Status:
UNKNOWN
P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19
Lead Sponsor:
Hospital Universitario San Ignacio
Collaborating Sponsors:
Pontificia Universidad Javeriana
Conditions:
COVID
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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. ...
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 phytomedici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04410510
Start Date
September 30 2020
End Date
November 30 2021
Last Update
August 10 2021
Active Locations (1)
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1
Hospital Universitario San Ignacio
Bogotá, Colombia