Tableted COVID-19 Therapeutic Vaccine

Covid19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04380532
• Other study ID #: Imm24
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 15, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: May 2020
• Source: Immunitor LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Canada	Immunitor Inc	Vancouver	BC - British Columbia
Mongolia	Aldar Bourinbayar	Ulaanbaatar	BZD, 3-khoroo

Sponsors (2)

Lead Sponsor	Collaborator
Immunitor LLC	Immunitor Inc.

Countries where clinical trial is conducted

Canada,  Mongolia, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Lack of adverse events as per CTCAE v4.0	Clinical well-being assessed by CTCAE v4.0	15 days