IMATINIB IN COVID-19 DISEASE IN AGED PATIENTS. (IMAGE-19)
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ClinicalTrials.gov Identifier: NCT04357613 |
Recruitment Status : Unknown
Verified August 2020 by Philippe ROUSSELOT, Versailles Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : August 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS Virus | Drug: Experimental drug | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Expérimental ARM
800mg/d IMATINIB during 14days
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Drug: Experimental drug
Imatinib 800mg/d during 14days |
No Intervention: Comparator ARM
Standard of care
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- 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
- To evaluate the feasibility of imatinib therapy. [ Time Frame: Day 14 ]Drop out rate of imatinib mesylate therapy
- To evaluate safety of imatinib therapy [ Time Frame: 3 months ]Adverse events related to imatinib mesylate therapy
- To evaluate the clinical evolution [ Time Frame: 3 months ]Clinical (WHO COVID scale) and geriatric scores (GIR, ADL and IADL) modification
- 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
- To evaluate mortality [ Time Frame: 14 days ]number of death
- To evaluate mortality [ Time Frame: 60 days ]number of death
- To evaluate mortality [ Time Frame: 90 days ]number of death
- To evaluate viral load [ Time Frame: 14 days ]Viral load by SARS-CoV-2 PCR
- 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 |
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

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
Contact: Laure Morisset | +33139239785 | lmorisset@ch-versailles.fr |
France | |
CHU Bordeaux | |
Bordeaux, France | |
Contact: Malvy | |
CH de Versailles | |
Le Chesnay, France | |
Contact: Philippe Rousselot |
Principal Investigator: | Philippe Rousselot | CH Versailles |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |