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

A Phase 1b/2a Randomized, Blinded, Placebo-controlled Study in Participants With Mild to Moderate COVID-19 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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; SARS CoV 2 Infection
• Intervention / Treatment: Drug: Prolectin-M

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mr.Srivatsa GS; Phone Number: 6364147989; Email: sri@samahitha.com
• Study Contact Backup: Name: Ms.Keertana Shetty; Phone Number: 6364149749; Email: hr@samahitha.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg	Drug: 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; Other Names: Galactomannan
Experimental: Arm 2; ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg	Drug: 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; Other Names: Galactomannan
Experimental: Arm 3; ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800	Drug: 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; Other Names: Galactomannan
No Intervention: Arm 4; Matching Placebo. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In Clinical Status	Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of PL-M	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	Day 7
Safety Outcome	Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities.	from time of signing informed consent till day 14
Safety Outcome	Proportion of participants with TEAEs leading to study treatment discontinuation	from time of signing informed consent till day 14
Mortality	Mortality rate by Day 14	from time of signing informed consent till day 14
Time to discharge of viral load	Time to negative SARS-CoV-2 polymerase chain reaction (PCR)	from time of signing informed consent till day 14
Change in Clinical Status from Baseline to End of the study	Time to alleviation (absent) of baseline COVID- 19 symptoms as reported on the WHO clinical progression scale	from time of signing informed consent till day 14
Safety Outcome	Rate of adverse events	from time of signing informed consent till day 14
Change in Clinical Status	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	Day 3 and Day 5

Collaborators and Investigators

• Sponsor: Bioxytran Inc.
• Investigators: Study Chair: Sunitha Mali, Team Lead

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CTSRS/2205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsors and the study representatives and other stakeholders will take a decision on completion of the trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No