COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62582

Amitabha Sengupta

drasengupta@gmail.com

2021-11-10

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

i. Adults of either sex with laboratory confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) <br/ > 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 <93% at admission <br/ >

i. Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization <br/ > ii. History of or known current thrombosis <br/ > iii. Have a personal or first-degree family history of blood clotting disorders. <br/ > iv. Participants who are immunocompromised, with known immunodeficiencies <br/ > v. Participants with any malignancy <br/ > vi. Severe hepatic impairment, defined as Child-Pugh class C. <br/ > vii. Severe anemia (hemoglobin <8 g/dL). <br/ > viii. Absolute lymphocyte count <500 cells/mm, <br/ > ix. Absolute neutrophil count <1000 cells/mm. <br/ > x. Known allergy to Tofacitinib. <br/ > xi. Other medical or psychiatric condition <br/ > xii. Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) <br/ > 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. <br/ > 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. <br/ > xv. Current participation in other trials <br/ >

2

Institute of Postgraduate Medical Education and Research

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

60

Proportion of subjects alive at day 14.Timepoint: Day 14

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

Phase 2/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"}]