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T cell test for CoVID immunity

Development of an ex-vivo assay of SARS COV-2 specific T-cell responses using an interferon gamma assay

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034670
Enrollment
300
Registered
2021-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

Yenepoya University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Above 18 years of age 2.Recent SARS COV-2 infection (recovered or active) detected by rapid antigen test or real time reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 3.Primary contact of a SARS COV-2 patient diagnosed as above 4.Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion criteria

Exclusion criteria: 1. Below 18 years of age 2. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses 3. Obstructive pneumonia induced by lung cancer or other known causes 4. Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer. 5. History of long-term use of immunosuppressive agents including prednisone dose >5mg daily over the 30 days prior to enrollment. 6. History of severe chronic respiratory disease and requirement for long-term oxygen therapy 7. Undergoing hemodialysis or peritoneal dialysis 8. Estimated or actual rate of creatinine clearance 9. History of moderate and severe liver disease (Child-Pugh score >12) 10. History of substance abuse sufficient that the patient is unlikely to comply with testing requirements. 11. History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years 12. Known HIV, hepatitis virus, or syphilis infection 13. Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus 14. Moribund patient not expected to survive > 24hours 15. Any condition unsuitable for the study as determined by the investigators 16. Female subjects with a positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. 17. Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study. 18. Previous or ongoing immune deficient states â?? active malignancy , undergoing chemotherapy or radiotherapy, active secondary sepsis, post-transplant , patients with immunological/ rheumatologic disorders, active HIV infection

Design outcomes

Primary

MeasureTime frame
Clinical course of the disease, recovery , mortalityTimepoint: 2 weeks after blood draw

Secondary

MeasureTime frame
Requirement for ICU care, organ failureTimepoint: 2 weeks after blood draw

Countries

India

Contacts

Public ContactSonal Asthana

Yantra Health Pvt Ltd

sonal@transplantationliver.com9686976379

Outcome results

None listed

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