Tableted COVID-19 Therapeutic Vaccine (COVID-19)

May 22, 2020 updated by: Immunitor LLC

Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill

Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • BC - British Columbia
      • Vancouver, BC - British Columbia, Canada, V6K 2G8
        • Immunitor Inc
  • Mongolia
    • BZD, 3-khoroo
      • Ulaanbaatar, BZD, 3-khoroo, Mongolia, 13381
        • Aldar Bourinbayar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
  • Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)

Exclusion Criteria:

  • Unable to take oral medication,
  • Immunocompromised
  • Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
  • BMI less than 18
  • Smoking history (more than one pack per day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V-SARS recipients
Single arm having at least 20 volunteers administered once-per-day pill of V-SARS
Biological: V-SARS
Therapeutic vaccine formulated as a pill derived from heat-inactivated plasma from COVID-19 patients administered once-per-day to at least 20 healthy volunters for at least one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on CBC as per CTCAE v4.0
Time Frame: 15 Days
Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods
15 Days
Effect on biochemistry parameters as per CTCAE v4.0
Time Frame: 15 Days
Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
15 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lack of adverse events as per CTCAE v4.0
Time Frame: 15 days
Clinical well-being assessed by CTCAE v4.0
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunitor LLC

Collaborators

Immunitor Inc.

Investigators

  • Principal Investigator: Aldar Bourinbayar, MD/PhD, Immunitor LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

June 15, 2021

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Imm24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Free dissemination of published data

IPD Sharing Time Frame

when become public

IPD Sharing Access Criteria

non-confidential data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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