T cell test for CoVID immunity
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/07/034670
- Lead Sponsor
- Yenepoya University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 15 ml/min
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical course of the disease, recovery , mortalityTimepoint: 2 weeks after blood draw
- Secondary Outcome Measures
Name Time Method Requirement for ICU care, organ failureTimepoint: 2 weeks after blood draw