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Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et)

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dc.contributor.authorUrueña, Claudia Patricia
dc.contributor.authorBallesteros-Ramírez, Ricardo
dc.contributor.authorGomez-Cadena, Alejandra
dc.contributor.authorBarreto, Alfonso
dc.contributor.authorPrieto, Karol
dc.contributor.authorQuijano, Sandra
dc.contributor.authorAschner, Pablo
dc.contributor.authorMartínez, Carlos
dc.contributor.authorZapata-Cardona, Maria I.
dc.contributor.authorEl-Ahanidi, Hajar
dc.contributor.authorJandus, Camilla
dc.contributor.authorFlorez-Alvarez, Lizdany
dc.contributor.authorRugeles, Maria Teresa
dc.contributor.authorZapata-Builes, Wildeman
dc.contributor.authorGarcia-Pena, A.A.
dc.contributor.authorFiorentino, Susana
dc.contributor.corporatenamePontificia Universidad Javeriana. Facultad de Medicina. Departamento de Medicina Interna. Cardiologíaspa
dc.contributor.javerianateacherGarcia-Pena, A.A.
dc.coverage.spatialColombiaspa
dc.date.accessioned2022-11-16T18:58:24Z
dc.date.available2022-11-16T18:58:24Z
dc.date.created2022-09-08
dc.description.abstractenglishBackground: 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.spa
dc.description.esciNospa
dc.description.indexingRevista Internacional - Indexadaspa
dc.description.orcidhttps://orcid.org/0000-0001-5608-3181spa
dc.description.orcidhttps://orcid.org/0000-0001-5133-2206spa
dc.description.orcidhttps://orcid.org/0000-0001-8491-2952spa
dc.description.orcidhttps://orcid.org/0000-0002-4622-0258spa
dc.description.orcidhttps://orcid.org/0000-0002-3606-2102spa
dc.description.orcidhttps://orcid.org/0000-0002-4664-0682spa
dc.description.publindexA1spa
dc.description.quartilescopusQ1spa
dc.description.quartilewosQ2spa
dc.formatPDFspa
dc.format.mimetypeapplication/pdfspa
dc.identifierhttps://www.frontiersin.org/articles/10.3389/fmed.2022.991873/fullspa
dc.identifier.doihttps://doi.org/10.3389/fmed.2022.991873spa
dc.identifier.instnameinstname:Pontificia Universidad Javerianaspa
dc.identifier.issn2296-858Xspa
dc.identifier.reponamereponame:Repositorio Institucional - Pontificia Universidad Javerianaspa
dc.identifier.repourlrepourl:https://repository.javeriana.edu.cospa
dc.identifier.urihttp://hdl.handle.net/10554/62279
dc.language.isoengspa
dc.relation.citationendpage22spa
dc.relation.citationstartpage1spa
dc.relation.citationvolume9spa
dc.relation.ispartofjournalFrontiers in Medicinespa
dc.rights.coarhttp://purl.org/coar/access_right/c_abf2spa
dc.rights.licenceAtribución-NoComercial 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.subject.keywordCOVID-19spa
dc.subject.keywordPolyphenolsspa
dc.subject.keywordImmunomodulationspa
dc.subject.keywordPhytomedicinespa
dc.subject.keywordComplementary and alternative medicinespa
dc.subject.keywordPolymolecular drugsspa
dc.titleRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et)spa
dc.type.coarhttp://purl.org/coar/resource_type/c_6501spa
dc.type.hasversionhttp://purl.org/coar/version/c_ab4af688f83e57aa
dc.type.localArtículo de revistaspa

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