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

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Prado Jeronimo, Christiane Maria ^{[1, 2]} ; Leao Farias, Maria Eduarda ^{[3, 2]} ; Almeida Val, Fernando Fonseca ^{[1, 2]} ; Sampaio, Vanderson Souza ^{[1, 4, 2]} ; Araujo Alexandre, Marcia Almeida ^[2] ; Melo, Gisely Cardoso ^{[1, 2]} ; Safe, Izabella Picinin ^[2] ; Silva Borba, Mayla Gabriela ^{[1, 2]} ; Abreu Netto, Rebeca Linhares ^{[1, 2]} ; Silva Maciel, Alex Bezerra ^{[1, 2]} ; Silva Neto, Joao Ricardo ^[2] ; Oliveira, Lucas Barbosa ^{[1, 2]} ; Gomes Figueiredo, Erick Frota ^{[1, 2]} ; Oliveira Dinelly, Kelry Mazurega ^{[1, 2]} ; de Almeida Rodrigues, Maria Gabriela ^{[1, 2]} ; Brito, Marcelo ^{[1, 2]} ; Gomes Mourao, Maria Paula ^{[1, 2]} ; Pivoto Joao, Guilherme Augusto ^{[1, 2]} ; Hajjar, Ludhmila Abrahao ^[5] ; Bassat, Quique ^{[6, 7, 8, 9, 10]} ; Sierra Romero, Gustavo Adolfo ^[11] ; Naveca, Felipe Gomes ^[3] ; Vasconcelos, Heline Lira ^[2] ; Tavares, Michel de Araujo ^[12] ; Brito-Sousa, Jose Diego ^{[1, 2]} ; Maranhao Costa, Fabio Trindade ^[13] ; Nogueira, Mauricio Lacerda ^[14] ; Baia-da-Silva, Djane Clarys ^{[1, 2]} ; Xavier, Mariana Simao ^{[1, 2, 15]} ; Monteiro, Wuelton Marcelo ^{[1, 2]} ; Guimaraes Lacerda, Marcus Vinicius ^{[1, 3, 2]} ; Team, Metcovid

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^[1] Univ Estado Amazonas, Manaus, Amazonas - Brazil

^[2] Fundacao Med Trop Dr Heitor Vieira Dourado, Av Pedro Teixeira 25, BR-69040000 Manaus, Amazonas - Brazil

^[3] FIOCRUZ AMAZONAS, Inst Leonidas & Maria Deane, Manaus, Amazonas - Brazil

^[4] Fundacao Vigilancia Saude Amazonas, Manaus, Amazonas - Brazil

^[5] Univ Sao Paulo, Fac Med, Sao Paulo - Brazil

^[6] Inst Catalana Recerca & Estudis Avancats ICREA, Barcelona - Spain

^[7] Hosp Clin Univ Barcelona, Inst Salud Global Barcelona ISGlobal, Barcelona - Spain

^[8] Ctr Invest Saude Manhica, Maputo - Mozambique

^[9] Univ Barcelona, Pediat Dept, Pediat Infect Dis Unit, Hosp St Joan de Deu, Barcelona - Spain

^[10] Consorcio Invest Biomed Red Epidemiol & Salud Pub, Madrid - Spain

^[11] Univ Brasilia, Nucleo Med Trop, Brasilia, DF - Brazil

^[12] Univ Fed Amazonas, Manaus, Amazonas - Brazil

^[13] Univ Estadual Campinas, Campinas - Brazil

^[14] Fac Med Sao Jose do Rio Preto, Sao Jose Do Rio Preto - Brazil

^[15] Fiocruz MS, Inst Nacl Infectol Carlos Chagas, Rio De Janeiro - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Clinical Infectious Diseases; v. 72, n. 9, p. E373-E381, MAY 1 2021.
• Citações Web of Science: 10

Resumo

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 Ifb 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. (AU)

• Processo FAPESP: 20/05369-6 - Estratégia acelerada por inteligência artificial para reposicionamento de fármacos contra COVID-19
• Beneficiário: Fabio Trindade Maranhão Costa
• Modalidade de apoio: Auxílio à Pesquisa - Regular