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PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19 (PROTECT)

Primary Purpose

COVID-19, COVID-19 Pandemic, COVID-19 Respiratory Infection

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Galactomannan

PLACEBO

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

Male or Female patient of ≥ 18 years of age, regardless of vaccine status or viral variant or underlying medical conditions, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule.
Patient having a positive diagnosis for the presence of SARS-CoV-2, obtained from a recently performed rRT-PCR (≤ 3 days) with any 1 of the following:
i. Ct value ≤ 25 ii. Hospitalized for having classical (CDC defined) symptoms of COVID-19 (onset ≤ 5 days) iii. High risk category of COVID-19: blood group type A-positive type 2 diabetes, or other chronic disease known to have higher morbidity risk with SARS-CoV-2 infection.
Patient has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated swab collections and frequent follow up for 29 days.
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:

5. Oxygen Saturation levels (SpO2) ≤ 94% on room air. 6. Female patients who are pregnant or breastfeeding. 7. Patients with any active malignancy or undergoing active chemotherapy. 8. Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
9. In the opinion of the Investigator, the participation of the patient in the study is not in the patient's best interest, or the patient has any medical condition that does not allow the study protocol to be followed safely.
10. Patients 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 Type

Experimental

Placebo Comparator

Arm Label

ProLectin M

PLACEBO

Arm Description

Active chewable tablets containing galectin inhibitor complex carbohydrate

Placebo chewable tablets not containing galectin inhibitor complex carbohydrate

Outcomes

Primary Outcome Measures

Change in seropositivity from baseline for-detection of viral shedding

detecting quantitative SARS-CoV-2 in nasopharynx at intervals of days 1,2, 3, 5, 7, 9 and 14

Change in clinical status from baseline

Proportion of patients reporting improvement in their disease on a WHO Clinical Progression Scale measured daily over the course of the study

Secondary Outcome Measures

time to discharge or to a NEWS of ≤ 2

Duration of hospitalisation

mortality / Serious adverse events

Full Information

NCT ID

NCT05096052

First Posted

October 21, 2021

Last Updated

March 4, 2022

Sponsor

Bioxytran Inc.

Collaborators

ALKE RESEARCH PRIVATE LIMITED, Research Consultancy

1. Study Identification

Unique Protocol Identification Number

NCT05096052

Brief Title

PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19

Acronym

PROTECT

Official Title

PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety Among Asymptomatic to Moderately-severe, Ambulatory Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

September 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bioxytran Inc.

Collaborators

ALKE RESEARCH PRIVATE LIMITED, Research Consultancy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A galectin antagonist prevents viral entry of Sars-CoV-2 virus by blocking the specific terminal on the surface receptors that enables the virus to enter human cells. This inhibitor - ProLectin M is a novel substance that is given orally to individuals who have an infection with Sars-CoV-2 or its subsequent mutations causing COVID19 disease. The oral tablet is chewed every hour, for 8 hours daily, for 7 days. We hypothesize that patients receiving the active investigational product (ProLectin M), irrespective of their vaccination status, or underlying medical conditions, will have a faster recovery from COVID19 compared to those receiving its matching placebo. The trial is approved by an Institutional Review Board for safety and all participants will need to provide written informed consent to participate in this trial. The safety of ProLectin M is established as the drug substance is recognised as a safe substance. However, its benefits in relieving patients from the COVID19 infection and providing the patients faster recovery from its clinical symptoms and prevention of delayed sequelae of the infection has not been proven yet.

Detailed Description

SarsCov2 causes inflammation by releasing cytokines. This is caused by the expressed galectins which are immunogenic. Binding of the virus to human galectins also give it a very unique property to stealthily avoid the human innate immune system. This is the reason why even present day vaccines are failing to prevent spread of infections. In this background, our investigational drug has the unique ability to mimic human Galectin 3 and prevent viral entry into host cells. This makes the virus vulnerable to our natural innate immune system to clear it from the oro pharyngeal and GITract. Randomizing patients into active and placebo groups in a blinded placebo controlled trial can provide us evidence on the ability of ProLectin M to eliminate the virus and prevent even spread of the virus in the community. This also will demonstrate for the first time, how carbohydrates can be used to block significantly infection causing viruses in human beings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, COVID-19 Pandemic, COVID-19 Respiratory Infection, SARS-CoV2 Infection, Cytokine Release Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ProLectin M

Arm Type

Experimental

Arm Description

Active chewable tablets containing galectin inhibitor complex carbohydrate

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

Placebo chewable tablets not containing galectin inhibitor complex carbohydrate

Intervention Type

Drug

Intervention Name(s)

Galactomannan

Intervention Description

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

Intervention Name(s)

PLACEBO

Intervention Description

A blinded matching placebo containing inert chemistry not able to recognise and bind to the galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus

Primary Outcome Measure Information:

Title

Change in seropositivity from baseline for-detection of viral shedding

Description

detecting quantitative SARS-CoV-2 in nasopharynx at intervals of days 1,2, 3, 5, 7, 9 and 14

Time Frame

14 days

Title

Change in clinical status from baseline

Description

Proportion of patients reporting improvement in their disease on a WHO Clinical Progression Scale measured daily over the course of the study

Time Frame

14 days

Secondary Outcome Measure Information:

Title

time to discharge or to a NEWS of ≤ 2

Time Frame

29 days

Title

Duration of hospitalisation

Time Frame

29 Days

Title

mortality / Serious adverse events

Time Frame

29 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or Female patient of ≥ 18 years of age, regardless of vaccine status or viral variant or underlying medical conditions, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule. Patient having a positive diagnosis for the presence of SARS-CoV-2, obtained from a recently performed rRT-PCR (≤ 3 days) with any 1 of the following: i. Ct value ≤ 25 ii. Hospitalized for having classical (CDC defined) symptoms of COVID-19 (onset ≤ 5 days) iii. High risk category of COVID-19: blood group type A-positive type 2 diabetes, or other chronic disease known to have higher morbidity risk with SARS-CoV-2 infection. Patient has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated swab collections and frequent follow up for 29 days. 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: 5. Oxygen Saturation levels (SpO2) ≤ 94% on room air. 6. Female patients who are pregnant or breastfeeding. 7. Patients with any active malignancy or undergoing active chemotherapy. 8. Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening. 9. In the opinion of the Investigator, the participation of the patient in the study is not in the patient's best interest, or the patient has any medical condition that does not allow the study protocol to be followed safely. 10. Patients 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

ALBEN SIGAMANI, MD

Phone

00918884431444

dralbens@myrescon.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19

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