Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tofacitinib: Tofacitinib 5mg BD for 14 days with standard of care
Control Intervention1: Standard of care: Standard of care
Sponsors
Institute of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: i. Adults of either sex with laboratory confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) ii. Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND hypoxia defined as room air saturation of
Exclusion criteria
Exclusion criteria: i. Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization ii. History of or known current thrombosis iii. Have a personal or first-degree family history of blood clotting disorders. iv. Participants who are immunocompromised, with known immunodeficiencies v. Participants with any malignancy vi. Severe hepatic impairment, defined as Child-Pugh class C. vii. Severe anemia (hemoglobin viii. Absolute lymphocyte count ix. Absolute neutrophil count x. Known allergy to Tofacitinib. xi. Other medical or psychiatric condition xii. Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) xiii. Have received any of these within 4 weeks prior to the first dose of study intervention: any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (e.g., Tocilizumab) or IL-1 inhibitors (e.g., anakinra) within the past 30 days; any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer. xiv. Have received treatment with corticosteroids equivalent to prednisone or methylprednisolone >20 mg/day for equal or more than 14 consecutive days prior to screening. xv. Current participation in other trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects alive at day 14.Timepoint: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects on supplemental oxygen but not needing any form of mechanical ventilation, or ECMO by day 14. 2. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 3. Not hospitalized and not requiring home oxygen at day 14 4. Number of days in hospital 5. Number of days in ICU 6. Number of patients who went on to require mechanical ventilation after admission. Timepoint: Day 14 | — |
Countries
India
Contacts
Public ContactAmitabha Sengupta
Institute of Postgraduate Medical Education and Research
Outcome results
None listed