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

Composite Interceptive Med Science

Status

Completed

Conditions

COVID-19

Treatments

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

Other: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT04512027

CIMED - 002- 2020

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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