COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=63071

Dr Vijay Kumar H N

viji2751977@gmail.com

2021-12-20

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

1. Patients with active / latent tuberculosis <br/ > 2. Patients with pre - existing AKI, EGFR < 15ml/min <br/ > 3. Patients with deranged liver function test <br/ > 4. Patients with history of chronic dialysis and renal transplant <br/ > 5. Patients with history of thrombophlebitis and acute / chronic autoimmune disorder <br/ > 6. Patients with serology positive <br/ > 7. Patients on immunosuppressive drugs <br/ > 8. Pregnant and lactation

2

Bangalore Medical College and Research Institute

18

90

India

Severe disease at enrollment

6: Severe disease at enrollment

80

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

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

Not reported

[{"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"}]