Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support. (Prolectin-M)
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|ClinicalTrials.gov Identifier: NCT04512027|
Recruitment Status : Completed
First Posted : August 13, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class Other: Standard of Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||September 15, 2020|
|Actual Primary Completion Date :||September 19, 2020|
|Actual Study Completion Date :||October 16, 2020|
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
- SarsCoV2 viral copy number [ Time Frame: 7 days from randomisation ]Change in absolute viral copy number
- 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);
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512027
|Mazumdar Shaw Medical Centre|
|Bangalore, Karnataka, India, 560099|