Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial

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 Baía-da-Silva, Mariana Simão Xavier, Wuelton Marcelo Monteiro, Marcus Vinícius Guimarães Lacerda
Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America 2020 August 12

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.

Full Text Links

We have located links that may give you full text access.


You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read

Save your favorite articles in one place with a free QxMD account.


Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"