PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A galectin inhibitor that prevents viral replication of the Sars-CoV-2 virus through blocking the specific terminal on the surface that enables the virus to enter human cells. This inhibitor - ProLectin M is a novel substance that is given orally to individuals who have an infection with Sars-CoV-2 or COVID19 disease. The oral tablet is chewed every hour for the first 14 days. We hypothesise that patients receiving the active investigational product (ProLectinM) will have a faster recovery from COVID19 compared to those receiving its matching placebo. The trial is approved by Institutional Review Board for safety and all participants will need to provide a written informed consent to volunteer in this trial. The safety of ProLectin is established as the drug substance is recognised as a safe substance. However its benefits in relieving patients from the COVID19 infection and providing the patients faster recovery from its clinical symptoms and prevention of delayed sequelae of the infection has not been proven yet.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioxytran Inc.
• Collaborators: ALKE RESEARCH PRIVATE LIMITED; Research Consultancy

Criteria

Inclusion Criteria:

• 1. 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.

2. 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.

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:

• 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.