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Evaluation of efficacy of Tofacitinib in COVID 19 patients - A prospective randomised study

Effect of Tofacitinib added to standard therapy on ICU stay in critically ill patients with COVID 19 infection - A prospective randomized control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038732
Enrollment
80
Registered
2021-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Tofacitinib: Tofacitinib 10 mg BD PO for 14days Control Intervention1: NIL: NIL

Sponsors

Bangalore Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. SARS Co V2 positivity to the nasal swab by RTPCR 2. Presence of radiological findings of pneumonia assessed by chest radiography and HRCT 3. Patients with eGFR 15-30 ml/min 4. PaO2/ FiO2 100-300 mmHg at ABG

Exclusion criteria

Exclusion criteria: 1. Patients with active / latent tuberculosis 2. Patients with pre - existing AKI, EGFR 3. Patients with deranged liver function test 4. Patients with history of chronic dialysis and renal transplant 5. Patients with history of thrombophlebitis and acute / chronic autoimmune disorder 6. Patients with serology positive 7. Patients on immunosuppressive drugs 8. Pregnant and lactation

Design outcomes

Primary

MeasureTime frame
1. Incidence and duration of non-invasive ventilation/ high flow oxygen 2. Incidence and duration of invasive mechanical ventilation 3. Frequency of adverse kidney events 4. Number of days in ICU 5. ICU mortality 6. Hospital mortalityTimepoint: NEWS score baseline, and at 1week, 2 weeks

Secondary

MeasureTime frame
Frequency of adverse kidney eventsTimepoint: at 1 week and 2 weeks

Countries

India

Contacts

Public ContactDr Vijay Kumar H N

Bangalore Medical College and Research Institute

viji2751977@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026