Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.

NCT ID: NCT04512027

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2020-10-16

Brief Summary

A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.

Detailed Description

SarsCoV2 has infected over 20 million people worldwide. The virus has a unique protein structure enabling it to rapidly infect and spread among the population. COVID19 is a global health emergency and has affected lives of all people irrespective of being infected. There are no proven therapies and a vaccine is yet to be approved for wide public usage.

Our study aims to test a hypothesis of physically blocking the spike protein from infecting the human cells, thus promoting its rapid excretion from the infected person.

We will randomise 10 subjects in this proof of concept trial and test the hypothesis by measuring the effect of Prolectin-M; a (1-6)-alpha-D-Mannopyranose in reducing the viral copy numbers over 5 days of treatment. The absolute copy numbers will be measured on digital droplet PCR developed by BioRad. A fall in copy numbers by 2-fold from baseline will be considered a positive treatment effect in this population. All standard care measures currently being practiced for these patients will be continued.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care

Tablet chewed for 5 days along and given alongside standard of care

Group Type: EXPERIMENTAL

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class

Intervention Type: OTHER

A treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19

Standard of Care

Intervention Type: OTHER

Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.

Standard of Care

All patients will receive currently practiced standard of care medicines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class

A treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19

Intervention Type: OTHER

Standard of Care

Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Symptomatic and laboratory-confirmed diagnosis of COVID-19.
• Age ≥18 years and ≤45 years, male and non-pregnant female
• Identified within 72 hours of testing positive on RT PCR.
• Able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; Day 1, Day 3 and Day 5 since randomization.

Exclusion Criteria

• Oxygen saturation at admission ≤96%.
• High temperature ≥100 deg F (≥37.5 deg C) not controlled on oral doses of acetaminophen.
• Known history of diabetes on oral medications or insulin.
• IL-6 levels ≥ 3times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer.
• Lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter
• On any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression.
• Previously tested positive and recovered from COVID-19

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioxytran Inc.

INDUSTRY

Sponsor Role: collaborator

Composite Interceptive Med Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, India

Countries

India

References

Suo T, Liu X, Feng J, Guo M, Hu W, Guo D, Ullah H, Yang Y, Zhang Q, Wang X, Sajid M, Huang Z, Deng L, Chen T, Liu F, Xu K, Liu Y, Zhang Q, Liu Y, Xiong Y, Chen G, Lan K, Chen Y. ddPCR: a more accurate tool for SARS-CoV-2 detection in low viral load specimens. Emerg Microbes Infect. 2020 Dec;9(1):1259-1268. doi: 10.1080/22221751.2020.1772678.

Reference Type: BACKGROUND

PMID: 32438868 (View on PubMed)

http://medrxiv.org/lookup/doi/10.1101/2020.02.29.20029439

Reference Type: BACKGROUND

Other Identifiers

CIMED - 002- 2020

Identifier Type: -

Identifier Source: org_study_id