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

Primary Purpose

COVID, Coronavirus Infection, SARS-CoV 2

Status
Unknown status
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
P2Et (Caesalpinia spinosa extract)
Placebo
Sponsored by
Hospital Universitario San Ignacio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID focused on measuring Herbal Drug, P2Et, Caesalpinia spinosa, Coronavirus, COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario San IgnacioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19
Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19
Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment
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
Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment
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
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.
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.
Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.
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.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19

Full Information

First Posted
May 27, 2020
Last Updated
August 6, 2021
Sponsor
Hospital Universitario San Ignacio
Collaborators
Pontificia Universidad Javeriana
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1. Study Identification

Unique Protocol Identification Number
NCT04410510
Brief Title
P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario San Ignacio
Collaborators
Pontificia Universidad Javeriana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Coronavirus Infection, SARS-CoV 2, COVID19
Keywords
Herbal Drug, P2Et, Caesalpinia spinosa, Coronavirus, COVID19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
100 patients will be randomized in a 1: 1 ratio (50 in each group)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
P2Et (Caesalpinia spinosa extract)
Intervention Description
P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care
Primary Outcome Measure Information:
Title
Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19
Description
Proportion of patients who reduce the time in the hospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19
Description
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
Title
Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment
Description
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
Time Frame
30 days
Title
Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment
Description
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
Time Frame
30 days
Title
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.
Description
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.
Time Frame
30 days
Title
Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.
Description
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.
Time Frame
30 days
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19
Description
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margarita Manrrique, MD, MSc
Phone
5946161
Ext
2475
Email
mmmanrique@husi.org.co
First Name & Middle Initial & Last Name or Official Title & Degree
Angel Garcia, MD. MSc. PhD(c)
Phone
3208320
Ext
4025
Email
aagarcia@husi.org.co
Facility Information:
Facility Name
Hospital Universitario San Ignacio
City
Bogotá
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivonne Sabogal, BSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36160152
Citation
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.
Results Reference
derived

Learn more about this trial

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

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