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

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class

Standard of Care

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring ddPCR,, SarsCoV2 Copies

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mazumdar Shaw Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care

Standard of Care

Arm Description

Tablet chewed for 5 days along and given alongside standard of care

All patients will receive currently practiced standard of care medicines

Outcomes

Primary Outcome Measures

SarsCoV2 viral copy number

Change in absolute viral copy number

Secondary Outcome Measures

b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.

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); Death

Full Information

NCT ID

NCT04512027

First Posted

August 11, 2020

Last Updated

October 16, 2020

Sponsor

Composite Interceptive Med Science

Collaborators

Bioxytran Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04512027

Brief Title

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

Acronym

Prolectin-M

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

September 15, 2020 (Actual)

Primary Completion Date

September 19, 2020 (Actual)

Study Completion Date

October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Composite Interceptive Med Science

Collaborators

Bioxytran Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

ddPCR,, SarsCoV2 Copies

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care

Arm Type

Experimental

Arm Description

Tablet chewed for 5 days along and given alongside standard of care

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

All patients will receive currently practiced standard of care medicines

Intervention Type

Other

Intervention Name(s)

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class

Intervention Description

A treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.

Primary Outcome Measure Information:

Title

SarsCoV2 viral copy number

Description

Change in absolute viral copy number

Time Frame

7 days from randomisation

Secondary Outcome Measure Information:

Title

b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.

Description

Time Frame

28 days from randomisation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Mazumdar Shaw Medical Centre

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560099

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32438868

Citation

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.

Results Reference

background

Citation

http://medrxiv.org/lookup/doi/10.1101/2020.02.29.20029439

Results Reference

background

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

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