NCT04410510

P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19

Study of the P2Et Extract Obtained From Caesalpinia Spinosa in the Symptomatic Treatment of Subjects With COVID-19 at the Hospital Universitario San Ignacio, Colombia.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital Universitario San Ignacio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.

Detailed description

Phytomedicines have been used in multiple pathologies such as cancer, diabetes, HIV and respiratory pathologies, in which the inflammatory component is characterized. The extracts of these phytomedicines have a high antioxidant capacity related to the fact that their constituents are compounds of the polyphenol type, and this antioxidant mechanism has been related in part to the antiviral action they present. Particularly, in respiratory pathologies such as SARS-CoV, MERS-CoV, and Covid-19, an important inflammatory component is observed. Patients infected with COVID-19 have high amounts of IL1-, IFN-γ, IP-10, and MCP-1, which are likely to trigger the Th1 cellular response. Furthermore, patients requiring ICU admission have higher concentrations of G-CSF, IP-10, MCP-1, MIP1-, and TNF-α, suggesting that cytokine storm is associated with the severity of the clinical picture. Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load. The primary outcome is to evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19

Conditions

• COVID
• Coronavirus Infection
• SARS-CoV 2
• COVID19

Interventions

Type	Name	Description
DRUG	P2Et (Caesalpinia spinosa extract)	P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care
OTHER	Placebo	Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-06-30
• Completion: 2021-11-30
• First posted: 2020-06-01
• Last updated: 2021-08-10

Locations

1 site across 1 country: Colombia