Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial

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art_JERONIMO_Methylprednisolone_as_Adjunctive_Therapy_for_Patients_Hospitalized_With_2021.PDF (1.47 MB)
Citações na Scopus
283
Tipo de produção
article
Data de publicação
2021
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
OXFORD UNIV PRESS INC
Autores
JERONIMO, Christiane Maria Prado
FARIAS, Maria Eduarda Leao
VAL, Fernando Fonseca Almeida
SAMPAIO, Vanderson Souza
ALEXANDRE, Marcia Almeida Araujo
MELO, Gisely Cardoso
SAFE, Izabella Picinin
BORBA, Mayla Gabriela Silva
ABREU NETTO, Rebeca Linhares
MACIEL, Alex Bezerra Silva
Citação
CLINICAL INFECTIOUS DISEASES, v.72, n.9, p.E373-E381, 2021
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Background. Steroid use for coronavirus disease 2019 (COVID-19) is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. Methods. A parallel, double-blind, placebo-controlled, randomized, Phase Ifb 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. Results. From 18 April to 16 June 2020, 647 patients were screened, 416 were randomized, and 393 were analyzed as mITT, with 194 individuals assigned to MP and 199 to placebo. SARS-CoV-2 infection was confirmed by reverse transcriptase polymerase chain reaction in 81.3%. The mortality rates at Day 28 were not different between groups. A subgroup analysis showed that patients over 60 years old 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. Conclusions. 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.
Palavras-chave
SARS-CoV-2, corticosteroid, inflammation, coronavirus, Brazil
URI
https://observatorio.fm.usp.br/handle/OPI/42123
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MCP
Artigos e Materiais de Revistas Científicas - COVID-19
Artigos e Materiais de Revistas Científicas - HC/ICESP
Artigos e Materiais de Revistas Científicas - HC/InCor
Artigos e Materiais de Revistas Científicas - LIM/08
Artigos e Materiais de Revistas Científicas - ODS/03