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Randomized Controlled Trial
. 2023 Oct 27;13(1):18405.
doi: 10.1038/s41598-023-43764-w.

Standardized Brazilian green propolis extract (EPP-AF®) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial

Marcelo Augusto Duarte Silveira  1 , Matheus de Alencar Menezes  2 , Sergio Pinto de Souza  2 , Erica Batista Dos Santos Galvão  2 , Andresa Aparecida Berretta  3 , Juliana Caldas  2 , Maurício Brito Teixeira  2 , Marcel Miranda Dantas Gomes  2 , Lucas Petri Damiani  4 , Bruno Andrade Bahiense  2 , Julia Barros Cabral  2 , Cicero Wandson Luiz Macedo De Oliveira  2 , Talita Rocha Mascarenhas  2 , Priscila Carvalho Guedes Pinheiro  2 , Milena Souza Alves  2 , Rodrigo Morel Vieira de Melo  2   5 , Flávia Mendes Leite  2 , Carolina Kymie Vasques Nonaka  2   6 , Bruno Solano de Freitas Souza  2   6 , Nathália Ursoli Baptista  3 , Flávio Teles  7 , Suzete Farias da Guarda  2   5 , Ana Verena Almeida Mendes  2 , Rogério da Hora Passos  2
Affiliations
Randomized Controlled Trial

Standardized Brazilian green propolis extract (EPP-AF®) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial

Marcelo Augusto Duarte Silveira et al. Sci Rep. .

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).

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Consort flow diagram for the BeeCovid2 study.
Figure 2
Figure 2
Cumulative frequencies of COVID-19 patient primary outcomes. The length of hospital stay after randomization for propolis group and placebo group.
See this image and copyright information in PMC

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