A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.
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.
Other: 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
Other: Standard of Care
Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.
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
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, India