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

Effect of Prolectin-M; a (1-6)-Alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A Proof of Concept, Open Label Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Mazumdar Shaw Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care; Tablet chewed for 5 days along and given alongside standard of care	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.
No Intervention: Standard of Care; All patients will receive currently practiced standard of care medicines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SarsCoV2 viral copy number	Change in absolute viral copy number	7 days from randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.	7-point severity score (ordinal scale): Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities;; Hospitalized, not requiring supplemental oxygen;; Hospitalized, requiring supplemental oxygen;; Hospitalized, on non-invasive ventilation or high flow oxygen devices;; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);; Death	28 days from randomisation

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Collaborators: Bioxytran Inc.

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): September 19, 2020
• Study Completion (Actual): October 16, 2020

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ddPCR,; SarsCoV2 Copies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CIMED - 002- 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No