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

Abstract

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 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.

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.

CLINICAL TRIALS REGISTRATION:

NCT04343729.

• Authors: Christiane Maria Prado Jeronimo, Maria Eduarda Leão Farias, Fernando Fonseca Almeida Val, Vanderson Souza Sampaio, Marcia Almeida Araújo Alexandre, Gisely Cardoso Melo, Izabella Picinin Safe, Mayla Gabriela Silva Borba, Rebeca Linhares Abreu Netto, Alex Bezerra Silva Maciel, João Ricardo Silva Neto, Lucas Barbosa Oliveira, Erick Frota Gomes Figueiredo, Kelry Mazurega Oliveira Dinelly, Maria Gabriela de Almeida Rodrigues, Marcelo Brito, Maria Paula Gomes Mourão, Guilherme Augusto Pivoto João, Ludhmila Abrahão Hajjar, Quique Bassat, Gustavo Adolfo Sierra Romero, Felipe Gomes Naveca, Heline Lira Vasconcelos, Michel de Araújo Tavares, José Diego Brito-Sousa, Fabio Trindade Maranhão Costa, Maurício Lacerda Nogueira, Djane Clarys Baía-da-Silva, Mariana Simão Xavier, Wuelton Marcelo Monteiro, Marcus Vinícius Guimarães Lacerda, Metcovid Team
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 72 Issue 9 Pg. e373-e381 (05 04 2021) ISSN: 1537-6591 [Electronic] United States
• PMID: 32785710 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

Chemical References

• Methylprednisolone

Topics

• Adolescent
• Adult
• Brazil
• COVID-19
• Double-Blind Method
• Humans
• Methylprednisolone (therapeutic use)
• Middle Aged
• SARS-CoV-2
• Treatment Outcome