Covid19
Conditions
Keywords
COVID-19, SARS-CoV-2, coronavirus, respiratory disease, SARS, ARDS, pneumonia, pandemic
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.
Interventions
BIOLOGICALV-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
Sponsors
Immunitor Inc.
Immunitor LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Healthy volunteers
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lack of adverse events as per CTCAE v4.0 | 15 days | Clinical well-being assessed by CTCAE v4.0 |
Countries
Canada, Mongolia
Outcome results
None listed