To Evaluate the Safety, Efficacy,and Pharmacokinetics of Orally Administered Prolectin-M

ProLectin M is an orally administered polysaccharide. Polysaccharides competitively bind to the N-terminal tail of human galectin-3 through a proline isomerization [10]. Galetin-3 (Gal-3) is 1 among the 15 galectins described in humans and also a ubiquitous human galectin expressed in various disease pathogenesis pathways [11].The objective of this clinical study is to evaluate the safety and efficacy of a galectin antagonist, ProLectin M (a Guar Gum Galactomannan), in the treatment of subjects with asymptomatic to moderately-severe, ambulatory COVID-19 patients.

Inclusion Criteria:Patients must meet all of the following criteria to be included in this study.Male or Female patient of ≥ 18 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule.Patient having a positive diagnosis for 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.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 10 days.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:Patients who meet any of the following criteria will be excluded from this study.Oxygen Saturation levels (SpO2) ≤ 94% on room air.Female patients who are pregnant or breastfeeding.Patients with any active malignancy or undergoing active chemotherapy.Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.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.Patients with known allergies to any of the components used in the formulation of the interventions.