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

Phase 2

Not yet recruiting

• Conditions: COVID-19; SARS CoV 2 Infection
• Interventions: Drug: Prolectin-M

• Registration Number: NCT05733780
• Lead Sponsor: Bioxytran Inc.

Brief Summary

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.

Detailed Description

This trial will test the efficacy of ProLectin M in lowering viral load among those infected with SARS-CoV-2. Viral load will be measured using nucleic acid amplification-based diagnostics, RT-PCR. The RT-PCR will measure an absolute increase in cycle threshold values from baseline.

ProLectin M (a guar gum galactomannan), an oral form of galectin antagonist could treat COVID-19 patients. When given early in the disease pathogenesis and the viral replication is stopped, it can prevent further spread of SARS-CoV-2 among the household contacts and their community.

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Status Verified: 2023-09
• Study Start: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2023-12
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Prolectin-M	ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg
Arm 2	Prolectin-M	ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg
Arm 3	Prolectin-M	ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800

Primary Outcome Measures

Name	Time	Method
Change In Clinical Status	Day 7	Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
Time to discharge of viral load	from time of signing informed consent till day 14	Time to negative SARS-CoV-2 polymerase chain reaction (PCR)
Mortality	from time of signing informed consent till day 14	Mortality rate by Day 14
Plasma Concentration of PL-M	Day 7	Characterization of the plasma concentrations of ProLectin-M and its metabolites including AUC0 24h, AUClast, CLss/F, t1/2, Vz/F, Cmax, Tmax, Clast, Tlast, AUCtau, λz, and Ctau
Change in Clinical Status	Day 3 and Day 5	Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2 Outcome TimePoints Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
Change in Clinical Status from Baseline to End of the study	from time of signing informed consent till day 14	Time to alleviation (absent) of baseline COVID- 19 symptoms as reported on the WHO clinical progression scale
Safety Outcome	from time of signing informed consent till day 14	Rate of adverse events