Imatinib in COVID-19 infectio
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/04/024806
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a)Age -18 years and above (no upper age limit )
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) <=3
Exclusion Criteria
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.
b)Abnormal renal functions at baseline, i.e.. Serum creatinine > 1.5 ULN
c)Prior history of exposure to imatinib
d)Any other condition assessed by physiciansâ?? team that will lead to difficulty in carrying out the trial.
e)Pregnant or breast feeding women.
f)Patients unable to swallow oral medicines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-7 <br/ ><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
- Secondary Outcome Measures
Name Time Method Docking studies for the drug will be done during the course of study.Timepoint: during the course of whole study;i)To investigate improvement in symptoms at D-3,D-7, D-10 & D-14 <br/ ><br>ii)To study duration of hospitalization, mechanical ventilation or death by day 28. <br/ ><br>iii)Safety analysis as per CTCAE version 5.0 <br/ ><br>Timepoint: Day -14 and Day-28