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Tableted COVID-19 Therapeutic Vaccine (COVID-19)

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: NCT04380532
Recruitment Status : Unknown
Verified May 2020 by Immunitor LLC.
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Immunitor Inc.
Information provided by (Responsible Party):
Immunitor LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: V-SARS Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy volunteers
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Lack of adverse events as per CTCAE v4.0 [ Time Frame: 15 days ]
    Clinical well-being assessed by CTCAE v4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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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): NCT04380532


Locations
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Canada, BC - British Columbia
Immunitor Inc
Vancouver, BC - British Columbia, Canada, V6K 2G8
Mongolia
Aldar Bourinbayar
Ulaanbaatar, BZD, 3-khoroo, Mongolia, 13381
Sponsors and Collaborators
Immunitor LLC
Immunitor Inc.
Investigators
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Principal Investigator: Aldar Bourinbayar, MD/PhD Immunitor LLC
More Information
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Publications:

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Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT04380532    
Other Study ID Numbers: Imm24
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Free dissemination of published data
Supporting Materials: Study Protocol
Time Frame: when become public
Access Criteria: non-confidential data
URL: http://immunitor.com

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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 Immunitor LLC:
COVID-19
SARS-CoV-2
coronavirus
respiratory disease
 SARS
ARDS
pneumonia
pandemic
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases