A galectin antagonist prevents viral entry of Sars-CoV-2 virus by blocking the specificterminal on the surface receptors that enables the virus to enter human cells. Thisinhibitor - ProLectin M is a novel substance that is given orally to individuals who havean infection with Sars-CoV-2 or its subsequent mutations causing COVID19 disease. Theoral tablet is chewed every hour, for 8 hours daily, for 7 days.We hypothesize that patients receiving the active investigational product (ProLectin M),irrespective of their vaccination status, or underlying medical conditions, will have afaster recovery from COVID19 compared to those receiving its matching placebo. The trialis approved by an Institutional Review Board for safety and all participants will need toprovide written informed consent to participate in this trial. The safety of ProLectin Mis established as the drug substance is recognised as a safe substance. However, itsbenefits in relieving patients from the COVID19 infection and providing the patientsfaster recovery from its clinical symptoms and prevention of delayed sequelae of theinfection has not been proven yet.
SarsCov2 causes inflammation by releasing cytokines. This is caused by the expressed
galectins which are immunogenic.
Binding of the virus to human galectins also give it a very unique property to stealthily
avoid the human innate immune system. This is the reason why even present day vaccines
are failing to prevent spread of infections.
In this background, our investigational drug has the unique ability to mimic human
Galectin 3 and prevent viral entry into host cells. This makes the virus vulnerable to
our natural innate immune system to clear it from the oro pharyngeal and GITract.
Randomizing patients into active and placebo groups in a blinded placebo controlled trial
can provide us evidence on the ability of ProLectin M to eliminate the virus and prevent
even spread of the virus in the community. This also will demonstrate for the first time,
how carbohydrates can be used to block significantly infection causing viruses in human
beings.
Drug: Galactomannan
Precise chemistry based molecule that binds to galectin like receptors on the N terminal
of S1 subunit of the Sars-CoV2 virus
Drug: PLACEBO
A blinded matching placebo containing inert chemistry not able to recognise and bind to
the galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus
Inclusion Criteria:
1. Male or Female patient of ≥ 18 years of age, regardless of vaccine status or viral
variant or underlying medical conditions, willing and able to provide written
informed consent for participation in the study and ready to comply with the study
procedures and schedule.
2. Patient having a positive diagnosis for the presence of SARS-CoV-2, obtained from a
recently performed rRT-PCR (≤ 3 days) with any 1 of the following:
i. Ct value ≤ 25 ii. Hospitalized for having classical (CDC defined) symptoms of
COVID-19 (onset ≤ 5 days) iii. High risk category of COVID-19: blood group type
A-positive type 2 diabetes, or other chronic disease known to have higher morbidity
risk with SARS-CoV-2 infection.
3. Patient has the ability to take oral medication and be willing to adhere to the
trial protocol regimen of repeated swab collections and frequent follow up for 29
days.
4. Females of child bearing potential who has been using a highly effective
contraception for at least 1 month prior to screening and agrees to continue using
it during the study participation/enrolment, confirmed through negative pregnancy
test
Exclusion Criteria:
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5. Oxygen Saturation levels (SpO2) ≤ 94% on room air. 6. Female patients who are
pregnant or breastfeeding. 7. Patients with any active malignancy or undergoing
active chemotherapy. 8. Patients who are currently receiving or have received
any investigational treatment for COVID-19 within 30 days prior to screening.
9. In the opinion of the Investigator, the participation of the patient in the
study is not in the patient's best interest, or the patient has any medical
condition that does not allow the study protocol to be followed safely.
10. Patients with known allergies to any of the components used in the formulation
of the interventions.
Not Provided
ALBEN SIGAMANI, MD
00918884431444
dralbens@myrescon.com
Not Provided