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

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ClinicalTrials.gov Identifier: NCT04410510
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Pontificia Universidad Javeriana
Information provided by (Responsible Party):
Hospital Universitario San Ignacio

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involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).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


Condition or disease Intervention/treatment Phase
COVID Coronavirus Infection SARS-CoV 2 COVID19 Drug: P2Et (Caesalpinia spinosa extract) Other: Placebo Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 100 patients will be randomized in a 1: 1 ratio (50 in each group)
Primary Purpose: Supportive Care
Official Title: 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.
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
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
Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care

Experimental: Intervention group
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)
P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care




Primary Outcome Measures :
  1. Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19 [ Time Frame: 30 days ]
    Proportion of patients who reduce the time in the hospital


Secondary Outcome Measures :
  1. Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19 [ Time Frame: 30 days ]
    Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19

  2. Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment [ Time Frame: 30 days ]
    Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment

  3. Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment [ Time Frame: 30 days ]
    Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment

  4. 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. [ Time Frame: 30 days ]
    Assess the 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.

  5. Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease. [ Time Frame: 30 days ]
    Evaluate the efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.

  6. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19 [ Time Frame: 30 days ]
    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410510


Contacts
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Contact: Margarita Manrrique, MD, MSc 5946161 ext 2475 mmmanrique@husi.org.co
Contact: Angel Garcia, MD. MSc. PhD(c) 3208320 ext 4025 aagarcia@husi.org.co

Locations
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Colombia
Hospital Universitario San Ignacio Recruiting
Bogotá, Colombia
Contact: Ivonne Sabogal, BSc         
Sponsors and Collaborators
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
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Responsible Party: Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT04410510    
Other Study ID Numbers: CS002-COVID19
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitario San Ignacio:
Herbal Drug
P2Et
Caesalpinia spinosa
Coronavirus
COVID19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases