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临床试验/CTRI/2021/07/034670
CTRI/2021/07/034670尚未招募未知

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

Yenepoya University0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 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

排除标准

  • 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

研究者

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