期刊
CLINICAL INFECTIOUS DISEASES
卷 72, 期 9, 页码 E373-E381出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1177
关键词
SARS-CoV-2; corticosteroid; inflammation; coronavirus; Brazil
资金
- Superintendencia da Zona Franca de Manaus
- Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES)
- Departamento de Ciencia e Tecnologia/Ministerio da Saude
- Ministerio da Ciencia, Tecnologia e Inovacoes
- Conselho Nacional de Desenvolvimento Cientifico e Tecnologico [403253/2020-9]
- Fundacao de Amparo a Pesquisa do Estado do Amazonas (FAPEAM) [PAPAC 005/2019]
- Fundacao de Amparo a Pesquisa do Estado de Sao Paulo [2020/05369-6]
- FAPEAM
- CAPES
- Spanish Ministry of Science and Innovation through the Centro de Excelencia Severo Ochoa 2019-2023 Program [CEX2018-000806-S]
- Generalitat de Catalunya through the Centres de Recerca de Catalunya (CERCA) Program
- Government of Mozambique
- Spanish Agency for International Development (AECID)
This study evaluated the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19 and found that a short course of MP did not reduce mortality in the overall population. However, patients over 60 years old in the MP group had a lower mortality rate, suggesting potential benefits for this age group.
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.
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