COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56057

Dr Deepak Kamath

vineeta.s@stjohns.in

2021-06-10

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1. Signs and symptoms consistent with COVID-19 <br/ >infection confirmed with rapid antigen test (RAT) <br/ >or RT- PCR. <br/ >2. Hospitalised with moderate or severe COVID-19 <br/ >illness

1. COVID-19 like illness, not confirmed by RAT/ RTPCR. <br/ >2. Prior treatment with any of Jakinibs for any <br/ >indication. <br/ >3. Past treatment with any of the following biologics - <br/ >TNF(i), tocilizumab(in the last 3 months). <br/ >4. e-GFR < 30 ml/hr at screening. <br/ >5. Pre-existing lung disease requiring home oxygen <br/ >therapy. <br/ >6. Malignancies on conventional chemotherapeutic <br/ >regimens or targeted treatments. <br/ >7. Post- transplant with ongoing immunosuppressive <br/ >therapy, <br/ >8. HIV/AIDS <br/ >9. Pregnancy <br/ >10. Critically ill patients in ICU <br/ >11. Coexisting septic shock, and/or multiple organ <br/ >dysfunction <br/ >12. Anticipated death within next 24 hours as per

2

St Johns Medical College Hospital

18

99

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

409

All-cause mortality up to 28 days of follow-up in the intervention versus control <br/ >group.Timepoint: 28 days from randomization

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1300, "treatment_name": "Tofacitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]