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

Launched by BIOXYTRAN INC. · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called ProLectin M, which is being tested for its safety and effectiveness in treating people with mild to moderate COVID-19. ProLectin M works by targeting a specific protein in the body called galectin-3, which is involved in various health issues. The goal of the study is to see if this medication can help patients who have tested positive for the virus and are not severely ill.

To participate, individuals must be at least 18 years old, have a recent positive COVID-19 test, and be able to take oral medications. They will need to follow the study schedule, which includes taking the medication and undergoing some tests for up to 14 days. However, certain people, such as those with low oxygen levels, pregnant or breastfeeding women, and those on specific medications that could interfere with the study, will not be eligible. If you or a loved one might be interested in participating, the study is currently not recruiting, but it’s important to stay informed about when it will begin.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria:Patients must meet all of the following criteria to be included in this study.
• • 1. Male or Female subject 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. Subject having a positive diagnosis for presence of SARS-CoV- 2, obtained from a recently performed RT-PCR (≤ 3 days) with a Ct value ≤ 25.
• • 3. Subject has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated nasopharyngeal swab collections and follow up till day 14.
• • 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:
• • Patients who meet any of the following criteria will be excluded from this study.
• • 1. Oxygen Saturation levels (SpO2) ≤ 94% on room air.
• • 2. Female subjects who are pregnant or breastfeeding.
• • 3. Subjects with any active malignancy or undergoing active chemotherapy.
• • 4. Subjects who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
• • 5. Subjects with a history of hypercalcemia or serum calcium concentration \>10mg/dl
• • 6. Subjects currently on concomitant medication that can contains calcium, elevate serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics etc.).
• • 7. Subjects currently on calcium-binding (chelation) concomitant medication that may result in reduction in absorption (e.g. fluroquinolone, bisphosphonates, antivirals such as integrase strand transfer inhibitors, antibiotics such as quinolones, tetracyclines etc.)
• • 8. In the opinion of the Investigator, the participation of the subject in the study is not in the subject's best interest, or the subject has any medical condition that does not allow the study protocol to be followed safely.
• • 9. Subjects with known allergies to any of the components used in the formulation of the interventions.