Trials / Completed
CompletedNCT04512027
Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.
Effect of Prolectin-M; a (1-6)-Alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A Proof of Concept, Open Label Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Composite Interceptive Med Science · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-09-15
- Primary completion
- 2020-09-19
- Completion
- 2020-10-16
- First posted
- 2020-08-13
- Last updated
- 2020-10-19
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT04512027. Inclusion in this directory is not an endorsement.