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

NCT04410510 | Unknown Phase 2

• 1 other identifier: CS002-COVID19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).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

Conditions

COVID; Coronavirus Infection; SARS-CoV 2; COVID19

Keywords

Herbal Drug; P2Et; Caesalpinia spinosa; Coronavirus; COVID19

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19

  Proportion of patients who reduce the time in the hospital

  30 days

Secondary Outcomes (6)

• Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19

  30 days

• Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment

  30 days

• Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment

  30 days

• Efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.

  30 days

• Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.

  30 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

Lopinavir / ritonavir \* Capsules 200/50 mg 400/100 mg every 12 hours for 7 to 14 days Hydroxychloroquine \* Tab 200 mg Tab Load 400 mg every 12 hours the first day, follow 200 mg every 12 hours for 10 days Placebo capsule equivalent to 250mg of excipient every 12 hours for 14 days

Other: Placebo

Intervention group

EXPERIMENTAL

Lopinavir / ritonavir \* Capsules 200/50 mg 400/100 mg every 12 hours for 7 to 14 days Hydroxychloroquine \* Tab 200 mg Tab Load 400 mg every 12 hours the first day, follow 200 mg every 12 hours for 10 days P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days

Drug: P2Et (Caesalpinia spinosa extract)

Interventions

P2Et (Caesalpinia spinosa extract) DRUG

P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care

Intervention group

Placebo OTHER

Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 mmHg \<PaO2 / FiO2 \<300 mmHg. Moderate: 100 mmHg \<PaO2 / FiO2 \<200 mmHg. Serious: PaO2 / FiO2 \<100 mmHg. If PaO2 not available 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Colombia

RECRUITING

Related Publications (1)

• Uruena C, Ballesteros-Ramirez R, Gomez-Cadena A, Barreto A, Prieto K, Quijano S, Aschner P, Martinez 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. eCollection 2022.

  PMID: 36160152 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Margarita Manrrique, MD, MSc

CONTACT

5946161; mmmanrique@husi.org.co

Angel Garcia, MD. MSc. PhD(c)

CONTACT

3208320; aagarcia@husi.org.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 100 patients will be randomized in a 1: 1 ratio (50 in each group)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of P2Et (Caesalpinia spinosa extract) treatment in patients with a clinical diagnosis of Covid-19 infection when added to standard therapy.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: September 30, 2020
• Primary Completion: June 30, 2021
• Study Completion: November 30, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

CO (1)