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Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial
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 (D12...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8669506/ https://www.ncbi.nlm.nih.gov/pubmed/34917633 http://dx.doi.org/10.3389/fmed.2021.758405 |
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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 |
author_facet | 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 |
author_sort | Barros, Camila Miriam Suemi Sato |
collection | PubMed |
description | 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 SpO(2) ≤ 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. |
format | Online Article Text |
id | pubmed-8669506 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-86695062021-12-15 Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial 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 Front Med (Lausanne) Medicine 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 SpO(2) ≤ 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. Frontiers Media S.A. 2021-11-30 /pmc/articles/PMC8669506/ /pubmed/34917633 http://dx.doi.org/10.3389/fmed.2021.758405 Text en 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. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine 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 Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial |
title | Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial |
title_full | Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial |
title_fullStr | Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial |
title_full_unstemmed | Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial |
title_short | Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial |
title_sort | short-course of methylprednisolone improves respiratory functional parameters after 120 days in hospitalized covid-19 patients (metcovid trial): a randomized clinical trial |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8669506/ https://www.ncbi.nlm.nih.gov/pubmed/34917633 http://dx.doi.org/10.3389/fmed.2021.758405 |
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