Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et)
Q2
- Autores:
-
Urueña, Claudia Patricia
Ballesteros-Ramírez, Ricardo
Gomez-Cadena, Alejandra
Barreto, Alfonso
Prieto, Karol
Quijano, Sandra
Aschner, Pablo
Martínez, Carlos
Zapata-Cardona, Maria I.
El-Ahanidi, Hajar
Jandus, Camilla
Florez-Alvarez, Lizdany
Rugeles, Maria Teresa
Zapata-Builes, Wildeman
Garcia-Pena, A.A.
Fiorentino, Susana
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2022
- Institución:
- Pontificia Universidad Javeriana
- Repositorio:
- Repositorio Universidad Javeriana
- Idioma:
- eng
- OAI Identifier:
- oai:repository.javeriana.edu.co:10554/62279
- Acceso en línea:
- https://www.frontiersin.org/articles/10.3389/fmed.2022.991873/full
http://hdl.handle.net/10554/62279
https://doi.org/10.3389/fmed.2022.991873
- Palabra clave:
- COVID-19
Polyphenols
Immunomodulation
Phytomedicine
Complementary and alternative medicine
Polymolecular drugs
- Rights
- License
- Atribución-NoComercial 4.0 Internacional
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| dc.title.spa.fl_str_mv |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| title |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| spellingShingle |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) COVID-19 Polyphenols Immunomodulation Phytomedicine Complementary and alternative medicine Polymolecular drugs |
| title_short |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| title_full |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| title_fullStr |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| title_full_unstemmed |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| title_sort |
Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et) |
| dc.creator.fl_str_mv |
Urueña, Claudia Patricia Ballesteros-Ramírez, Ricardo Gomez-Cadena, Alejandra Barreto, Alfonso Prieto, Karol Quijano, Sandra Aschner, Pablo Martínez, Carlos Zapata-Cardona, Maria I. El-Ahanidi, Hajar Jandus, Camilla Florez-Alvarez, Lizdany Rugeles, Maria Teresa Zapata-Builes, Wildeman Garcia-Pena, A.A. Fiorentino, Susana |
| dc.contributor.author.none.fl_str_mv |
Urueña, Claudia Patricia Ballesteros-Ramírez, Ricardo Gomez-Cadena, Alejandra Barreto, Alfonso Prieto, Karol Quijano, Sandra Aschner, Pablo Martínez, Carlos Zapata-Cardona, Maria I. El-Ahanidi, Hajar Jandus, Camilla Florez-Alvarez, Lizdany Rugeles, Maria Teresa Zapata-Builes, Wildeman Garcia-Pena, A.A. Fiorentino, Susana |
| dc.contributor.corporatename.spa.fl_str_mv |
Pontificia Universidad Javeriana. Facultad de Medicina. Departamento de Medicina Interna. Cardiología |
| dc.contributor.javerianateacher.none.fl_str_mv |
Garcia-Pena, A.A. |
| dc.subject.keyword.spa.fl_str_mv |
COVID-19 Polyphenols Immunomodulation Phytomedicine Complementary and alternative medicine Polymolecular drugs |
| topic |
COVID-19 Polyphenols Immunomodulation Phytomedicine Complementary and alternative medicine Polymolecular drugs |
| description |
Q2 |
| publishDate |
2022 |
| dc.date.accessioned.none.fl_str_mv |
2022-11-16T18:58:24Z |
| dc.date.available.none.fl_str_mv |
2022-11-16T18:58:24Z |
| dc.date.created.none.fl_str_mv |
2022-09-08 |
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Artículo de revista |
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http://purl.org/coar/resource_type/c_6501 |
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http://purl.org/coar/resource_type/c_6501 |
| dc.identifier.spa.fl_str_mv |
https://www.frontiersin.org/articles/10.3389/fmed.2022.991873/full |
| dc.identifier.issn.spa.fl_str_mv |
2296-858X |
| dc.identifier.uri.none.fl_str_mv |
http://hdl.handle.net/10554/62279 |
| dc.identifier.doi.spa.fl_str_mv |
https://doi.org/10.3389/fmed.2022.991873 |
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instname:Pontificia Universidad Javeriana |
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https://www.frontiersin.org/articles/10.3389/fmed.2022.991873/full http://hdl.handle.net/10554/62279 https://doi.org/10.3389/fmed.2022.991873 |
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2296-858X instname:Pontificia Universidad Javeriana reponame:Repositorio Institucional - Pontificia Universidad Javeriana repourl:https://repository.javeriana.edu.co |
| dc.language.iso.spa.fl_str_mv |
eng |
| language |
eng |
| dc.relation.citationstartpage.spa.fl_str_mv |
1 |
| dc.relation.citationendpage.spa.fl_str_mv |
22 |
| dc.relation.ispartofjournal.spa.fl_str_mv |
Frontiers in Medicine |
| dc.relation.citationvolume.spa.fl_str_mv |
9 |
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Atribución-NoComercial 4.0 Internacional |
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http://creativecommons.org/licenses/by-nc/4.0/ |
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Colombia |
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Atribución-NoComercial 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc/4.0/http://purl.org/coar/access_right/c_abf2Urueña, Claudia PatriciaBallesteros-Ramírez, RicardoGomez-Cadena, AlejandraBarreto, AlfonsoPrieto, KarolQuijano, SandraAschner, PabloMartínez, CarlosZapata-Cardona, Maria I.El-Ahanidi, HajarJandus, CamillaFlorez-Alvarez, LizdanyRugeles, Maria TeresaZapata-Builes, WildemanGarcia-Pena, A.A.Fiorentino, SusanaPontificia Universidad Javeriana. Facultad de Medicina. Departamento de Medicina Interna. CardiologíaGarcia-Pena, A.A.Colombia2022-11-16T18:58:24Z2022-11-16T18:58:24Z2022-09-08https://www.frontiersin.org/articles/10.3389/fmed.2022.991873/full2296-858Xhttp://hdl.handle.net/10554/62279https://doi.org/10.3389/fmed.2022.991873instname:Pontificia Universidad Javerianareponame:Repositorio Institucional - Pontificia Universidad Javerianarepourl:https://repository.javeriana.edu.coPDFapplication/pdfengRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et)Artículo de revistahttp://purl.org/coar/resource_type/c_6501Q2Q1Background: It has been proposed that polyphenols can be used in the development of new therapies against COVID-19, given their ability to interfere with the adsorption and entrance processes of the virus, thus disrupting viral replication. Seeds from Caesalpinia spinosa, have been traditionally used for the treatment of inflammatory pathologies and respiratory diseases. Our team has obtained an extract called P2Et, rich in polyphenols derived from gallic acid with significant antioxidant activity, and the ability to induce complete autophagy in tumor cells and reduce the systemic inflammatory response in animal models. Methods: In this work, a phase II multicenter randomized double-blind clinical trial on COVID-19 patients was designed to evaluate the impact of the P2Et treatment on the clinical outcome and the immunological parameters related to the evolution of the disease. The Trial was registered with the number No. NCT04410510∗. A complementary study in an animal model of lung fibrosis was carried out to evaluate in situ lung changes after P2Et in vivo administration. The ability of P2Et to inhibit the viral load of murine and human coronaviruses in cellular models was also evaluated. Results: Patients treated with P2Et were discharged on average after 7.4 days of admission vs. 9.6 days in the placebo group. Although a decrease in proinflammatory cytokines such as G-CSF, IL-15, IL-12, IL-6, IP10, MCP-1, MCP-2 and IL-18 was observed in both groups, P2Et decreased to a greater extent G-CSF, IL-6 and IL-18 among others, which are related to lower recovery of patients in the long term. The frequency of T lymphocytes (LT) CD3+, LT double negative (CD3+CD4-CD8-), NK cells increased in the P2Et group where the population of eosinophils was also significantly reduced. In the murine bleomycin model, P2Et also reduced lung inflammation and fibrosis. P2Et was able to reduce the viral replication of murine and human coronaviruses in vitro, showing its dual antiviral and anti-inflammatory role, key in disease control. Conclusions: Taken together these results suggest that P2Et could be consider as a good co-adjuvant in the treatment of COVID-19.https://orcid.org/0000-0001-5608-3181https://orcid.org/0000-0001-5133-2206https://orcid.org/0000-0001-8491-2952https://orcid.org/0000-0002-4622-0258https://orcid.org/0000-0002-3606-2102https://orcid.org/0000-0002-4664-0682Revista Internacional - IndexadaA1NoCOVID-19PolyphenolsImmunomodulationPhytomedicineComplementary and alternative medicinePolymolecular drugs122Frontiers in Medicine9ORIGINALRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et).pdfRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et).pdfArtículoapplication/pdf3039473http://repository.javeriana.edu.co/bitstream/10554/62279/1/Randomized%20double-blind%20clinical%20study%20in%20patients%20with%20COVID-19%20to%20evaluate%20the%20safety%20and%20efficacy%20of%20a%20phytomedicine%20%28P2Et%29.pdf0f5db162155945648d3c9584c5a00ee8MD51embargoed access|||2222-11-11LICENSElicense.txtlicense.txttext/plain; charset=utf-82603http://repository.javeriana.edu.co/bitstream/10554/62279/2/license.txt2070d280cc89439d983d9eee1b17df53MD52open accessTHUMBNAILRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et).pdf.jpgRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et).pdf.jpgIM Thumbnailimage/jpeg7964http://repository.javeriana.edu.co/bitstream/10554/62279/3/Randomized%20double-blind%20clinical%20study%20in%20patients%20with%20COVID-19%20to%20evaluate%20the%20safety%20and%20efficacy%20of%20a%20phytomedicine%20%28P2Et%29.pdf.jpg6bc6655072c4bf19a6da847231a376ddMD53open access10554/62279oai:repository.javeriana.edu.co:10554/622792022-12-09 09:26:57.93Repositorio Institucional - Pontificia Universidad Javerianarepositorio@javeriana.edu.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 |