NCT05096052

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Bioxytran Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-07-31
• Completion: 2022-09-25
• First posted: 2021-10-27
• Last updated: 2022-03-09

Regulatory

• FDA-regulated drug study