Evaluation of use and right time identification to initiate Tofacitinib use in the treatment of moderate- severe COVID-19 infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/034162
- Lead Sponsor
- St Johns Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
1. Signs and symptoms consistent with COVID-19
infection confirmed with rapid antigen test (RAT)
or RT- PCR.
2. Hospitalised with moderate or severe COVID-19
illness
1. COVID-19 like illness, not confirmed by RAT/ RTPCR.
2. Prior treatment with any of Jakinibs for any
indication.
3. Past treatment with any of the following biologics -
TNF(i), tocilizumab(in the last 3 months).
4. e-GFR < 30 ml/hr at screening.
5. Pre-existing lung disease requiring home oxygen
therapy.
6. Malignancies on conventional chemotherapeutic
regimens or targeted treatments.
7. Post- transplant with ongoing immunosuppressive
therapy,
8. HIV/AIDS
9. Pregnancy
10. Critically ill patients in ICU
11. Coexisting septic shock, and/or multiple organ
dysfunction
12. Anticipated death within next 24 hours as per
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality up to 28 days of follow-up in the intervention versus control <br/ ><br>group.Timepoint: 28 days from randomization
- Secondary Outcome Measures
Name Time Method To evaluate the effects of Tofacitinib 10 mg BD administered for 10 days (on top of standard care) compared to standard careTimepoint: 28 days from randomization