IMATINIB IN COVID-19 DISEASE IN AGED PATIENTS. (IMAGE-19)

V

Versailles Hospital

Status and phase

Unknown
Phase 2

Conditions

SARS Virus

Treatments

Drug: Experimental drug

Study type

Interventional

Funder types

Other

Identifiers

NCT04357613
P20/05_IMAGE19

Details and patient eligibility

About

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 0.3 microM) below the expected trough plasmatic concentrations of imatinib 400 mg/day (1.7 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 2.5 microM. This plasmatic concentration is achievable with imatinib 800 mg/d. 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 1/1 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%.

Enrollment

99 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:. Patient aged > 70y 2. Patient with a documented COVID-19 disease by SARS-CoV-2 RT-PCR (if no test is available, suspected COVID-19 disease on CT SCAN).

3. Initial phase (≤ 7 days) of COVID-19 disease 4. Non severe COVID-19 disease 5. Signed informe consent

Exclusion Criteria:

  • Patient in palliative care
  • Severe COVID-19 disease (SpO2 ≤ 94% with O2 ≥ 5 l/min)
  • Contra-indication to imatinib
  • Therapy with Warfarin (Heparin allowed)
  • Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA)
  • Peripheral edema grade > 2
  • Known HBV, HBC or HIV infection
  • Known hepatic failure
  • Patient under legal protection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

99 participants in 2 patient groups

Expérimental ARM
Experimental group
Description:
800mg/d IMATINIB during 14days
Treatment:
Drug: Experimental drug
Comparator ARM
No Intervention group
Description:
Standard of care

Trial contacts and locations

0

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Central trial contact

Laure Morisset

Data sourced from clinicaltrials.gov

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