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Efficacy of propolis as an adjunct treatment for hospitalized COVID-19 patients: a randomized, controlled clinical trial Marcelo Augusto Duarte Silveira 1 *, David De Jong 2 , Erica Batista dos Santos Galvao 1 , Juliana Caldas Ribeiro 1 ' 2 ' 3 , Thiago Cer eira Silva 5 ' 6 , Anesa Aparecida Berretta 7 , Thais Chaves Amorim 1 , Raissa Lanna Araujo San Martin 1 , Luis Filipe Miranda Rebelo da Concei9ao 1 , Marcel Miranda Dantas Gomes 1 , Mauricio Brito Teixeira 1 ' 4 ' 8 , Sergio Pinto de Souza 1 ' 4 , Marcele Helena Celestino Alves dos Santos 1 , Marcio de Oliveira Silva 1 , Moni e Lirio 1 , Lis Moreno 1 , Julio Cezar Miranda Saaio 1 , Renata Mendon9a 1 , Silviana Salles Ultchak 1 , Fabio Santos Amorim 1 , Joao Gabriel Rosa 1 , Paulo Benigno Pena Batista 1 , Suzete Nascimento Farias da Guarda 1 ' 6 , Ana Verena Almeida Mendes 1 Rogerio da Hora Passos 1 , r the BeeCovid Team. 1 D'Or Institute r Research and Education (IDOR), Hospital Sao Rael, Salvador, Bahia, Brazil. email: marceloadsilveira@ail.com 2 Genetics Department, Ribeirao Preto School of Medicine, University of Sao Pꜷlo (USP), Ribeirao Preto, Sao Paulo, Brazil. 3 Universidade de Salvador- IFACS, Salvador, Bahia, Brazil. 4 Escola Bahiana de Medicina e Saude Publica- EBMSP, Salvador, Bahia, Brazil. 5 Instituto Gorn;alo Moniz, Funda9ao Oswaldo Cruz (FIOCRUZ), Salvador, Bahia, Brazil. 6 School of Medicine, Federal University of Bahia, Salvador, Bahia, Brazil. 7 Research, Development and Innovation Department, Apis Flora Indl. Coml. Ltda, Ribeirao Preto, Sao Paulo, Brazil. 8 Universidade do Estado da Bahia (EB), Salvador, Bahia, Brazil. *Corresponding Author: Marcelo Augusto Duarte Silveira, MD, PhD, D'Or Institute r Research and Education (IDOR), Hospital Sao Rael, Sao Rael Avenue, 2152 - Sao Marcos, Salvador - Bahia, 41253-190, Brazil ([email protected]). Phone number+ 55 71 3281-6543 I +55 11 98775-6175. Among candidate treatment options r COVID-19, propolis, produced by honey bees om bioactive plant exudates, has shown potential against viral targets and has demonstrated immunoregulatory properties. We conducted a randomized, controlled, open-label, single center trial, with a standardized propolis product (EPP-AF) on hospitalized adult COVID-19 patients. Patients received standard care plus propolis at an oral dose of 400mg/day (n = 40) or 800mg/day (n = 42) r seven days, or standard care alone (n = 42). Standard care included all necessary interventions, as determined by the attending physician. The primary end point was the time to clinical improvement defined as the length of hospital stay or oxygen therapy dependency. Secondary outcomes included acute kidney injury and need r intensive care or vasoactive drugs. Time in the hospital aſter intervention was significantly shortened in . CC-BY-NC-ND 4.0 International license It is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted January 9, 2021. ; https://doi.org/10.1101/2021.01.08.20248932 doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.

Efficacy of propolis as an adjunct treatment for hospitalized … · 2021. 1. 8. · Concei9ao1, Marcel Miranda Dantas Gomes1, Mauricio Brito Teixeira1'4'8, Sergio Pinto de Souza

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  • Efficacy of propolis as an adjunct treatment for hospitalized COVID-19

    patients: a randomized, controlled clinical trial

    Marcelo Augusto Duarte Silveira1*, David De Jong2, Erica Batista dos Santos Galvao1, Juliana Caldas Ribeiro 1'2'3, Thiago Cerqueira Silva

    5'6, Andresa Aparecida Berretta 7, Thais

    Chaves Amorim1 , Raissa Lanna Araujo San Martin1 , Luis Filipe Miranda Rebelo da Concei9ao1, Marcel Miranda Dantas Gomes1, Mauricio Brito Teixeira1'4'8, Sergio Pinto de Souza 1 '4, Marcele Helena Celestino Alves dos Santos 1 , Marcio de Oliveira Silva 1 , Monique Lirio1, Lis Moreno 1 , Julio Cezar Miranda Sampaio1 , Renata Mendon9a 1 , Silviana Salles Ultchak1 , Fabio Santos Amorim1 , Joao Gabriel Rosa1 , Paulo Benigno Pena Batista1 , Suzete Nascimento Farias da Guarda1 '6, Ana Verena Almeida Mendes1 Rogerio da Hora Passos1 ,for the BeeCovid Team.

    1D'Or Institute for Research and Education (IDOR), Hospital Sao Rafael, Salvador, Bahia, Brazil.email: [email protected] 2Genetics Department, Ribeirao Preto School of Medicine, University of Sao Paulo (USP), Ribeirao Preto, Sao Paulo, Brazil. 3Universidade de Salvador- UNIF ACS, Salvador, Bahia, Brazil. 4Escola Bahiana de Medicina e Saude Publica- EBMSP, Salvador, Bahia, Brazil. 5Instituto Gorn;alo Moniz, Funda9ao Oswaldo Cruz (FIOCRUZ), Salvador, Bahia, Brazil. 6School of Medicine, Federal University of Bahia, Salvador, Bahia, Brazil. 7Research, Development and Innovation Department, Apis Flora Indl. Coml. Ltda, Ribeirao Preto, Sao Paulo, Brazil. 8Universidade do Estado da Bahia (UNEB), Salvador, Bahia, Brazil.

    *Corresponding Author: Marcelo Augusto Duarte Silveira, MD, PhD, D'Or Institute for Researchand Education (IDOR), Hospital Sao Rafael, Sao Rafael Avenue, 2152 - Sao Marcos, Salvador -Bahia, 41253-190, Brazil ([email protected]). Phone number+ 55 71 3281-6543 I +5511 98775-6175.

    Among candidate treatment options for COVID-19, propolis, produced by honey bees

    from bioactive plant exudates, has shown potential against viral targets and has

    demonstrated immunoregulatory properties. We conducted a randomized, controlled,

    open-label, single center trial, with a standardized propolis product (EPP-AF) on

    hospitalized adult COVID-19 patients. Patients received standard care plus propolis

    at an oral dose of 400mg/day (n=40) or 800mg/day (n=42) for seven days, or standard

    care alone (n=42). Standard care included all necessary interventions, as determined

    by the attending physician. The primary end point was the time to clinical

    improvement defined as the length of hospital stay or oxygen therapy dependency.

    Secondary outcomes included acute kidney injury and need for intensive care or

    vasoactive drugs. Time in the hospital after intervention was significantly shortened in

    . CC-BY-NC-ND 4.0 International licenseIt is made available under a perpetuity.

    is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 9, 2021. ; https://doi.org/10.1101/2021.01.08.20248932doi: medRxiv preprint

    NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.

    https://doi.org/10.1101/2021.01.08.20248932http://creativecommons.org/licenses/by-nc-nd/4.0/

  • . CC-BY-NC-ND 4.0 International licenseIt is made available under a perpetuity.

    is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 9, 2021. ; https://doi.org/10.1101/2021.01.08.20248932doi: medRxiv preprint

    https://doi.org/10.1101/2021.01.08.20248932http://creativecommons.org/licenses/by-nc-nd/4.0/

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    is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 9, 2021. ; https://doi.org/10.1101/2021.01.08.20248932doi: medRxiv preprint

    https://doi.org/10.1101/2021.01.08.20248932http://creativecommons.org/licenses/by-nc-nd/4.0/

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