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
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/52597 |
Resumo: | D'Or Institute for Education and Research. A Fundação Maria Emília Pedreira Freire de Carvalho (FME). |
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Silveira, Marcelo Augusto DuarteSouza, Sergio Pinto deGalvão, Erica Batista dos SantosTeixeira, Maurício BritoGomes, Marcel Miranda DantasDamiani, Lucas PetriBahiense, Bruno AndradeCabral, Julia BarrosOliveira, Cicero Wandson Luiz Macedo deMascarenhas, Talita RochaPinheiro, Priscila Carvalho GuedesAlves, Milena SouzaMelo, Rodrigo Morel Vieira deBerretta, Andresa AparecidaLeite, Flávia MendesNonaka, Carolina Kymie VasquesSouza, Bruno Solano de FreitasMendes, Ana Verena AlmeidaGuarda, Suzete Farias daPassos, Rogério da Hora2022-05-10T11:57:21Z2022-05-10T11:57:21Z2022SILVEIRA, Marcelo Augusto Duarte et al. 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, n. 255, p. 1-7, 2022.1745-6215https://www.arca.fiocruz.br/handle/icict/5259710.1186/s13063-022-06176-1D'Or Institute for Education and Research. A Fundação Maria Emília Pedreira Freire de Carvalho (FME).D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.Instituto de Pesquisa HCor. São Paulo, SP, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil / Universidade Federal da Bahia. Escola de Medicina. Salvador, BA, Brasil.Departamento de Pesquisa, Desenvolvimento e Inovação, Apis Flora Indl. Com. Ltda. Ribeirão Preto, SP, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilD'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil / Universidade Federal da Bahia. Escola de Medicina. Salvador, BA, Brasil.D'Or Instituto de Pesquisa e Educação. Hospital São Rafael. Salvador, BA, Brasil.Background: The 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. Methods: BeeCovid2 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). Discussion: This 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.engBMCCOVID-19Randomized Controlled TrialPropolisAnti-Inflammatory AgentsCOVID-19Teste controlado e aleatórioProtocoloPrópolisAgentes anti-inflamatóriosImunoregulaçãoACE2bloqueador PAK1TMPRSS2COVID-19Randomized controlled trialProtocolPropolisAnti-inflammatory agentsImmunoregulationACE2PAK1 blockerTMPRSS2bloqueador PAK1COVID-19Ensayo controlado aleatorizadoProtocoloPropóleosAgentes antiinflamatoriosinmunorregulaciónACE2bloqueador PAKTMPRSS2COVID-19Essai contrôlé randomiséProtocolePropolisAgents anti-inflammatoiresImmunorégulationACE2Bloqueur PAK1TMPRSS2COVID-19Ensaio Clínico Controlado AleatórioProtocolo de Ensaio ClínicoPrópoleAnti-InflamatóriosEnzima de Conversão de Angiotensina 2The 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 trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/52597/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALSilveira, M. A. D. - The use of standardized.pdfSilveira, M. A. 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dc.title.pt_BR.fl_str_mv |
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 |
title |
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 |
spellingShingle |
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 Silveira, Marcelo Augusto Duarte COVID-19 Randomized Controlled Trial Propolis Anti-Inflammatory Agents COVID-19 Teste controlado e aleatório Protocolo Própolis Agentes anti-inflamatórios Imunoregulação ACE2 bloqueador PAK1 TMPRSS2 COVID-19 Randomized controlled trial Protocol Propolis Anti-inflammatory agents Immunoregulation ACE2 PAK1 blocker TMPRSS2 bloqueador PAK1 COVID-19 Ensayo controlado aleatorizado Protocolo Propóleos Agentes antiinflamatorios inmunorregulación ACE2 bloqueador PAK TMPRSS2 COVID-19 Essai contrôlé randomisé Protocole Propolis Agents anti-inflammatoires Immunorégulation ACE2 Bloqueur PAK1 TMPRSS2 COVID-19 Ensaio Clínico Controlado Aleatório Protocolo de Ensaio Clínico Própole Anti-Inflamatórios Enzima de Conversão de Angiotensina 2 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
author |
Silveira, Marcelo Augusto Duarte |
author_facet |
Silveira, Marcelo Augusto Duarte Souza, Sergio Pinto de Galvão, Erica Batista dos Santos 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 Berretta, Andresa Aparecida Leite, Flávia Mendes Nonaka, Carolina Kymie Vasques Souza, Bruno Solano de Freitas Mendes, Ana Verena Almeida Guarda, Suzete Farias da Passos, Rogério da Hora |
author_role |
author |
author2 |
Souza, Sergio Pinto de Galvão, Erica Batista dos Santos 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 Berretta, Andresa Aparecida Leite, Flávia Mendes Nonaka, Carolina Kymie Vasques Souza, Bruno Solano de Freitas Mendes, Ana Verena Almeida Guarda, Suzete Farias da Passos, Rogério da Hora |
author2_role |
author author author author author author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Silveira, Marcelo Augusto Duarte Souza, Sergio Pinto de Galvão, Erica Batista dos Santos 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 Berretta, Andresa Aparecida Leite, Flávia Mendes Nonaka, Carolina Kymie Vasques Souza, Bruno Solano de Freitas Mendes, Ana Verena Almeida Guarda, Suzete Farias da Passos, Rogério da Hora |
dc.subject.mesh.pt_BR.fl_str_mv |
COVID-19 Randomized Controlled Trial Propolis Anti-Inflammatory Agents |
topic |
COVID-19 Randomized Controlled Trial Propolis Anti-Inflammatory Agents COVID-19 Teste controlado e aleatório Protocolo Própolis Agentes anti-inflamatórios Imunoregulação ACE2 bloqueador PAK1 TMPRSS2 COVID-19 Randomized controlled trial Protocol Propolis Anti-inflammatory agents Immunoregulation ACE2 PAK1 blocker TMPRSS2 bloqueador PAK1 COVID-19 Ensayo controlado aleatorizado Protocolo Propóleos Agentes antiinflamatorios inmunorregulación ACE2 bloqueador PAK TMPRSS2 COVID-19 Essai contrôlé randomisé Protocole Propolis Agents anti-inflammatoires Immunorégulation ACE2 Bloqueur PAK1 TMPRSS2 COVID-19 Ensaio Clínico Controlado Aleatório Protocolo de Ensaio Clínico Própole Anti-Inflamatórios Enzima de Conversão de Angiotensina 2 |
dc.subject.other.pt_BR.fl_str_mv |
COVID-19 Teste controlado e aleatório Protocolo Própolis Agentes anti-inflamatórios Imunoregulação ACE2 bloqueador PAK1 TMPRSS2 |
dc.subject.en.pt_BR.fl_str_mv |
COVID-19 Randomized controlled trial Protocol Propolis Anti-inflammatory agents Immunoregulation ACE2 PAK1 blocker TMPRSS2 bloqueador PAK1 |
dc.subject.es.pt_BR.fl_str_mv |
COVID-19 Ensayo controlado aleatorizado Protocolo Propóleos Agentes antiinflamatorios inmunorregulación ACE2 bloqueador PAK TMPRSS2 |
dc.subject.fr.pt_BR.fl_str_mv |
COVID-19 Essai contrôlé randomisé Protocole Propolis Agents anti-inflammatoires Immunorégulation ACE2 Bloqueur PAK1 TMPRSS2 |
dc.subject.decs.pt_BR.fl_str_mv |
COVID-19 Ensaio Clínico Controlado Aleatório Protocolo de Ensaio Clínico Própole Anti-Inflamatórios Enzima de Conversão de Angiotensina 2 |
description |
D'Or Institute for Education and Research. A Fundação Maria Emília Pedreira Freire de Carvalho (FME). |
publishDate |
2022 |
dc.date.accessioned.fl_str_mv |
2022-05-10T11:57:21Z |
dc.date.available.fl_str_mv |
2022-05-10T11:57:21Z |
dc.date.issued.fl_str_mv |
2022 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
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article |
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publishedVersion |
dc.identifier.citation.fl_str_mv |
SILVEIRA, Marcelo Augusto Duarte et al. 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, n. 255, p. 1-7, 2022. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/52597 |
dc.identifier.issn.pt_BR.fl_str_mv |
1745-6215 |
dc.identifier.doi.none.fl_str_mv |
10.1186/s13063-022-06176-1 |
identifier_str_mv |
SILVEIRA, Marcelo Augusto Duarte et al. 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, n. 255, p. 1-7, 2022. 1745-6215 10.1186/s13063-022-06176-1 |
url |
https://www.arca.fiocruz.br/handle/icict/52597 |
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eng |
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