Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial

Camila Miriam Suemi Sato Barros, Raissa Soares Freire, Elisângela Frota, Anna Gabriela Rezende Santos, Maria Eduarda Leão Farias, Maria Gabriela Almeida Rodrigues, Bernardo Maia Silva, Christiane Maria Prado Jeronimo, Rebeca Linhares Abreu Netto, Mayla Gabriela Silva Borba, Djane Baía-da-Silva, José Diego Brito-Sousa, Mariana Simão Xavier, Marcia Almeida Araújo-Alexandre, Vanderson Souza Sampaio, Gisely Cardoso Melo, Guilherme Tinoco Arêas, Ludhmila Abrahão Hajjar, Wuelton Marcelo Monteiro, Felipe Gomes Naveca, Fábio Trindade Maranhão Costa, Fernando Fonseca Almeida Val, Marcus Vinícius Guimarães Lacerda, Metcovid team, Adria de Lemos Vasconcelos, Adriana Ferreira Praia Marins, Alexandre de Oliveira Trindade, Aline Sales Mendes Záu, Amanda Carvalho de Oliveira, Ana Carolina Azevedo Furtado, Ana Paula Coelho Rocha, Anderson da Silva Souza, Andiana de Souza Dias, Aníbal Belém, Antonny Michael da Silva Sousa, Beatriz França da Silva, Beatriz Leitão Franco, Bleno Leonam Gonçalves da Costa, Carla C Judice, Carlos Eduardo Padron de Morais, Danielle Severino Sena da Silva, Debora Camila Gomes Duarte, Ejandre Garcia Negreiros da Silva, Elias da Silva Lemos, Elizandra Freitas do Nascimento, Elson Silva de Almeida, Elyana Almeida Marques, Emanuel Medeiros Marinho de Almeida, Emanuelle Lira da Silva, Ester Galvão Dos Santos, Ezequiel da Silva Oliveira, Fábio Manabu Martins Shimizu, Fabíola Ramalho Ferreira de Souza, Felipe da Silva do Vale, Fernanda Dos Santos de Almeida Lima, Fernando Hugo Jesus da Fonseca, Flávia Alencar Fontenelle, Francielen de Azevedo Furtado, Gabrielle Da Silva Pereira, Geísa Aleixo Bezerra, Guilherme Kemeron Maciel Salazar, Handerson da Silva Pereira, Hilda Ferreira de Melo, Ingrid Nascimento Oliveira, Ivanildo Vieira Pereira Filho, Jaily E Silva Rosa, Jacimara Vasques Gomes, Jonas Mota Lemos, Josué Nélio Brutus, Karina Pinheiro Pessoa, Laleyska Deucylane Costa Rodrigues, Larissa Esthefani Barros Cirino, Lauro Fragata Mourão Filho, Leandro Moura, Lorenna Pereira de Souza, Lucas Barbosa Oliveira, Marcela Menezes Dos Santos, Marcus Vinicius Ramos da Silva, Mauro Pereira Rodrigues, Mayara Tavares de Menezes, Micaela Maciel Dos Santos Mota, Nadya Fonseca Corrêa, Najara Bittencourt, Nagila Morais Rocha, Natália Guedes de Melo Silva, Priscilla de Oliveira Saraiva, Quézia de Sousa Monteiro, Rafael Theodoro Dos Santos, Rebecca Augusta de Araújo Pinto, Rodrigo Saboia de Lima Reinan Brotas Ferreira, Rosângela Francisca Tanantas de Melo, Sabrina Teixeira Saenz, Salete Sara Alvarez Fernandes, Sheila Vítor-Silva, Thalie Cavalcante Santos, Tânia Maria Rodrigues de Oliveira, Tatyana A Tavella, Thais Tavares Câmara, Thiago Serrão Pinto, Tilza Waleska Rocha Dos Santos, Valdinete Alves do Nascimento, Wanessa Pessoa Sousa Barbosa, Wellinthon Ferreira de Melo, Wlademir Braga Salgad Sobrinho, Camila Miriam Suemi Sato Barros, Raissa Soares Freire, Elisângela Frota, Anna Gabriela Rezende Santos, Maria Eduarda Leão Farias, Maria Gabriela Almeida Rodrigues, Bernardo Maia Silva, Christiane Maria Prado Jeronimo, Rebeca Linhares Abreu Netto, Mayla Gabriela Silva Borba, Djane Baía-da-Silva, José Diego Brito-Sousa, Mariana Simão Xavier, Marcia Almeida Araújo-Alexandre, Vanderson Souza Sampaio, Gisely Cardoso Melo, Guilherme Tinoco Arêas, Ludhmila Abrahão Hajjar, Wuelton Marcelo Monteiro, Felipe Gomes Naveca, Fábio Trindade Maranhão Costa, Fernando Fonseca Almeida Val, Marcus Vinícius Guimarães Lacerda, Metcovid team, Adria de Lemos Vasconcelos, Adriana Ferreira Praia Marins, Alexandre de Oliveira Trindade, Aline Sales Mendes Záu, Amanda Carvalho de Oliveira, Ana Carolina Azevedo Furtado, Ana Paula Coelho Rocha, Anderson da Silva Souza, Andiana de Souza Dias, Aníbal Belém, Antonny Michael da Silva Sousa, Beatriz França da Silva, Beatriz Leitão Franco, Bleno Leonam Gonçalves da Costa, Carla C Judice, Carlos Eduardo Padron de Morais, Danielle Severino Sena da Silva, Debora Camila Gomes Duarte, Ejandre Garcia Negreiros da Silva, Elias da Silva Lemos, Elizandra Freitas do Nascimento, Elson Silva de Almeida, Elyana Almeida Marques, Emanuel Medeiros Marinho de Almeida, Emanuelle Lira da Silva, Ester Galvão Dos Santos, Ezequiel da Silva Oliveira, Fábio Manabu Martins Shimizu, Fabíola Ramalho Ferreira de Souza, Felipe da Silva do Vale, Fernanda Dos Santos de Almeida Lima, Fernando Hugo Jesus da Fonseca, Flávia Alencar Fontenelle, Francielen de Azevedo Furtado, Gabrielle Da Silva Pereira, Geísa Aleixo Bezerra, Guilherme Kemeron Maciel Salazar, Handerson da Silva Pereira, Hilda Ferreira de Melo, Ingrid Nascimento Oliveira, Ivanildo Vieira Pereira Filho, Jaily E Silva Rosa, Jacimara Vasques Gomes, Jonas Mota Lemos, Josué Nélio Brutus, Karina Pinheiro Pessoa, Laleyska Deucylane Costa Rodrigues, Larissa Esthefani Barros Cirino, Lauro Fragata Mourão Filho, Leandro Moura, Lorenna Pereira de Souza, Lucas Barbosa Oliveira, Marcela Menezes Dos Santos, Marcus Vinicius Ramos da Silva, Mauro Pereira Rodrigues, Mayara Tavares de Menezes, Micaela Maciel Dos Santos Mota, Nadya Fonseca Corrêa, Najara Bittencourt, Nagila Morais Rocha, Natália Guedes de Melo Silva, Priscilla de Oliveira Saraiva, Quézia de Sousa Monteiro, Rafael Theodoro Dos Santos, Rebecca Augusta de Araújo Pinto, Rodrigo Saboia de Lima Reinan Brotas Ferreira, Rosângela Francisca Tanantas de Melo, Sabrina Teixeira Saenz, Salete Sara Alvarez Fernandes, Sheila Vítor-Silva, Thalie Cavalcante Santos, Tânia Maria Rodrigues de Oliveira, Tatyana A Tavella, Thais Tavares Câmara, Thiago Serrão Pinto, Tilza Waleska Rocha Dos Santos, Valdinete Alves do Nascimento, Wanessa Pessoa Sousa Barbosa, Wellinthon Ferreira de Melo, Wlademir Braga Salgad Sobrinho

Abstract

Background: The use of corticosteroids may help control the cytokine storm occurring in acute respiratory failure due to the severe form of COVID-19. We evaluated the postacute effect of corticosteroids used during the acute phase, such as impairment in pulmonary function parameters, on day 120 (D120)-follow-up, in participants who survived over 28 days. Methods: This is a parallel, double-blind, randomized, placebo-controlled phase IIb clinical trial carried out between April 18 and October 9, 2020, conducted in hospitalized patients with clinical-radiological suspicion of COVID-19, aged 18 years or older, with SpO2 ≤ 94% on room air or requiring supplementary oxygen, or under invasive mechanical ventilation (IMV) in a referral center in Manaus, Western Brazilian Amazon. Intravenous methylprednisolone (MP) (0.5 mg/kg) was given two times daily for 5 days to these patients. The primary outcome used for this study was pulmonary function testing at day 120 follow-up visit. Results: Out of the total of surviving patients at day 28 (n = 246) from the Metcovid study, a total of 118 underwent satisfactory pulmonary function testing (62 in the placebo arm and 56 in the MP arm). The supportive treatment was similar between the placebo and MP groups (seven [11%] vs. four [7%]; P = 0.45). At hospital admission, IL-6 levels were higher in the MP group (P < 0.01). Also, the need for ICU (P = 0.06), need for IMV (P = 0.07), and creatine kinase (P = 0.05) on admission also tended to be higher in this group. In the univariate analysis, forced expiratory volume on 1st second of exhalation (FEV1) and forced vital capacity (FVC) at D120 follow-up were significantly higher in patients in the MP arm, being this last parameter also significantly higher in the multivariate analysis independently of IMV and IL-6 levels on admission. Conclusion: The use of steroids for at least 5 days in severe COVID-19 was associated with a higher FVC, which suggests that hospitalized COVID-19 patients might benefit from the use of MP in its use in the long-term, with less pulmonary restrictive functions, attributed to fibrosis. Trial Registration: ClinicalTrials.gov, Identifier: NCT04343729.

Keywords: Brazil; COVID-19; SARS-CoV-2; coronavirus; corticosteroid; inflammation; long-covid; pulmonary function test.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Barros, Freire, Frota, Rezende Santos, Farias, Rodrigues, Silva, Prado Jeronimo, Netto, Silva Borba, Baía-da-Silva, Brito-Sousa, Xavier, Araújo-Alexandre, Sampaio, Melo, Arêas, Hajjar, Monteiro, Gomes Naveca, Costa, Val, Lacerda and the Metcovid team.

Figures

Figure 1
Figure 1
Study flow chart of the Metcovid trial survivors who performed pulmonary function test.

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