| CTRI Number |
CTRI/2020/04/024806 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Imatinib in COVID-19 infection |
|
Scientific Title of Study
|
Efficacy of Imatinib in mild SARS CoV2 infection: A randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Medical Oncology,
2nd Floor, BRAIRCH,
All India Institute Of Medical Sciences,
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akash Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Medical Oncology,
2nd Floor, BRAIRCH,
All India Institute Of Medical Sciences,
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Medical Oncology,
2nd Floor, BRAIRCH,
All India Institute Of Medical Sciences,
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akash Kumar |
All India Institute of Medical Sciences |
Department of Medical Oncology, 2nd Floor, BRA IRCH, AIIMS
South
DELHI |
9910850134
akashjha08@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
| AIIMS Instituet Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Imatinib - Oral Drug |
Imatinib- 600mg per oral once daily
(D1-D14) |
| Comparator Agent |
supportive care |
supportive care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 physicians’ team that will lead to difficulty in carrying out the trial.
e) Pregnant or breast feeding women.
f) Patients unable to swallow oral medicines.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-7
2. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-14 |
d-7 & d-14 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
i) To investigate improvement in symptoms at D-3,D-7, D-10 & D-14
ii) To study duration of hospitalization, mechanical ventilation or death by day 28.
iii) Safety analysis as per CTCAE version 5.0
|
Day -14 and Day-28 |
| Docking studies for the drug will be done during the course of study. |
during the course of whole study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COVID -19 is a respiratory illness that has led to a anaemic affecting more that 200 countries in the world. It si caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has s significant genomic homology to SARS and MERS viruses. Due to sudden advent and rapid spread of infection, no antiviral drug has been found to be effective since onset. In view of requirement of long time period to develop a targeted anti-viral, there is a need of repurposing already available drugs, that have in-vitro anti-viral activity. Imatinib is one such drug which has inhibitory activity in early phases of SARS and MERS corona virus infection, studied in-vitro. We hypothesize that imatinib by inhibiting ABL kinases, can have inhibitory activity in SARSCoV2 infection. |