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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357613
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Philippe ROUSSELOT, Versailles Hospital

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 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%.

Condition or disease Intervention/treatment Phase
SARS Virus Drug: Experimental drug Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Expérimental ARM
800mg/d IMATINIB during 14days
Drug: Experimental drug
Imatinib 800mg/d during 14days

No Intervention: Comparator ARM
Standard of care



Primary Outcome Measures :
  1. To evaluate the benefit of early imatinib therapy to prevent severe COVID-19 disease in hospitalized aged patients. [ Time Frame: 30 days ]
    To evaluate the 30 days mortality rate in aged patients hospitalized with COVID-19


Secondary Outcome Measures :
  1. To evaluate the feasibility of imatinib therapy. [ Time Frame: Day 14 ]
    Drop out rate of imatinib mesylate therapy

  2. To evaluate safety of imatinib therapy [ Time Frame: 3 months ]
    Adverse events related to imatinib mesylate therapy

  3. To evaluate the clinical evolution [ Time Frame: 3 months ]
    Clinical (WHO COVID scale) and geriatric scores (GIR, ADL and IADL) modification

  4. To evaluate the progression rate to severe COVID-19 disease [ Time Frame: 3 months ]
    Clinical (WHO COVID scale) and geriatric scores (GIR, ADL and IADL) modification

  5. To evaluate mortality [ Time Frame: 14 days ]
    number of death

  6. To evaluate mortality [ Time Frame: 60 days ]
    number of death

  7. To evaluate mortality [ Time Frame: 90 days ]
    number of death

  8. To evaluate viral load [ Time Frame: 14 days ]
    Viral load by SARS-CoV-2 PCR

  9. To evaluate plasmatic levels of imatinib [ Time Frame: 14 days ]
    Imatinib trough level



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357613


Contacts
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Contact: Laure Morisset +33139239785 lmorisset@ch-versailles.fr

Locations
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France
CHU Bordeaux
Bordeaux, France
Contact: Malvy         
CH de Versailles
Le Chesnay, France
Contact: Philippe Rousselot         
Sponsors and Collaborators
Versailles Hospital
Investigators
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Principal Investigator: Philippe Rousselot CH Versailles
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Responsible Party: Philippe ROUSSELOT, MD, Versailles Hospital
ClinicalTrials.gov Identifier: NCT04357613    
Other Study ID Numbers: P20/05_IMAGE19
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No