COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42843

Akash Kumar

akashjha08@yahoo.com

2020-04-22

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

a) Age -18 years and above (no upper age limit ) <br/ >b) Mildly symptomatic Patients admitted in the AIIMS hospital with a proven diagnosis of COVID 19 infection on RT-PCR, with National Early Warning Score (NEWS score) â?¤3 <br/ >

a) Abnormal Liver function at baseline, i.e. Serum Bilirubin > 1.5 ULN, ALT and AST > 3 ULN. Upto 5 times in case of chronic liver disease. <br/ >b) Abnormal renal functions at baseline, i.e.. Serum creatinine > 1.5 ULN <br/ >c) Prior history of exposure to imatinib <br/ >d) Any other condition assessed by physiciansâ?? team that will lead to difficulty in carrying out the trial. <br/ >e) Pregnant or breast feeding women. <br/ >f) Patients unable to swallow oral medicines. <br/ >

2

All India Institute of Medical Sciences

18

None

India

Mild disease at enrollment

1: Mild disease at enrollment

100

1. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-7 <br/ >2. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-14Timepoint: d-7 & d-14

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

Phase 2

[{"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "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"}]