Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2020 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/43042 |
Resumo: | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil. |
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Jeronimo, Christiane Maria PradoFarias, Maria Eduarda LeãoVal, Fernando Fonseca AlmeidaSampaio, Vanderson SouzaAlexandre, Marcia Almeida AraújoMelo, Gisely CardosoSafe, Izabella PicininBorba, Mayla Gabriela SilvaAbreu-Netto, Rebeca LinharesMaciel, Alex Bezerra SilvaNeto, João Ricardo SilvaOliveira, Lucas BarbosaFigueiredo, Erick Frota GomesDinelly, Kelry Mazurega OliveiraRodrigues, Maria Gabriela de AlmeidaBrito, MarceloMourão, Maria Paula GomesPivoto-João, Guilherme AugustoHajjar, Ludhmila AbrahãoBassat, QuiqueRomero, Gustavo Adolfo SierraNaveca, Felipe GomesVasconcelos, Heline LiraTavares, Michel de AraújoBrito-Sousa, José DiegoCosta, Fabio Trindade MaranhãoNogueira, Maurício LacerdaBaía-da-Silva, DjaneXavier, Mariana SimãoMonteiro, Wuelton MarceloLacerda, Marcus Vinícius Guimarãesthe Metcovid Team2020-08-27T20:43:45Z2020-08-27T20:43:45Z2020JERONIMO, Christiane Maria Prado et al. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial. Clinical Infectious Diseases, p. 1-35, 2020.1058-4838https://www.arca.fiocruz.br/handle/icict/4304210.1093/cid/ciaa11771537-6591engMethylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil / Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil / Fundação de Vigilância em Saúde do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Universidade de São Paulo. Faculdade de Medicina. São Paulo, SP, Brasil.Hospital Clínic-Universitat de Barcelona. ISGlobal. Barcelona, Spain / Centro de Investigação em Saúde de Manhiça. Maputo, Mozambique / ICREA. Barcelona, Spain / University of Barcelona. Hospital Sant Joan de Dé. Pediatrics Department. Pediatric Infectious Diseases Unit. Barcelona, Spain / Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública. Madrid, Spain.Universidade de Brasília. Núcleo de Medicina Tropical. Brasília, DF, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Universidade Federal do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Universidade Estadual de Campinas. Campinas, SP, Brasil.Faculdade de Medicina de São José do Rio Preto. São José do Rio Preto, SP, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil / Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Background: Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. Methods: Parallel, double-blind, placebo-controlled, randomized, phase IIb clinical trial was performed with hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution), twice daily, for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. ClinicalTrials Identifier NCT04343729. Findings: From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years in the MP group had a lower mortality rate at day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7. Conclusion: The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population.COVID-19CoronavirusSARS-CoV-2CorticosteroidInflammationBrazilinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83097https://www.arca.fiocruz.br/bitstream/icict/43042/1/license.txt73c2438d9038594f05d706f987b602c3MD51ORIGINALJeronimo_Christiane_etal_INI_2020_COVID-19.pdfJeronimo_Christiane_etal_INI_2020_COVID-19.pdfapplication/pdf1317198https://www.arca.fiocruz.br/bitstream/icict/43042/2/Jeronimo_Christiane_etal_INI_2020_COVID-19.pdf71ce54bcaa0e77f8f95ebbac4988345fMD52TEXTJeronimo_Christiane_etal_INI_2020_COVID-19.pdf.txtJeronimo_Christiane_etal_INI_2020_COVID-19.pdf.txtExtracted 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| dc.title.pt_BR.fl_str_mv |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| title |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| spellingShingle |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial Jeronimo, Christiane Maria Prado COVID-19 Coronavirus SARS-CoV-2 Corticosteroid Inflammation Brazil |
| title_short |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| title_full |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| title_fullStr |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| title_full_unstemmed |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| title_sort |
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial |
| author |
Jeronimo, Christiane Maria Prado |
| author_facet |
Jeronimo, Christiane Maria Prado Farias, Maria Eduarda Leão Val, Fernando Fonseca Almeida Sampaio, Vanderson Souza Alexandre, Marcia Almeida Araújo Melo, Gisely Cardoso Safe, Izabella Picinin Borba, Mayla Gabriela Silva Abreu-Netto, Rebeca Linhares Maciel, Alex Bezerra Silva Neto, João Ricardo Silva Oliveira, Lucas Barbosa Figueiredo, Erick Frota Gomes Dinelly, Kelry Mazurega Oliveira Rodrigues, Maria Gabriela de Almeida Brito, Marcelo Mourão, Maria Paula Gomes Pivoto-João, Guilherme Augusto Hajjar, Ludhmila Abrahão Bassat, Quique Romero, Gustavo Adolfo Sierra Naveca, Felipe Gomes Vasconcelos, Heline Lira Tavares, Michel de Araújo Brito-Sousa, José Diego Costa, Fabio Trindade Maranhão Nogueira, Maurício Lacerda Baía-da-Silva, Djane Xavier, Mariana Simão Monteiro, Wuelton Marcelo Lacerda, Marcus Vinícius Guimarães the Metcovid Team |
| author_role |
author |
| author2 |
Farias, Maria Eduarda Leão Val, Fernando Fonseca Almeida Sampaio, Vanderson Souza Alexandre, Marcia Almeida Araújo Melo, Gisely Cardoso Safe, Izabella Picinin Borba, Mayla Gabriela Silva Abreu-Netto, Rebeca Linhares Maciel, Alex Bezerra Silva Neto, João Ricardo Silva Oliveira, Lucas Barbosa Figueiredo, Erick Frota Gomes Dinelly, Kelry Mazurega Oliveira Rodrigues, Maria Gabriela de Almeida Brito, Marcelo Mourão, Maria Paula Gomes Pivoto-João, Guilherme Augusto Hajjar, Ludhmila Abrahão Bassat, Quique Romero, Gustavo Adolfo Sierra Naveca, Felipe Gomes Vasconcelos, Heline Lira Tavares, Michel de Araújo Brito-Sousa, José Diego Costa, Fabio Trindade Maranhão Nogueira, Maurício Lacerda Baía-da-Silva, Djane Xavier, Mariana Simão Monteiro, Wuelton Marcelo Lacerda, Marcus Vinícius Guimarães the Metcovid Team |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Jeronimo, Christiane Maria Prado Farias, Maria Eduarda Leão Val, Fernando Fonseca Almeida Sampaio, Vanderson Souza Alexandre, Marcia Almeida Araújo Melo, Gisely Cardoso Safe, Izabella Picinin Borba, Mayla Gabriela Silva Abreu-Netto, Rebeca Linhares Maciel, Alex Bezerra Silva Neto, João Ricardo Silva Oliveira, Lucas Barbosa Figueiredo, Erick Frota Gomes Dinelly, Kelry Mazurega Oliveira Rodrigues, Maria Gabriela de Almeida Brito, Marcelo Mourão, Maria Paula Gomes Pivoto-João, Guilherme Augusto Hajjar, Ludhmila Abrahão Bassat, Quique Romero, Gustavo Adolfo Sierra Naveca, Felipe Gomes Vasconcelos, Heline Lira Tavares, Michel de Araújo Brito-Sousa, José Diego Costa, Fabio Trindade Maranhão Nogueira, Maurício Lacerda Baía-da-Silva, Djane Xavier, Mariana Simão Monteiro, Wuelton Marcelo Lacerda, Marcus Vinícius Guimarães the Metcovid Team |
| dc.subject.en.pt_BR.fl_str_mv |
COVID-19 Coronavirus SARS-CoV-2 Corticosteroid Inflammation Brazil |
| topic |
COVID-19 Coronavirus SARS-CoV-2 Corticosteroid Inflammation Brazil |
| description |
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil. |
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2020 |
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2020-08-27T20:43:45Z |
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2020-08-27T20:43:45Z |
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2020 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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JERONIMO, Christiane Maria Prado et al. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial. Clinical Infectious Diseases, p. 1-35, 2020. |
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https://www.arca.fiocruz.br/handle/icict/43042 |
| dc.identifier.issn.pt_BR.fl_str_mv |
1058-4838 |
| dc.identifier.doi.pt_BR.fl_str_mv |
10.1093/cid/ciaa1177 |
| dc.identifier.eissn.pt_BR.fl_str_mv |
1537-6591 |
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JERONIMO, Christiane Maria Prado et al. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial. Clinical Infectious Diseases, p. 1-35, 2020. 1058-4838 10.1093/cid/ciaa1177 1537-6591 |
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https://www.arca.fiocruz.br/handle/icict/43042 |
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eng |
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Repositório Institucional da FIOCRUZ (ARCA) |
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https://www.arca.fiocruz.br/bitstream/icict/43042/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/43042/2/Jeronimo_Christiane_etal_INI_2020_COVID-19.pdf https://www.arca.fiocruz.br/bitstream/icict/43042/3/Jeronimo_Christiane_etal_INI_2020_COVID-19.pdf.txt |
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MD5 MD5 MD5 |
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Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ) |
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repositorio.arca@fiocruz.br |
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1813009002856972288 |