EVALUATION OF CELLULAR IMMUNITY IN SARS-CoV-2 RECOVERED AND/OR VACCINATED SUBJECTS TO SARS-CoV-2 B-1.1.529 (OMICRON) VARIANT BY A SIMPLE CELLULAR IMMUNITY TEST
- Registration Number
- CTRI/2022/02/039925
- Lead Sponsor
- Atrimed Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Both male and female adult populations aged from 18 to 60 years with or without background co-morbidities 2)Convalescent, Rapid antigen test (RAT) negative for SARS-CoV2, IgG positive or negative, vaccinated for SARS CoV2 3) Unexposed, Rapid antigen test (RAT) negative for SARS-CoV2, IgG positive or negative, vaccinated either with COVAXIN or COVISHIELD for SARS CoV2 4) Volunteer is willing and able to comply with all the trial requirements 5) All volunteers obtained written informed consent form in English as well as native language, Kannada
1) Patients with active COVID-19 infection (RAT positive)
2) Known patients of HIV, Hepatitis-B/C, H1N1
3) Pregnant and lactating women
4) Patients with known autoimmune diseases on immunosuppressants and steroids
5) Patients who have participated in another clinical trial within the previous 30 days
6) Patient not willing to give informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of who has protective immunity against OMICRON variant of SARS-CoV-2 irrespective of IgG and vaccine status.Timepoint: Within 1 week of negative COVID19 rapid antigen test
- Secondary Outcome Measures
Name Time Method It will enable prioritised vaccination of susceptible populationTimepoint: Within 1 week of negative COVID19 rapid antigen test