><affiliation><nlm:affiliation>Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33682640</idno><idno type="pmid">33682640</idno><idno type="doi">10.1080/20477724.2021.1890887</idno><idno type="pmc">PMC7938655</idno><idno type="wicri:Area/Main/Corpus">000261</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000261</idno><idno type="wicri:Area/Main/Curation">000261</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000261</idno><idno type="wicri:Area/Main/Exploration">000261</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection.</title><author><name sortKey="Galan, Luis Enrique Bermejo" sort="Galan, Luis Enrique Bermejo" uniqKey="Galan L" first="Luis Enrique Bermejo" last="Galan">Luis Enrique Bermejo Galan</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Santos, Nayara Melo Dos" sort="Santos, Nayara Melo Dos" uniqKey="Santos N" first="Nayara Melo Dos" last="Santos">Nayara Melo Dos Santos</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation></author><author><name sortKey="Asato, Mauro Shosuka" sort="Asato, Mauro Shosuka" uniqKey="Asato M" first="Mauro Shosuka" last="Asato">Mauro Shosuka Asato</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation></author><author><name sortKey="Araujo, Jucineide Vieira" sort="Araujo, Jucineide Vieira" uniqKey="Araujo J" first="Jucineide Vieira" last="Araújo">Jucineide Vieira Araújo</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="De Lima Moreira, Adriana" sort="De Lima Moreira, Adriana" uniqKey="De Lima Moreira A" first="Adriana" last="De Lima Moreira">Adriana De Lima Moreira</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Araujo, Alexia Mahara Marques" sort="Araujo, Alexia Mahara Marques" uniqKey="Araujo A" first="Aléxia Mahara Marques" last="Araújo">Aléxia Mahara Marques Araújo</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Paiva, Artur Diogenes Pinheiro" sort="Paiva, Artur Diogenes Pinheiro" uniqKey="Paiva A" first="Artur Diogenes Pinheiro" last="Paiva">Artur Diogenes Pinheiro Paiva</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Portella, Diego Guilherme Santos" sort="Portella, Diego Guilherme Santos" uniqKey="Portella D" first="Diego Guilherme Santos" last="Portella">Diego Guilherme Santos Portella</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Marques, Frank Silas Saldanha" sort="Marques, Frank Silas Saldanha" uniqKey="Marques F" first="Frank Silas Saldanha" last="Marques">Frank Silas Saldanha Marques</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Silva, Gabriel Melo Alexandre" sort="Silva, Gabriel Melo Alexandre" uniqKey="Silva G" first="Gabriel Melo Alexandre" last="Silva">Gabriel Melo Alexandre Silva</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="De Sousa Resende, Joana" sort="De Sousa Resende, Joana" uniqKey="De Sousa Resende J" first="Joana" last="De Sousa Resende">Joana De Sousa Resende</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Tizolim, Marycassiely Rodrigues" sort="Tizolim, Marycassiely Rodrigues" uniqKey="Tizolim M" first="Marycassiely Rodrigues" last="Tizolim">Marycassiely Rodrigues Tizolim</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Santos, Poliana Lucenados" sort="Santos, Poliana Lucenados" uniqKey="Santos P" first="Poliana Lucenados" last="Santos">Poliana Lucenados Santos</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Buttenbender, Steffi Ferreira" sort="Buttenbender, Steffi Ferreira" uniqKey="Buttenbender S" first="Steffi Ferreira" last="Buttenbender">Steffi Ferreira Buttenbender</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="De Andrade, Stephanye Batista" sort="De Andrade, Stephanye Batista" uniqKey="De Andrade S" first="Stephanye Batista" last="De Andrade">Stephanye Batista De Andrade</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Carbonell, Roberto Carlos Cruz" sort="Carbonell, Roberto Carlos Cruz" uniqKey="Carbonell R" first="Roberto Carlos Cruz" last="Carbonell">Roberto Carlos Cruz Carbonell</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Da Rocha, Juliana Gomes" sort="Da Rocha, Juliana Gomes" uniqKey="Da Rocha J" first="Juliana Gomes" last="Da Rocha">Juliana Gomes Da Rocha</name><affiliation><nlm:affiliation>Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry></affiliation></author><author><name sortKey="De Souza, Ruy Guilherme Silveira" sort="De Souza, Ruy Guilherme Silveira" uniqKey="De Souza R" first="Ruy Guilherme Silveira" last="De Souza">Ruy Guilherme Silveira De Souza</name><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation></author><author><name sortKey="Da Fonseca, Allex Jardim" sort="Da Fonseca, Allex Jardim" uniqKey="Da Fonseca A" first="Allex Jardim" last="Da Fonseca">Allex Jardim Da Fonseca</name><affiliation><nlm:affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista</wicri:regionArea><wicri:noRegion>Boa Vista</wicri:noRegion></affiliation><affiliation><nlm:affiliation>Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</nlm:affiliation><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry><wicri:noCountry code="no comma">Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</wicri:noCountry></affiliation></author></analytic><series><title level="j">Pathogens and global health</title><idno type="eISSN">2047-7732</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><b>Objective</b>: 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.<b>Methods</b>: 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<sub>2</sub>, invasive ventilation, admission in ICU and death. The study was approved by an independent IRB.<b>Results</b>: 168 patients were randomized. The mean age was 53.4 years (±15.6), most participants were male (<i>n</i> = 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<sub>2</sub> at hospital admission due to independent risk factors for mortality.<b>Conclusion</b>: 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.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33682640</PMID><DateRevised><Year>2021</Year><Month>05</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2047-7732</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2021</Year><Month>Mar</Month><Day>08</Day></PubDate></JournalIssue><Title>Pathogens and global health</Title><ISOAbbreviation>Pathog Glob Health</ISOAbbreviation></Journal><ArticleTitle>Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection.</ArticleTitle><Pagination><MedlinePgn>1-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/20477724.2021.1890887</ELocationID><Abstract><AbstractText><b>Objective</b>: 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.<b>Methods</b>: 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<sub>2</sub>, invasive ventilation, admission in ICU and death. The study was approved by an independent IRB.<b>Results</b>: 168 patients were randomized. The mean age was 53.4 years (±15.6), most participants were male (<i>n</i> = 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<sub>2</sub> at hospital admission due to independent risk factors for mortality.<b>Conclusion</b>: 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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Galan</LastName><ForeName>Luis Enrique Bermejo</ForeName><Initials>LEB</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Santos</LastName><ForeName>Nayara Melo Dos</ForeName><Initials>NMD</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Asato</LastName><ForeName>Mauro Shosuka</ForeName><Initials>MS</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Araújo</LastName><ForeName>Jucineide Vieira</ForeName><Initials>JV</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Lima Moreira</LastName><ForeName>Adriana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Araújo</LastName><ForeName>Aléxia Mahara Marques</ForeName><Initials>AMM</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paiva</LastName><ForeName>Artur Diogenes Pinheiro</ForeName><Initials>ADP</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Portella</LastName><ForeName>Diego Guilherme Santos</ForeName><Initials>DGS</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marques</LastName><ForeName>Frank Silas Saldanha</ForeName><Initials>FSS</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Silva</LastName><ForeName>Gabriel Melo Alexandre</ForeName><Initials>GMA</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Sousa Resende</LastName><ForeName>Joana</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tizolim</LastName><ForeName>Marycassiely Rodrigues</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Santos</LastName><ForeName>Poliana Lucenados</ForeName><Initials>PL</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buttenbender</LastName><ForeName>Steffi Ferreira</ForeName><Initials>SF</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Andrade</LastName><ForeName>Stephanye Batista</ForeName><Initials>SB</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carbonell</LastName><ForeName>Roberto Carlos Cruz</ForeName><Initials>RCC</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Da Rocha</LastName><ForeName>Juliana Gomes</ForeName><Initials>JG</Initials><AffiliationInfo><Affiliation>Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Souza</LastName><ForeName>Ruy Guilherme Silveira</ForeName><Initials>RGS</Initials><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>da Fonseca</LastName><ForeName>Allex Jardim</ForeName><Initials>AJ</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-1715-5469</Identifier><AffiliationInfo><Affiliation>Department of Infectious Diseases of Hospital Geral De Roraima. Universidade Federal De Roraima. Boa Vista Brazil.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Post Graduate Program in Health Science of Universidade Federal De Roraima, Health Science Center, Boa Vista, Brazil.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Research Center of the Oncological Center of Roraima - Boa Vista - Brazil.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>03</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Pathog Glob Health</MedlineTA><NlmUniqueID>101583421</NlmUniqueID><ISSNLinking>2047-7724</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">chloroquine</Keyword><Keyword MajorTopicYN="N">coronavirus</Keyword><Keyword MajorTopicYN="N">hydroxychloroquine</Keyword><Keyword MajorTopicYN="N">ivermectin</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>3</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>3</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>3</Month><Day>8</Day><Hour>8</Hour><Minute>43</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33682640</ArticleId><ArticleId IdType="doi">10.1080/20477724.2021.1890887</ArticleId><ArticleId IdType="pmc">PMC7938655</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Brésil</li></country></list><tree><noCountry><name sortKey="Asato, Mauro Shosuka" sort="Asato, Mauro Shosuka" uniqKey="Asato M" first="Mauro Shosuka" last="Asato">Mauro Shosuka Asato</name><name sortKey="Da Rocha, Juliana Gomes" sort="Da Rocha, Juliana Gomes" uniqKey="Da Rocha J" first="Juliana Gomes" last="Da Rocha">Juliana Gomes Da Rocha</name><name sortKey="Santos, Nayara Melo Dos" sort="Santos, Nayara Melo Dos" uniqKey="Santos N" first="Nayara Melo Dos" last="Santos">Nayara Melo Dos Santos</name></noCountry><country name="Brésil"><noRegion><name sortKey="Galan, Luis Enrique Bermejo" sort="Galan, Luis Enrique Bermejo" uniqKey="Galan L" first="Luis Enrique Bermejo" last="Galan">Luis Enrique Bermejo Galan</name></noRegion><name sortKey="Araujo, Alexia Mahara Marques" sort="Araujo, Alexia Mahara Marques" uniqKey="Araujo A" first="Aléxia Mahara Marques" last="Araújo">Aléxia Mahara Marques Araújo</name><name sortKey="Araujo, Jucineide Vieira" sort="Araujo, Jucineide Vieira" uniqKey="Araujo J" first="Jucineide Vieira" last="Araújo">Jucineide Vieira Araújo</name><name sortKey="Buttenbender, Steffi Ferreira" sort="Buttenbender, Steffi Ferreira" uniqKey="Buttenbender S" first="Steffi Ferreira" last="Buttenbender">Steffi Ferreira Buttenbender</name><name sortKey="Carbonell, Roberto Carlos Cruz" sort="Carbonell, Roberto Carlos Cruz" uniqKey="Carbonell R" first="Roberto Carlos Cruz" last="Carbonell">Roberto Carlos Cruz Carbonell</name><name sortKey="Da Fonseca, Allex Jardim" sort="Da Fonseca, Allex Jardim" uniqKey="Da Fonseca A" first="Allex Jardim" last="Da Fonseca">Allex Jardim Da Fonseca</name><name sortKey="De Andrade, Stephanye Batista" sort="De Andrade, Stephanye Batista" uniqKey="De Andrade S" first="Stephanye Batista" last="De Andrade">Stephanye Batista De Andrade</name><name sortKey="De Lima Moreira, Adriana" sort="De Lima Moreira, Adriana" uniqKey="De Lima Moreira A" first="Adriana" last="De Lima Moreira">Adriana De Lima Moreira</name><name sortKey="De Sousa Resende, Joana" sort="De Sousa Resende, Joana" uniqKey="De Sousa Resende J" first="Joana" last="De Sousa Resende">Joana De Sousa Resende</name><name sortKey="De Souza, Ruy Guilherme Silveira" sort="De Souza, Ruy Guilherme Silveira" uniqKey="De Souza R" first="Ruy Guilherme Silveira" last="De Souza">Ruy Guilherme Silveira De Souza</name><name sortKey="Marques, Frank Silas Saldanha" sort="Marques, Frank Silas Saldanha" uniqKey="Marques F" first="Frank Silas Saldanha" last="Marques">Frank Silas Saldanha Marques</name><name sortKey="Paiva, Artur Diogenes Pinheiro" sort="Paiva, Artur Diogenes Pinheiro" uniqKey="Paiva A" first="Artur Diogenes Pinheiro" last="Paiva">Artur Diogenes Pinheiro Paiva</name><name sortKey="Portella, Diego Guilherme Santos" sort="Portella, Diego Guilherme Santos" uniqKey="Portella D" first="Diego Guilherme Santos" last="Portella">Diego Guilherme Santos Portella</name><name sortKey="Santos, Poliana Lucenados" sort="Santos, Poliana Lucenados" uniqKey="Santos P" first="Poliana Lucenados" last="Santos">Poliana Lucenados Santos</name><name sortKey="Silva, Gabriel Melo Alexandre" sort="Silva, Gabriel Melo Alexandre" uniqKey="Silva G" first="Gabriel Melo Alexandre" last="Silva">Gabriel Melo Alexandre Silva</name><name sortKey="Tizolim, Marycassiely Rodrigues" sort="Tizolim, Marycassiely Rodrigues" uniqKey="Tizolim M" first="Marycassiely Rodrigues" last="Tizolim">Marycassiely Rodrigues Tizolim</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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