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Completed

NCT Number: NCT04512027

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, 560099, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other

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

Primary outcomes

  1. SarsCoV2 viral copy number

    Time frame: 7 days from randomisation

    Change in absolute viral copy number

Secondary outcomes

  1. b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.

    Time frame: 28 days from randomisation

    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

Sponsors and collaborators

Lead sponsor

Composite Interceptive Med Science

Industry

Collaborators

  • Bioxytran Inc.

Registry information

Official study title

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

Acronym: Prolectin-M

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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