Tableted COVID-19 Therapeutic Vaccine

NCT04380532 | Unknown Phase 1

• 1 other identifier: Imm24
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Covid19

Keywords

COVID-19; SARS-CoV-2; coronavirus; respiratory disease; SARS; ARDS; pneumonia; pandemic

Outcome Measures

Primary Outcomes (2)

• 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

  15 Days

• 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

  15 Days

Secondary Outcomes (1)

• Lack of adverse events as per CTCAE v4.0

  15 days

Study Arms (1)

V-SARS recipients

EXPERIMENTAL

Single arm having at least 20 volunteers administered once-per-day pill of V-SARS

Biological: V-SARS

Interventions

V-SARS BIOLOGICAL

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

V-SARS recipients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Immunitor LLC: lead
• Immunitor Inc.: collaborator

Study Sites (2)

Immunitor Inc

Vancouver, BC - British Columbia, V6K 2G8, Canada

Location

Aldar Bourinbayar

Ulaanbaatar, BZD, 3-khoroo, 13381, Mongolia

Location

Related Publications (1)

• 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.

  PMID: 17683247 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Respiration Disorders; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aldar Bourinbayar, MD/PhD

  Immunitor LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy volunteers

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 8, 2020
• Study Start: May 15, 2020
• Primary Completion: May 15, 2021
• Study Completion: June 15, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: when become public
• Access Criteria: non-confidential data

Locations

MO (1); CA (1)