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A simple test for COVID-19 immunity

Evaluation of Cellular Immunity in SARS-CoV-2 recovered subjects as an alternative to IgG testing - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030796
Enrollment
60
Registered
2021-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Control Intervention1: NIL: NIL

Sponsors

Atrimed Biotech LLP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Both male and female adult populations aged from 18 to 60 years with background comorbidities such as Type II Diabetes mellitus(DM), hypertension(HTN), Bronchial asthma, Ischemic heart disease(IHD), cerebrovascular accidents(CVA), Thyroid disorders will be included in the study. 2) Convalescent, RTPCR negative for SARS-CoV2 ( 2 weeks), IgG positive for SARS CoV2 , asymptomatic patients as determined by the principal investigator/ physician. 3) SARS CoV2 frontline workers are included as test subjects. 4) Non health care workers are included as control subjects. 5) 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( PCR positive, IgM positive). 2) Known patients of HIV, Hepatitis-B/C , H1N1. 3) Pregnant and lactating women. 4) Patients with known autoimmune diseases on immuno-suppressants and steroids. 5) Patients who have participated in another clinical trial within the previous 30 days. 6) Patient not willing to give informed consent form

Design outcomes

Primary

MeasureTime frame
COVID-19 T-cell immunity positive or negativeTimepoint: within 1 week of COVID-19 negative PCR test or 3 weeks after COVID-19 active infection

Secondary

MeasureTime frame
Indicator of COVID-19 T-cell immunity in recovered patients and for vaccine efficiencyTimepoint: 4weeks post infection

Countries

India

Contacts

Public ContactDr Hrishikesh Damle

Indoor Biotechnologies India Pvt. Ltd.

shiv_shankar@hotmail.com9632469944

Outcome results

None listed

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