Status:
COMPLETED
Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.
Lead Sponsor:
Composite Interceptive Med Science
Collaborating Sponsors:
Bioxytran Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04512027
Start Date
September 15 2020
End Date
October 16 2020
Last Update
October 19 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, India, 560099