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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

Evaluation of cellular immunity in SARS-CoV-2recovered and/or vaccinated subjects to SARS-CoV-2 B-1.1.529 (OMICRON) variant by a simple Cellular Immunity Test (SCIT)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/02/039925
Enrollment
75
Registered
2022-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Control Intervention1: NIL: NIL

Sponsors

Atrimed Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
It will enable prioritised vaccination of susceptible populationTimepoint: Within 1 week of negative COVID19 rapid antigen test

Countries

India

Contacts

Public ContactDr Hrishikesh Damle

Immunitas Biosciences Pvt. Ltd.

shiv@immunitasbio.com9632469944

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026