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factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).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.
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
Drug: P2Et (Caesalpinia spinosa extract)
P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care
Other: Placebo
Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care
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
- 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.
Hospital Universitario San Ignacio
Bogotá, Colombia
Investigator: Ivonne Sabogal, BSc
Margarita Manrrique, MD, MSc
5946161 - 2475
mmmanrique@husi.org.co
Angel Garcia, MD. MSc. PhD(c)
3208320 - 4025
aagarcia@husi.org.co