tetano
Editor, Senior Moderator
Clin Infect Dis
. 2020 Aug 12;ciaa1177.
doi: 10.1093/cid/ciaa1177. Online ahead of print.
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial
Christiane Maria Prado Jeronimo[SUP] 1 2 [/SUP], Maria Eduarda Le?o Farias[SUP] 1 3 [/SUP], Fernando Fonseca Almeida Val[SUP] 1 2 [/SUP], Vanderson Souza Sampaio[SUP] 1 2 4 [/SUP], Marcia Almeida Ara?jo Alexandre[SUP] 1 [/SUP], Gisely Cardoso Melo[SUP] 1 2 [/SUP], Izabella Picinin Safe[SUP] 1 [/SUP], Mayla Gabriela Silva Borba[SUP] 1 2 [/SUP], Rebeca Linhares Abreu-Netto[SUP] 1 2 [/SUP], Alex Bezerra Silva Maciel[SUP] 1 2 [/SUP], Jo?o Ricardo Silva Neto[SUP] 1 [/SUP], Lucas Barbosa Oliveira[SUP] 1 2 [/SUP], Erick Frota Gomes Figueiredo[SUP] 1 2 [/SUP], Kelry Mazurega Oliveira Dinelly[SUP] 1 2 [/SUP], Maria Gabriela de Almeida Rodrigues[SUP] 1 2 [/SUP], Marcelo Brito[SUP] 1 2 [/SUP], Maria Paula Gomes Mour?o[SUP] 1 2 [/SUP], Guilherme Augusto Pivoto Jo?o[SUP] 1 2 [/SUP], Ludhmila Abrah?o Hajjar[SUP] 5 [/SUP], Quique Bassat[SUP] 6 7 8 9 10 [/SUP], Gustavo Adolfo Sierra Romero[SUP] 11 [/SUP], Felipe Gomes Naveca[SUP] 3 [/SUP], Heline Lira Vasconcelos[SUP] 1 [/SUP], Michel de Ara?jo Tavares[SUP] 12 [/SUP], Jos? Diego Brito-Sousa[SUP] 1 2 [/SUP], Fabio Trindade Maranh?o Costa[SUP] 13 [/SUP], Maur?cio Lacerda Nogueira[SUP] 14 [/SUP], Djane Ba?a-da-Silva[SUP] 1 2 [/SUP], Mariana Sim?o Xavier[SUP] 1 2 15 [/SUP], Wuelton Marcelo Monteiro[SUP] 1 2 [/SUP], Marcus Vin?cius Guimar?es Lacerda[SUP] 1 2 3 [/SUP], , for the Metcovid Team
Affiliations
Abstract
Background: Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19.
Methods: 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. ClinicalTrials Identifier NCT04343729.
Findings: From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years 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.
Conclusion: 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.
Keywords: Brazil; Coronavirus; SARS-CoV-2; corticosteroid; inflammation.
. 2020 Aug 12;ciaa1177.
doi: 10.1093/cid/ciaa1177. Online ahead of print.
Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial
Christiane Maria Prado Jeronimo[SUP] 1 2 [/SUP], Maria Eduarda Le?o Farias[SUP] 1 3 [/SUP], Fernando Fonseca Almeida Val[SUP] 1 2 [/SUP], Vanderson Souza Sampaio[SUP] 1 2 4 [/SUP], Marcia Almeida Ara?jo Alexandre[SUP] 1 [/SUP], Gisely Cardoso Melo[SUP] 1 2 [/SUP], Izabella Picinin Safe[SUP] 1 [/SUP], Mayla Gabriela Silva Borba[SUP] 1 2 [/SUP], Rebeca Linhares Abreu-Netto[SUP] 1 2 [/SUP], Alex Bezerra Silva Maciel[SUP] 1 2 [/SUP], Jo?o Ricardo Silva Neto[SUP] 1 [/SUP], Lucas Barbosa Oliveira[SUP] 1 2 [/SUP], Erick Frota Gomes Figueiredo[SUP] 1 2 [/SUP], Kelry Mazurega Oliveira Dinelly[SUP] 1 2 [/SUP], Maria Gabriela de Almeida Rodrigues[SUP] 1 2 [/SUP], Marcelo Brito[SUP] 1 2 [/SUP], Maria Paula Gomes Mour?o[SUP] 1 2 [/SUP], Guilherme Augusto Pivoto Jo?o[SUP] 1 2 [/SUP], Ludhmila Abrah?o Hajjar[SUP] 5 [/SUP], Quique Bassat[SUP] 6 7 8 9 10 [/SUP], Gustavo Adolfo Sierra Romero[SUP] 11 [/SUP], Felipe Gomes Naveca[SUP] 3 [/SUP], Heline Lira Vasconcelos[SUP] 1 [/SUP], Michel de Ara?jo Tavares[SUP] 12 [/SUP], Jos? Diego Brito-Sousa[SUP] 1 2 [/SUP], Fabio Trindade Maranh?o Costa[SUP] 13 [/SUP], Maur?cio Lacerda Nogueira[SUP] 14 [/SUP], Djane Ba?a-da-Silva[SUP] 1 2 [/SUP], Mariana Sim?o Xavier[SUP] 1 2 15 [/SUP], Wuelton Marcelo Monteiro[SUP] 1 2 [/SUP], Marcus Vin?cius Guimar?es Lacerda[SUP] 1 2 3 [/SUP], , for the Metcovid Team
Affiliations
- PMID: 32785710
- DOI: 10.1093/cid/ciaa1177
Abstract
Background: Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19.
Methods: 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. ClinicalTrials Identifier NCT04343729.
Findings: From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years 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.
Conclusion: 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.
Keywords: Brazil; Coronavirus; SARS-CoV-2; corticosteroid; inflammation.