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

dc.creatorUrueña, Claudia Patricia
dc.creatorBallesteros Ramírez, Ricardo
dc.creatorGómez Cadena, Alejandra
dc.creatorBarreto, Alfonso
dc.creatorPrieto, Karol
dc.creatorQuijano, Sandra
dc.creatorAschner, Pablo
dc.creatorMartínez, Carlos
dc.creatorEl-Ahanidi, Hajar
dc.creatorJandus, Camilla
dc.creatorZapata Cardona, Maria Isabel
dc.creatorFlórez Álvarez, Lizdany
dc.creatorRugeles López, María Teresa
dc.creatorZapata Builes, Wildeman
dc.creatorGarcía Peña, Angel Alberto
dc.creatorFiorentino, Susana
dc.date2023-06-14T20:46:34Z
dc.date2023-06-14T20:46:34Z
dc.date2022
dc.date.accessioned2024-04-23T14:19:05Z
dc.date.available2024-04-23T14:19:05Z
dc.identifierUrueña C, Ballesteros-Ramírez R, Gomez-Cadena A, Barreto A, Prieto K, Quijano S, Aschner P, Martínez C, Zapata-Cardona MI, El-Ahanidi H, Jandus C, Florez-Alvarez L, Rugeles MT, Zapata-Builes W, Garcia AA, Fiorentino S. Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et). Front Med (Lausanne). 2022 Sep 8;9:991873. doi: 10.3389/fmed.2022.991873. PMID: 36160152; PMCID: PMC9494348.
dc.identifier2296-858X
dc.identifierhttps://hdl.handle.net/10495/35507
dc.identifier10.3389/fmed.2022.991873
dc.identifier2296-858X
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/9229483
dc.descriptionABSTRACT: Background: 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.
dc.descriptionCOL0012444
dc.format22
dc.formatapplication/pdf
dc.formatapplication/pdf
dc.languageeng
dc.publisherFrontiers Media S.A
dc.publisherInmunovirología
dc.publisherLausanne, Suiza
dc.relationFront Med
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rightshttp://creativecommons.org/licenses/by/2.5/co/
dc.rightshttp://purl.org/coar/access_right/c_abf2
dc.rightshttps://creativecommons.org/licenses/by/4.0/
dc.subjectCOVID-19
dc.subjectSARS-CoV-2
dc.subjectMedicina de Hierbas
dc.subjectHerbal Medicine
dc.subjectPlantas Medicinales
dc.subjectPlants, Medicinal
dc.subjectPolifenoles
dc.subjectPolyphenols
dc.subjectInmunomodulación
dc.subjectImmunomodulation
dc.subjectTerapias Complementarias
dc.subjectComplementary Therapies
dc.titleRandomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et)
dc.typeinfo:eu-repo/semantics/article
dc.typeinfo:eu-repo/semantics/publishedVersion
dc.typehttp://purl.org/coar/resource_type/c_2df8fbb1
dc.typehttps://purl.org/redcol/resource_type/ART
dc.typeArtículo de investigación


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