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STANDARDIZED BRAZILIAN GREEN PROPOLIS EXTRACT (EPP‑AF®) IN COVID‑19 OUTCOMES: A RANDOMIZED DOUBLE‑BLIND PLACEBO‑CONTROLLED TRIAL
Silveira, Marcelo Augusto Duarte et al. | Date Issued: 2023
Author
Silveira, Marcelo Augusto Duarte
Menezes, Matheus de Alencar
Souza, Sergio Pinto de
Galvão, Erica Batista dos Santos
Berretta, Andresa Aparecida
Caldas, Juliana
Teixeira, Maurício Brito
Gomes, Marcel Miranda Dantas
Damiani, Lucas Petri
Bahiense, Bruno Andrade
Cabral, Julia Barros
Oliveira, Cicero Wandson Luiz Macedo de
Mascarenhas, Talita Rocha
Pinheiro, Priscila Carvalho Guedes
Alves, Milena Souza
Melo, Rodrigo Morel Vieira de
Leite, Flávia Mendes
Nonaka, Carolina Kymie Vasques
Souza, Bruno Solano de Freitas
Baptista, Nathália Ursoli
Teles, Flávio
Guarda, Suzete Farias da
Mendes, Ana Verena Almeida
Passos, Rogério da Hora
Affilliation
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Apis Flora Industrial e Comercial Ltda. Departamento de Desenvolvimento e Inovação. Ribeirão Preto, SP, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital Israelita Albert Einstein. Organização de Pesquisa Acadêmica. São Paulo, SP, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil / Universidade Federal da Bahia. Escola de Medicina. Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Apis Flora Industrial e Comercial Ltda. Departamento de Desenvolvimento e Inovação. Ribeirão Preto, SP, Brasil.
Universidade Federal de Alagoas. Escola de Medicina. Maceió, AL, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil / Universidade Federal da Bahia. Escola de Medicina. Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Hospital São Rafael. Instituto D'Or de Pesquisa e Educação (IDOR). Salvador, BA, Brasil.
Abstract
SARS-CoV-2 and its different variants caused a "wave and wave" pandemic pattern. During the first wave we demonstrated that standardized Brazilian green propolis extract (EPP-AF®) reduces length of hospital stay in adult patients with COVID-19. Afterwards, we decided to evaluate the impact of EPP-AF in hospitalized patients during the third wave of the pandemic. BeeCovid2 was a randomized, double-blind, placebo-controlled clinical trial in hospitalized COVID-19 adult patients. Patients were allocated to receive an oral dose of 900 mg/day of EPP-AF® or placebo for 10 days. The primary outcome was length of hospital stay. Secondary outcomes included safety, secondary infection rate, duration of oxygen therapy dependency, acute kidney injury and need for intensive care. Patients were followed up for 28 days after admission. We enrolled 188 patients; 98 were assigned to the propolis group and 90 to the placebo group. The post-intervention length of hospital stay was of 6.5 ± 6.0 days in the propolis group versus 7.7 ± 7.1 days in the control group (95% CI - 0.74 [- 1.94 to 0.42]; p = 0.22). Propolis did not have significant impact on the need for oxygen supplementation or frequency of AKI. There was a significant difference in the incidence of secondary infection between groups, with 6.1% in the propolis group versus 18.9% in the control group (95% CI - 0.28 [0.1-0.76], p = 0.01). The use of EPP-AF was considered safe and associated with a decrease in secondary infections. The drug was not associated with a significant reduction in length of hospital stay. ClinicalTrials.gov (NCT04800224).
Keywords in Portuguese
Epidemiologia
COVID 19
Coinfecção
Tratamento farmacológico
Método duplo-cego
Própolis
Uso terapêutico
 
Keywords
Epidemiology
COVID-19
Coinfection
Drug Therapy
Double-blind method
Propolis
Therapeutic use
 
DeCS
Epidemiologia
COVID 19
Coinfecção
Tratamento farmacológico
Método duplo-cego
Própole
Uso terapêutico
 
Publisher
Nature Research
Citation
SILVEIRA, Marcelo Augusto Duarte et al. Standardized Brazilian green propolis extract (EPP‑AF®) in COVID‑19 outcomes: a randomized double‑blind placebo‑controlled trial. Scientific Reports, v. 13, n. 1, p. 1-10, 2023.
DOI
10.1038/s41598-023-43764-w
ISSN
2045-2322