NCT04380532

Tableted COVID-19 Therapeutic Vaccine

Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Immunitor LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-15
• Primary completion: 2021-05-15
• Completion: 2021-06-15
• First posted: 2020-05-08
• Last updated: 2020-05-27

Locations

2 sites across 2 countries: Canada, Mongolia