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

NCT05096052 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: ALKE20001
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  14 days

• 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

  14 days

Secondary Outcomes (3)

• time to discharge or to a NEWS of ≤ 2

  29 days

• Duration of hospitalisation

  29 Days

• mortality / Serious adverse events

  29 Days

Study Arms (2)

ProLectin M

EXPERIMENTAL

Active chewable tablets containing galectin inhibitor complex carbohydrate

Drug: Galactomannan

PLACEBO

PLACEBO COMPARATOR

Placebo chewable tablets not containing galectin inhibitor complex carbohydrate

Drug: PLACEBO

Interventions

Galactomannan DRUG

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

ProLectin M

PLACEBO DRUG

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

PLACEBO

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 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

You may not qualify if:

• \. 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.
• \. 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.
• \. Patients with known allergies to any of the components used in the formulation of the interventions.

Sponsors & Collaborators

• Bioxytran Inc.: lead
• ALKE RESEARCH PRIVATE LIMITED: collaborator
• Research Consultancy: collaborator

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

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; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

ALBEN SIGAMANI, MD

CONTACT

00918884431444; dralbens@myrescon.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant MD Physician

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 27, 2021
• Study Start: April 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: September 25, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03