Tableted COVID-19 Therapeutic Vaccine

Phase 1

• Conditions: Covid19

• Registration Number: NCT04380532
• Lead Sponsor: Immunitor LLC

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 Timeline

• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-08
• Study Start: 2020-05-15
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27
• Primary Completion: 2021-05-15
• Study Completion: 2021-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effect on biochemistry parameters as per CTCAE v4.0	15 Days	Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Effect on CBC as per CTCAE v4.0	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

Secondary Outcome Measures

Name	Time	Method
Lack of adverse events as per CTCAE v4.0	15 days	Clinical well-being assessed by CTCAE v4.0

Trial Locations

Locations (2)

Immunitor Inc; 🇨🇦 Vancouver, BC - British Columbia, Canada

Aldar Bourinbayar; 🇲🇳 Ulaanbaatar, BZD, 3-khoroo, Mongolia