The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial

Trials

Study Protocol

Ana Verena Almeida Mendes¹  Bruno Andrade Bahiense¹  Marcelo Augusto Duarte Silveira¹  Priscila Carvalho Guedes Pinheiro¹  Milena Souza Alves¹  Rogério da Hora Passos¹  Erica Batista dos Santos Galvão¹  Maurício Brito Teixeira¹  Julia Barros Cabral¹  Marcel Miranda Dantas Gomes¹  Cicero Wandson Luiz Macedo De Oliveira¹  Talita Rocha Mascarenhas¹  Sergio Pinto de Souza¹  Flávia Mendes Leite¹  Bruno Solano de Freitas Souza²  Carolina Kymie Vasques Nonaka²  Suzete Farias da Guarda³  Rodrigo Morel Vieira de Melo³  Lucas Petri Damiani⁴  Andresa Aparecida Berretta⁵ 

[1] D’Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, 41253-190, Salvador, BA, Brazil;D’Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, 41253-190, Salvador, BA, Brazil;Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ), 40296-710, Salvador, BA, Brazil;D’Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, 41253-190, Salvador, BA, Brazil;School of Medicine, Federal University of Bahia, Salvador, Bahia, Brazil;HCor Research Institute, São Paulo, Brazil;Research, Development and Innovation Department, Apis Flora Indl. Coml. Ltda, Rua Triunfo 945, Subsetor Sul 3, 14020-670, Ribeirão Preto, SP, Brazil;

关键词: COVID-19;    Randomized controlled trial;    Protocol;    Propolis;    Anti-inflammatory agents;    Immunoregulation;    ACE2;    PAK1 blocker;    TMPRSS2;   

DOI  :  10.1186/s13063-022-06176-1

 received in 2021-06-19, accepted in 2022-03-16,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundThe 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large numbers of people with unprecedented impacts. Experimental evidence has already been obtained for use of the standardized extract of Brazilian green propolis (EPP-AF) against viral targets, and clinical rationality has been demonstrated for testing this extract as an adjunct to treatment in patients affected by COVID-19. The BeeCovid2 study aims to assess whether EPP-AF has an impact on the improvement of patients hospitalized with COVID-19 by reducing the length of hospital stay.MethodsBeeCovid2 is a randomized, double-blinded, placebo-controlled clinical study being conducted in Brazil to provide further evidence on the effectiveness of standardized green propolis extract as an adjunctive treatment for adults hospitalized with COVID-19. Hospitalized patients over 18 years of age with a confirmed diagnosis of COVID-19 and up to 14 days of symptoms were included. Patients under mechanical ventilation at randomization, pregnant women, cancer patients, transplanted or using immunosuppression, HIV patients, patients who used propolis in the last 30 days, bacterial or fungal infection at randomization, impossibility of using medication orally or enterally, and advanced chronic diseases (e.g., advanced heart failure, severe liver disease, and end-stage chronic kidney disease). Enrolled patients are randomized at a 1:1 ratio to receive placebo or standardized propolis extract (900 mg/day) for 10 days. The study treatments are administered in a double-blinded manner, and patients are followed for 28 days. The primary outcome is the difference in length of hospital stay in days between groups. Secondary outcomes include the need for mechanical ventilation, the rate of secondary infection, rate of acute kidney injury, the need for renal replacement therapy, the requirement for vasoactive drugs, the use of an intra-aortic balloon pump (IABP), and the use of extracorporeal membrane oxygenation (ECMO).DiscussionThis trial is very useful and will provide more data on the effectiveness of using the standardized Brazilian green propolis extract as an adjunctive treatment in association with standard care in adults hospitalized with moderate to severe acute COVID-19.Trial registrationClinicalTrials.gov NCT04800224. Registered on March 16, 2021.

【 授权许可】

CC BY   
© The Author(s). 2022

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