Antioxidants, and particularly polyphenols, have shown protection in respiratorypathologies, which is related to the decrease in the severity of the clinical picture andsuppression of inflammation. This suppression of inflammation may be related to theinhibition of NF-kB polyphenols, where its activation is related to the stimulation of150 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 respiratorypathologies, among which are the regulation of reactive oxygen species (ROS) associatedwith tissue destruction caused by the virus and a selective antiviral action can bereported. direct.The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of thePontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation andtissue damage and induces complete autophagy in stressed or tumor cells. The induction ofa full autophagic flow could inhibit the replication of beta-coronaviruses likeSARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage byreducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases(unpublished data).These antecedents suggest that the supplementation of patients with COVID-19 with theextract P2Et, could improve their general condition and decrease the inflammatorymediators 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