- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512027
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karnataka
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Bangalore, Karnataka, India, 560099
- Mazumdar Shaw Medical centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
A treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19
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
Time Frame: 7 days from randomisation
|
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.
Time Frame: 28 days from randomisation
|
7-point severity score (ordinal scale):
|
28 days from randomisation
|
Collaborators and Investigators
Collaborators
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIMED - 002- 2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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