Tableted COVID-19 Therapeutic Vaccine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: V-SARS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-SARS recipients<br>Single arm having at least 20 volunteers administered once-per-day pill of V-SARS | Biological: V-SARS<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lack of adverse events as per CTCAE v4.0 | Clinical well-being assessed by CTCAE v4.0 | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pandemic, COVID-19, SARS-CoV-2, coronavirus, respiratory disease, SARS, ARDS, pneumonia