Tableted COVID-19 Therapeutic Vaccine

Immunitor

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Covid19

Treatments

Biological: V-SARS

Study type

Interventional

Funder types

Industry

Identifiers

NCT04380532

Imm24

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)