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

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; Metcovid Team; de Lemos Vasconcelos, Adria; Praia Marins, Adriana Ferreira; de Oliveira Trindade, Alexandre; Mendes Záu, Aline Sales; de Oliveira, Amanda Carvalho; Azevedo Furtado, Ana Carolina; Coelho Rocha, Ana Paula; da Silva Souza, Anderson; de Souza Dias, Andiana; Belém, Aníbal; dos Santos, Anna Gabriela Rezende; da Silva Sousa, Antonny Michael; da Silva, Beatriz França; Franco, Beatriz Leitão; da Silva, Bernardo Maia; da Costa, Bleno Leonam Gonçalves; Sato Barros do Amaral, Camila Miriam Suemi; Judice, Carla C

doi:10.1093/cid/ciaa1177

Cited by 434

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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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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, Metcovid Team, de Lemos Vasconcelos, Adria, Praia Marins, Adriana Ferreira, de Oliveira Trindade, Alexandre, Mendes Záu, Aline Sales, de Oliveira, Amanda Carvalho, Azevedo Furtado, Ana Carolina, Coelho Rocha, Ana Paula, da Silva Souza, Anderson, de Souza Dias, Andiana, Belém, Aníbal, dos Santos, Anna Gabriela Rezende, da Silva Sousa, Antonny Michael, da Silva, Beatriz França, Franco, Beatriz Leitão, da Silva, Bernardo Maia, da Costa, Bleno Leonam Gonçalves, Sato Barros do Amaral, Camila Miriam Suemi, Judice, Carla C, de Morais, Carlos Eduardo Padron, Camilo, Cecília Cunha, Sena da Silva, Danielle Severino, Gomes Duarte, Debora Camila, da Silva, Ejandre Garcia Negreiros, da Silva Lemos, Elias, de Fátima Ponte Frota, Elisângela, do Nascimento, Elizandra Freitas, de Almeida, Elson Silva, Marques, Elyana Almeida, de Almeida, Emanuel Medeiros Marinho, da Silva, Emanuelle Lira, dos Santos, Ester Galvão, da Silva Oliveira, Ezequiel, Martins Shimizu, Fábio Manabu, de Souza, Fabíola Ramalho Ferreira, da Silva do Vale, Felipe, dos Santos de Almeida Lima, Fernanda, da Fonseca, Fernando Hugo Jesus, Fontenelle, Flávia Alencar, de Azevedo Furtado, Francielen, Da Silva Pereira, Gabrielle, Bezerra, Geísa Aleixo, Maciel Salazar, Guilherme Kemeron, da Silva Pereira, Handerson, de Melo, Hilda Ferreira, Oliveira, Ingrid Nascimento, Pereira Filho, Ivanildo Vieira, Gomes, Jacimara Vasques, e Silva Rosa, Jaily, Lemos, Jonas Mota, Brutus, Josué Nélio, Pessoa, Karina Pinheiro, Costa Rodrigues, Laleyska Deucylane, Barros Cirino, Larissa Esthefani, Mourão Filho, Lauro Fragata, Moura, Leandro, Barbosa, Lisiane Rísia Pinto, de Souza, Lorenna Pereira, Oliveira, Lucas Barbosa, de Lima Ferreira, Luiz Carlos, dos Santos, Marcela Menezes, da Silva, Marcus Vinicius Ramos, Rodrigues, Mauro Pereira, de Menezes, Mayara Tavares, dos Santos Mota, Micaela Maciel, Freire, Monique, Corrêa, Nadya Fonseca, Rocha, Nagila Morais, Bittencourt, Najara, de Melo Silva, Natália Guedes, de Oliveira Saraiva, Priscilla, de Sousa Monteiro, Quézia, dos Santos, Rafael Theodoro, Freire, Raíssa Soares, de Araújo Pinto, Rebecca Augusta, Ferreira, Reinan Brotas, de Lima, Rodrigo Saboia, de Melo, Rosângela Francisca Tanantas, Saenz, Sabrina Teixeira, Alvarez Fernandes, Salete Sara, Vítor-Silva, Sheila, de Oliveira, Tânia Maria Rodrigues, Tavella, Tatyana A, Câmara, Thais Tavares, Santos, Thalie Cavalcante, Pinto, Thiago Serrão, dos Santos, Tilza Waleska Rocha, do Nascimento, Valdinete Alves, Sousa Barbosa, Wanessa Pessoa, de Melo, Wellinthon Ferreira, Salgado Sobrinho, Wlademir Braga·2021·Clinical Infectious Diseases

DOI 10.1093/cid/ciaa1177

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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.

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Authors: Jeronimo, C. M. P., Farias, M. E. L., Val, F. F. A., Sampaio, V. S., Alexandre, M. A. A., Melo, G. C., Safe, I. P., Borba, M. G. S., Netto, R. L. A., Maciel, A. B. S., Neto, J. R. S., Oliveira, L. B., Figueiredo, E. F. G., Oliveira Dinelly, K. M., de Almeida Rodrigues, M. G., Brito, M., Mourão, M. P. G., Pivoto João, G. A., Hajjar, L. A., Bassat, Q., Romero, G. A. S., Naveca, F. G., Vasconcelos, H. L., de Araújo Tavares, M., Brito-Sousa, J. D., Costa, F. T. M., Nogueira, M. L., Baía-da-Silva, D. C., Xavier, M. S., Monteiro, W. M., Lacerda, M. V. G., Metcovid Team, de Lemos Vasconcelos, A., Praia Marins, A. F., de Oliveira Trindade, A., Mendes Záu, A. S., de Oliveira, A. C., Azevedo Furtado, A. C., Coelho Rocha, A. P., da Silva Souza, A., de Souza Dias, A., Belém, A., dos Santos, A. G. R., da Silva Sousa, A. M., da Silva, B. F., Franco, B. L., da Silva, B. M., da Costa, B. L. G., Sato Barros do Amaral, C. M. S., Judice, C. C., de Morais, C. E. P., Camilo, C. C., Sena da Silva, D. S., Gomes Duarte, D. C., da Silva, E. G. N., da Silva Lemos, E., de Fátima Ponte Frota, E., do Nascimento, E. F., de Almeida, E. S., Marques, E. A., de Almeida, E. M. M., da Silva, E. L., dos Santos, E. G., da Silva Oliveira, E., Martins Shimizu, F. M., de Souza, F. R. F., da Silva do Vale, F., dos Santos de Almeida Lima, F., da Fonseca, F. H. J., Fontenelle, F. A., de Azevedo Furtado, F., Da Silva Pereira, G., Bezerra, G. A., Maciel Salazar, G. K., da Silva Pereira, H., de Melo, H. F., Oliveira, I. N., Pereira Filho, I. V., Gomes, J. V., e Silva Rosa, J., Lemos, J. M., Brutus, J. N., Pessoa, K. P., Costa Rodrigues, L. D., Barros Cirino, L. E., Mourão Filho, L. F., Moura, L., Barbosa, L. R. P., de Souza, L. P., Oliveira, L. B., de Lima Ferreira, L. C., dos Santos, M. M., da Silva, M. V. R., Rodrigues, M. P., de Menezes, M. T., dos Santos Mota, M. M., Freire, M., Corrêa, N. F., Rocha, N. M., Bittencourt, N., de Melo Silva, N. G., de Oliveira Saraiva, P., de Sousa Monteiro, Q., dos Santos, R. T., Freire, R. S., de Araújo Pinto, R. A., Ferreira, R. B., de Lima, R. S., de Melo, R. F. T., Saenz, S. T., Alvarez Fernandes, S. S., Vítor-Silva, S., de Oliveira, T. M. R., Tavella, T. A., Câmara, T. T., Santos, T. C., Pinto, T. S., dos Santos, T. W. R., do Nascimento, V. A., Sousa Barbosa, W. P., de Melo, W. F., & Salgado Sobrinho, W. B.
Venue: Clinical Infectious Diseases
Publisher: Oxford University Press (OUP)
Published: 2020-08-12
Volume: 72
Issue: 9
Pages: e373-e381
ISSN: 1058-4838 (ISSN-L)
1537-6591
DOI: 10.1093/cid/ciaa1177
OpenAlex: W3048510827
Cited by: 434
References: 37
FWCI: 11.32
Type: journal article
Language: en
Open access: bronze

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This page: CoChat. (2026). Citation check: Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial. https://app.cochat.ai/papers/10.1093/cid/ciaa1177
The paper: Jeronimo, C. M. P., Farias, M. E. L., Val, F. F. A., Sampaio, V. S., Alexandre, M. A. A., Melo, G. C., Safe, I. P., Borba, M. G. S., Netto, R. L. A., Maciel, A. B. S., Neto, J. R. S., Oliveira, L. B., Figueiredo, E. F. G., Oliveira Dinelly, K. M., de Almeida Rodrigues, M. G., Brito, M., Mourão, M. P. G., Pivoto João, G. A., Hajjar, L. A., . . . Salgado Sobrinho, W. B. (2021). Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciaa1177

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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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