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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

Tracking Information
First Submitted Date  ICMJE April 29, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE May 15, 2020
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
Lack of adverse events as per CTCAE v4.0 [ Time Frame: 15 days ]
Clinical well-being assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tableted COVID-19 Therapeutic Vaccine
Official Title  ICMJE Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Healthy volunteers
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: V-SARS recipients
Single arm having at least 20 volunteers administered once-per-day pill of V-SARS
Intervention: Biological: V-SARS
Publications * Silin DS, Lyubomska OV, Jirathitikal V, Bourinbaiar AS. Oral vaccination: where we are? Expert Opin Drug Deliv. 2007 Jul;4(4):323-40. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 6, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Mongolia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04380532
Other Study ID Numbers  ICMJE Imm24
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Immunitor LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Immunitor LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Immunitor Inc.
Investigators  ICMJE
Principal Investigator: Aldar Bourinbayar, MD/PhD Immunitor LLC
PRS Account Immunitor LLC
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP