Randomized double-blind clinical study in patients with COVID-19 to evaluate the safety and efficacy of a phytomedicine (P2Et).
COVID-19
complementary and alternative medicine
immunomodulation
phytomedicine
polymolecular drugs
polyphenols
Journal
Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047
Informations de publication
Date de publication:
2022
2022
Historique:
received:
12
07
2022
accepted:
18
08
2022
entrez:
26
9
2022
pubmed:
27
9
2022
medline:
27
9
2022
Statut:
epublish
Résumé
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 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 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 Taken together these results suggest that P2Et could be consider as a good co-adjuvant in the treatment of COVID-19. https://clinicaltrials.gov/ct2/show/NCT04410510, identifier: NCT04410510.
Sections du résumé
Background
UNASSIGNED
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
Methods
UNASSIGNED
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
Results
UNASSIGNED
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
Conclusions
UNASSIGNED
Taken together these results suggest that P2Et could be consider as a good co-adjuvant in the treatment of COVID-19.
Clinical trail registration
UNASSIGNED
https://clinicaltrials.gov/ct2/show/NCT04410510, identifier: NCT04410510.
Identifiants
pubmed: 36160152
doi: 10.3389/fmed.2022.991873
pmc: PMC9494348
doi:
Banques de données
ClinicalTrials.gov
['NCT04410510']
Types de publication
Journal Article
Langues
eng
Pagination
991873Informations de copyright
Copyright © 2022 Urueña, Ballesteros-Ramírez, Gomez-Cadena, Barreto, Prieto, Quijano, Aschner, Martínez, Zapata-Cardona, El-Ahanidi, Jandus, Florez-Alvarez, Rugeles, Zapata-Builes, Garcia and Fiorentino.
Déclaration de conflit d'intérêts
Authors SF and CU are inventors of a granted patent related to P2Et. Authors SF, CU, and RB-R are partners of the DreemBio company who was a licensee of related patents. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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