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

Primary Purpose

COVID-19, SARS CoV 2 Infection

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prolectin-M
Sponsored by
Bioxytran Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Patients must meet all of the following criteria to be included in this study. 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Change In Clinical Status
    Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2

    Secondary Outcome Measures

    Safety Outcome
    Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities.
    Safety Outcome
    Proportion of participants with TEAEs leading to study treatment discontinuation
    Mortality
    Mortality rate by Day 14
    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
    Time to discharge of viral load
    Time to negative SARS-CoV-2 polymerase chain reaction (PCR)
    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
    Safety Outcome
    Rate of adverse events
    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

    Full Information

    First Posted
    December 26, 2022
    Last Updated
    September 26, 2023
    Sponsor
    Bioxytran Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05733780
    Brief Title
    To Evaluate the Safety, Efficacy,and Pharmacokinetics of Orally Administered Prolectin-M
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bioxytran Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, SARS CoV 2 Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    A Phase 1b/2a Randomized, Blinded, placebo-controlled Study
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg
    Arm Title
    Arm 2
    Arm Type
    Experimental
    Arm Description
    ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg
    Arm Title
    Arm 3
    Arm Type
    Experimental
    Arm Description
    ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800
    Arm Title
    Arm 4
    Arm Type
    No Intervention
    Arm Description
    Matching Placebo. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Prolectin-M
    Other Intervention Name(s)
    Galactomannan
    Intervention Description
    Prolectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus
    Primary Outcome Measure Information:
    Title
    Change In Clinical Status
    Description
    Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
    Time Frame
    Day 7
    Secondary Outcome Measure Information:
    Title
    Safety Outcome
    Description
    Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities.
    Time Frame
    from time of signing informed consent till day 14
    Title
    Safety Outcome
    Description
    Proportion of participants with TEAEs leading to study treatment discontinuation
    Time Frame
    from time of signing informed consent till day 14
    Title
    Mortality
    Description
    Mortality rate by Day 14
    Time Frame
    from time of signing informed consent till day 14
    Title
    Plasma Concentration of PL-M
    Description
    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
    Time Frame
    Day 7
    Title
    Time to discharge of viral load
    Description
    Time to negative SARS-CoV-2 polymerase chain reaction (PCR)
    Time Frame
    from time of signing informed consent till day 14
    Title
    Change in Clinical Status from Baseline to End of the study
    Description
    Time to alleviation (absent) of baseline COVID- 19 symptoms as reported on the WHO clinical progression scale
    Time Frame
    from time of signing informed consent till day 14
    Title
    Safety Outcome
    Description
    Rate of adverse events
    Time Frame
    from time of signing informed consent till day 14
    Title
    Change in Clinical Status
    Description
    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
    Time Frame
    Day 3 and Day 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:Patients must meet all of the following criteria to be included in this study. 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mr.Srivatsa GS
    Phone
    6364147989
    Email
    sri@samahitha.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ms.Keertana Shetty
    Phone
    6364149749
    Email
    hr@samahitha.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sunitha Mali
    Organizational Affiliation
    Team Lead
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The sponsors and the study representatives and other stakeholders will take a decision on completion of the trial

    Learn more about this trial

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

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