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

NCT05733780 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CTSRS/2205
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (1)

• Change In Clinical Status

  Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2

  Day 7

Secondary Outcomes (8)

• Safety Outcome

  from time of signing informed consent till day 14

• Safety Outcome

  from time of signing informed consent till day 14

• Mortality

  from time of signing informed consent till day 14

• Plasma Concentration of PL-M

  Day 7

• Time to discharge of viral load

  from time of signing informed consent till day 14

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Drug: Prolectin-M

Arm 2

EXPERIMENTAL

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

Drug: Prolectin-M

Arm 3

EXPERIMENTAL

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

Drug: Prolectin-M

Arm 4

NO INTERVENTION

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

Interventions

Prolectin-M 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

Also known as: Galactomannan

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from this study.
• Oxygen Saturation levels (SpO2) ≤ 94% on room air.
• Female subjects who are pregnant or breastfeeding.
• Subjects with any active malignancy or undergoing active chemotherapy.
• Subjects who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
• Subjects with a history of hypercalcemia or serum calcium concentration \>10mg/dl
• Subjects currently on concomitant medication that can contains calcium, elevate serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics etc.).
• 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.)
• 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.
• Subjects with known allergies to any of the components used in the formulation of the interventions.

Sponsors & Collaborators

• Bioxytran Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

galactomannan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sunitha Mali

  Team Lead

  STUDY CHAIR

Central Study Contacts

Mr.Srivatsa GS

CONTACT

6364147989; sri@samahitha.com

Ms.Keertana Shetty

CONTACT

6364149749; hr@samahitha.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinding will be maintained throughout the trial until database is locked after last patient last visit. Emergency unblinding will be allowed through a 24/7 helpline set up for any investigator / ethics committee member or others authorized to request for unblinding. Given
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 1b/2a Randomized, Blinded, placebo-controlled Study

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 17, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share