Details

Autor(en) / Beteiligte

• 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
• Netto, Rebeca Linhares Abreu
• Maciel, Alex Bezerra Silva
• Neto, João Ricardo Silva
• Oliveira, Lucas Barbosa
• Figueiredo, Erick Frota Gomes
• Oliveira Dinelly, Kelry Mazurega
• de Almeida Rodrigues, Maria Gabriela
• 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
• de Araújo Tavares, Michel
• Brito-Sousa, José Diego
• Costa, Fabio Trindade Maranhão
• Nogueira, Maurício Lacerda
• Baía-da-Silva, Djane Clarys
• Xavier, Mariana Simão
• Monteiro, Wuelton Marcelo
• Lacerda, Marcus Vinícius Guimarães

Titel

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

Ist Teil von

• Clinical infectious diseases, 2021-05, Vol.72 (9), p.e373-e381

Ort / Verlag

United States

Erscheinungsjahr

2021

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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. A 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. 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. 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. NCT04343729.