Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04357613
Status:
UNKNOWN
Last Update Posted:
2020-08-07
First Post:
2020-04-20
Brief Title:
IMATINIB IN COVID-19 DISEASE IN AGED PATIENTS
Sponsor:
Versailles Hospital
Organization:
Versailles Hospital
Study Overview
Official Title:
A RANDOMIZED NON-COMPARATIVE PHASE 2 PILOT STUDY TESTING THE VALUE OF IMATINIB MESYLATE AS AN EARLY TREATMENT OF COVID-19 DISEASE IN AGED HOSPITALIZED PATIENTS
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGE-19
Brief Summary:
High-throughput screening studies identified Abl kinase inhibitors including imatinib as inhibitors of coronaviruses SARS and MERS The SARS-CoV-2 coronavirus depend on Abl2 kinase activity to fuse and enter into the cells Pharmacokinetic studies demonstrated that IC50 of imatinib for ABL1 BCR-ABL1 and ABL2 kinase inhibition is less than 1 microM around 03 microM below the expected trough plasmatic concentrations of imatinib 400 mgday 17 microM The EC50 of imatinib for the inhibition of the virus is under investigation but we now have a first estimates with EC50 close to 25 microM This plasmatic concentration is achievable with imatinib 800 mgd We hypothesize that clinically achievable imatinib concentration will block the first round of cell to cell virus infection and therefore stop or prevent from SARS-CoV-2 infection in human Based on our 20 years experience of prescribing imatinib in patients we expect that most of the adverse events and pharmacological interactions of imatinib can be anticipated and corrected The eligible population will be aged 70y patients hospitalized for a non-severe COVID-19 disease for less than 7 days Patients will be randomized 11 between standard of care and imatinib 800 mg per day during 14 days The primary endpoint will be the death rate by 30 days Secondary endpoint will include progression to severe CIVID-19 disease safety outcome at 3 months We plan to randomize 90 patients in order to show a 10 benefit in term of death rate reduction from 16 to 6
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None