Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tablet Tofacitinib 10 mg BID: Tablet Tofacitinib 10 mg BID on top of Standard Care for 10 days.
Comparator is Standard Care alone, no placebo Intervention – Tablet. Tofacitinib 10
Control – Current standard of care as per AIIMS and Government of Karnataka’s protocol.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
St Johns Medical College Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality up to 28 days of follow-up in the intervention versus control group.Timepoint: 28 days from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Deepak Kamath
St Johns Medical College Hospital
Outcome results
None listed