AUTHOR=Barros Camila Miriam Suemi Sato , Freire Raissa Soares , Frota Elisângela , Rezende Santos Anna Gabriela , Farias Maria Eduarda Leão , Rodrigues Maria Gabriela Almeida , Silva Bernardo Maia , Prado Jeronimo Christiane Maria , Netto Rebeca Linhares Abreu , Silva Borba Mayla Gabriela , Baía-da-Silva Djane , Brito-Sousa José Diego , Xavier Mariana Simão , Araújo-Alexandre Marcia Almeida , Sampaio Vanderson Souza , Melo Gisely Cardoso , Arêas Guilherme Tinoco , Hajjar Ludhmila Abrahão , Monteiro Wuelton Marcelo , Gomes Naveca Felipe , Costa Fábio Trindade Maranhão , Val Fernando Fonseca Almeida , Lacerda Marcus Vinícius Guimarães , The 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 , da Silva Sousa Antonny Michael , da Silva Beatriz França , Leitão Franco Beatriz , da Costa Bleno Leonam Gonçalves , Judice Carla C. , de Morais Carlos Eduardo Padron , da Silva Danielle Severino Sena , Gomes Duarte Debora Camila , da Silva Ejandre Garcia Negreiros , da Silva Lemos Elias , 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 , Salazar Guilherme Kemeron Maciel , da Silva Pereira Handerson , de Melo Hilda Ferreira , Oliveira Ingrid Nascimento , Pereira Filho Ivanildo Vieira , Rosa Jaily e Silva , Gomes Jacimara Vasques , Lemos Jonas Mota , Brutus Josué Nélio , Pessoa Karina Pinheiro , Costa Rodrigues Laleyska Deucylane , Barros Cirino Larissa Esthefani , Mourão Filho Lauro Fragata , Moura Leandro , de Souza Lorenna Pereira , Oliveira Lucas Barbosa , dos Santos Marcela Menezes , da Silva Marcus Vinicius Ramos , Rodrigues Mauro Pereira , de Menezes Mayara Tavares , dos Santos Mota Micaela Maciel , Corrêa Nadya Fonseca , Bittencourt Najara , Rocha Nagila Morais , de Melo Silva Natália Guedes , de Oliveira Saraiva Priscilla , de Sousa Monteiro Quézia , dos Santos Rafael Theodoro , de Araújo Pinto Rebecca Augusta , de Lima Reinan Brotas Ferreira Rodrigo Saboia , de Melo Rosângela Francisca Tanantas , Saenz Sabrina Teixeira , Alvarez Fernandes Salete Sara , Vítor-Silva Sheila , Santos Thalie Cavalcante , de Oliveira Tânia Maria Rodrigues , Tavella Tatyana A. , Câmara Thais Tavares , Pinto Thiago Serrão , dos Santos Tilza Waleska Rocha , do Nascimento Valdinete Alves , Sousa Barbosa Wanessa Pessoa , de Melo Wellinthon Ferreira , Salgad Sobrinho Wlademir Braga
TITLE=Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial
JOURNAL=Frontiers in Medicine
VOLUME=8
YEAR=2021
URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.758405
DOI=10.3389/fmed.2021.758405
ISSN=2296-858X
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.