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

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario San Ignacio
• Collaborator: Pontificia Universidad Javeriana

Criteria

Inclusion Criteria:

• Adults over 18 years old.

• Diagnosis (suspected or confirmed) of COVID-19 infection, with In-hospital management indication according to the Colombian Consensus of care, diagnosis and management of SARS-COV-2 / COVID-19 infection in health care establishments (Trujillo, 2020). Recommendations based on expert consensus and informed by evidence and the recommendations of the Ministry of Health and Social Protection for April 2020.

All patients who enter the HUSI with a clinical diagnosis of COVID-19 are eligible to enter the study if they present at least one of the following indicators of respiratory compromise:

• Hypoxemia with supplemental oxygen requirements.

• Severe pneumonia: Suspicion of respiratory infection, failure of 1 organ,

• SaO2 ambient air <90% or respiratory rate> 30 resp / min.

• ARDS Acute Respiratory Distress Syndrome. Clinical findings, radiographic bilateral infiltrates + oxygenation deficit: Mild: 200 mmHg100 mmHg SaO2 / FiO2.

• Sepsis: Defined as organic dysfunction and can be identified as an acute change in the SOFA scale> 2 points. Quick SOFA (qSOFA) with 2 of the following 3 clinical variables can identify seriously ill patients: Glasgow 13 or lower, a systolic pressure of 100 mmHg or lower and respiratory rate of 22 / min or higher. Organic insufficiency can manifest with the following alterations: Acute confusional state, Respiratory insufficiency, Reduction in the volume of diuresis, Tachycardia, Coagulopathy, Metabolic acidosis, Lactate elevation.

• Septic shock: arterial hypotension that persists after resuscitation volume and that requires vasopressors to maintain MAP> 65 mmHg and lactate> 2 mmol / L (18 mg / dL) in the absence of hypovolemia.

Exclusion Criteria:

• Negative laboratory diagnostic test for COVID-19, before randomization.

• Pregnancy.

• History of allergic reactions attributed to polyphenol type compounds similar to those found in green tea.