Tableted COVID-19 Therapeutic Vaccine (COVID-19)

• ClinicalTrials.gov Identifier: NCT04380532
• Recruitment Status: Unknown
• First Posted: May 8, 2020
• Last Update Posted: May 27, 2020
• Sponsor: Immunitor LLC
• Collaborator: Immunitor Inc.
• Information provided by (Responsible Party): Immunitor LLC

Tracking Information

• First Submitted Date: April 29, 2020
• First Posted Date: May 8, 2020
• Last Update Posted Date: May 27, 2020
• Actual Study Start Date: May 15, 2020
• Estimated Primary Completion Date: May 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tableted COVID-19 Therapeutic Vaccine
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Healthy volunteers

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Covid19

Intervention

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

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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 6, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 15, 2021
• Estimated Primary Completion Date: May 15, 2021 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Mongolia

Administrative Information

• NCT Number: NCT04380532
• Other Study ID Numbers: 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

• 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: Immunitor LLC
• Original Study Sponsor: Same as current
• Collaborators: Immunitor Inc.

Investigators

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

• PRS Account: Immunitor LLC
• Verification Date: May 2020