Tableted COVID-19 Therapeutic Vaccine (COVID-19)
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
V-SARS
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, SARS-CoV-2, coronavirus, respiratory disease, SARS, ARDS, pneumonia, pandemic
Eligibility Criteria
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)
Sites / Locations
- Immunitor Inc
- Aldar Bourinbayar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
V-SARS recipients
Arm Description
Single arm having at least 20 volunteers administered once-per-day pill of V-SARS
Outcomes
Primary Outcome Measures
Effect on CBC as per CTCAE v4.0
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
Effect on biochemistry parameters as per CTCAE v4.0
Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Secondary Outcome Measures
Lack of adverse events as per CTCAE v4.0
Clinical well-being assessed by CTCAE v4.0
Full Information
NCT ID
NCT04380532
First Posted
April 29, 2020
Last Updated
May 22, 2020
Sponsor
Immunitor LLC
Collaborators
Immunitor Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04380532
Brief Title
Tableted COVID-19 Therapeutic Vaccine
Acronym
COVID-19
Official Title
Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitor LLC
Collaborators
Immunitor Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, SARS-CoV-2, coronavirus, respiratory disease, SARS, ARDS, pneumonia, pandemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Healthy volunteers
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V-SARS recipients
Arm Type
Experimental
Arm Description
Single arm having at least 20 volunteers administered once-per-day pill of V-SARS
Intervention Type
Biological
Intervention Name(s)
V-SARS
Intervention Description
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
Primary Outcome Measure Information:
Title
Effect on CBC as per CTCAE v4.0
Description
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
Time Frame
15 Days
Title
Effect on biochemistry parameters as per CTCAE v4.0
Description
Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Time Frame
15 Days
Secondary Outcome Measure Information:
Title
Lack of adverse events as per CTCAE v4.0
Description
Clinical well-being assessed by CTCAE v4.0
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldar Bourinbayar, MD/PhD
Organizational Affiliation
Immunitor LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Immunitor Inc
City
Vancouver
State/Province
BC - British Columbia
ZIP/Postal Code
V6K 2G8
Country
Canada
Facility Name
Aldar Bourinbayar
City
Ulaanbaatar
State/Province
BZD, 3-khoroo
ZIP/Postal Code
13381
Country
Mongolia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Free dissemination of published data
IPD Sharing Time Frame
when become public
IPD Sharing Access Criteria
non-confidential data
IPD Sharing URL
http://immunitor.com
Citations:
PubMed Identifier
17683247
Citation
Silin DS, Lyubomska OV, Jirathitikal V, Bourinbaiar AS. Oral vaccination: where we are? Expert Opin Drug Deliv. 2007 Jul;4(4):323-40. doi: 10.1517/17425247.4.4.323.
Results Reference
background
Learn more about this trial
Tableted COVID-19 Therapeutic Vaccine
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