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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
Sponsor:
Collaborator:
Pharmalectin Inc
Information provided by (Responsible Party):
Composite Interceptive Med Science

Tracking Information
First Submitted Date  ICMJE August 11, 2020
First Posted Date  ICMJE August 13, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE September 15, 2020
Actual Primary Completion Date September 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
SarsCoV2 viral copy number [ Time Frame: 7 days from randomisation ]
Change in absolute viral copy number
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2020)
Viral copy number [ Time Frame: 5 days ]
decrease in viral copy numbers
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
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):
  1. Not hospitalized, no limitations on activities
  2. Not hospitalized, limitation on activities;
  3. Hospitalized, not requiring supplemental oxygen;
  4. Hospitalized, requiring supplemental oxygen;
  5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
  6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
  7. Death
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.
Official Title  ICMJE Effect of Prolectin-M; a (1-6)-Alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A Proof of Concept, Open Label Randomized Controlled Trial
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class
    • Other: Standard of Care
  • No Intervention: Standard of Care
    All patients will receive currently practiced standard of care medicines
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 16, 2020
Actual Primary Completion Date September 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04512027
Other Study ID Numbers  ICMJE CIMED - 002- 2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Composite Interceptive Med Science
Study Sponsor  ICMJE Composite Interceptive Med Science
Collaborators  ICMJE Pharmalectin Inc
Investigators  ICMJE Not Provided
PRS Account Composite Interceptive Med Science
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP