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Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support. (Prolectin-M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
COVID-19 Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

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
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



Primary Outcome Measures :
  1. SarsCoV2 viral copy number [ Time Frame: 7 days from randomisation ]
    Change in absolute viral copy number


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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India
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, India, 560099
Sponsors and Collaborators
Composite Interceptive Med Science
Pharmalectin Inc
Publications:
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Responsible Party: Composite Interceptive Med Science
ClinicalTrials.gov Identifier: NCT04512027    
Other Study ID Numbers: CIMED - 002- 2020
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Composite Interceptive Med Science:
ddPCR,
SarsCoV2 Copies