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

NCT ID: NCT05733780

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-02-29

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.

Conditions

COVID-19; SARS CoV 2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg

Group Type: EXPERIMENTAL

Prolectin-M

Intervention Type: DRUG

Prolectin-M

Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus

Arm 2

ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg

Group Type: EXPERIMENTAL

Prolectin-M

Intervention Type: DRUG

Prolectin-M

Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus

Arm 3

ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800

Group Type: EXPERIMENTAL

Prolectin-M

Intervention Type: DRUG

Prolectin-M

Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus

Arm 4

Matching Placebo. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prolectin-M

Prolectin-M

Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus

Intervention Type: DRUG

Other Intervention Names

Galactomannan

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioxytran Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunitha Mali

Role: STUDY_CHAIR

Team Lead

Central Contacts

Mr.Srivatsa GS

Role: CONTACT

sri@samahitha.com

6364147989

Ms.Keertana Shetty

Role: CONTACT

hr@samahitha.com

6364149749

Other Identifiers

CTSRS/2205

Identifier Type: -

Identifier Source: org_study_id