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

NCT05096052 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2022-03-09

No results posted yet for this study

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

Interventions

DRUG

Galactomannan

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

DRUG

PLACEBO

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

Sponsors & Collaborators

  • ALKE RESEARCH PRIVATE LIMITED

    collaborator UNKNOWN

  • Research Consultancy

    collaborator UNKNOWN

  • Bioxytran Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-07-31
Completion
2022-09-25
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05096052 on ClinicalTrials.gov