SARS VirusPhase 2IMAGE-19NCT04357613
IMATINIB IN COVID-19 DISEASE IN AGED PATIENTS.
A Phase 2 study testing Experimental drug in people with SARS Virus, run by Versailles Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- SARS Virus
- What is being tested?
- Experimental drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2020to 1 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Known HBV, HBC or HIV infection
- Known hepatic failure
- Patient under legal protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Bordeaux
Bordeaux
Malvy
CH de Versailles
Le Chesnay
Philippe Rousselot
About this study
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.
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%.
- Conditions
- SARS Virus
- Being tested
- Experimental drug
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drugDrug
Imatinib 800mg/d during 14days
| Study group | Role | What they receive |
|---|---|---|
| Expérimental ARM | Experimental | 800mg/d IMATINIB during 14days Receives: Drug: Experimental drug |
| Comparator ARM | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the benefit of early imatinib therapy to prevent severe COVID-19 disease in hospitalized aged patients.
To evaluate the 30 days mortality rate in aged patients hospitalized with COVID-19
Measured: 30 days
Secondary outcomes (9)
To evaluate the feasibility of imatinib therapy.
Drop out rate of imatinib mesylate therapy
Measured: Day 14
To evaluate safety of imatinib therapy
Adverse events related to imatinib mesylate therapy
Measured: 3 months
To evaluate the clinical evolution
Clinical (WHO COVID scale) and geriatric scores (GIR, ADL and IADL) modification
Measured: 3 months
To evaluate the progression rate to severe COVID-19 disease
Clinical (WHO COVID scale) and geriatric scores (GIR, ADL and IADL) modification
Measured: 3 months
To evaluate mortality
number of death
Measured: 14 days
To evaluate mortality
number of death
Measured: 60 days
To evaluate mortality
number of death
Measured: 90 days
To evaluate viral load
Viral load by SARS-CoV-2 PCR
Measured: 14 days
To evaluate plasmatic levels of imatinib
Imatinib trough level
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe ROUSSELOT, Versailles Hospital
- Investigators
- Philippe Rousselot, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357613
- Sponsor's protocol ID
- P20/05_IMAGE19
- Acronym
- IMAGE-19
- Status last verified
- Aug 2020
- First submitted
- 20 Apr 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao H, Mendenhall M, Deininger MW. Imatinib is not a potent anti-SARS-CoV-2 drug. Leukemia. 2020 Nov;34(11):3085-3087. doi: 10.1038/s41375-020-01045-9. Epub 2020 Sep 30. No abstract available.
PubMed 32999432
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04357613
- Acronym / sponsor ID
- IMAGE-19 / P20/05_IMAGE19
- Conditions
- SARS Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expérimental ARM | Experimental | Drug: Experimental drug800mg/d IMATINIB during 14days |
| Comparator ARM | No intervention | –Standard of care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental drugImatinib 800mg/d during 14days | Drug | Expérimental ARM |
Primary outcome
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
9 secondary outcomes
To evaluate the feasibility of imatinib therapy.
Time frame: Day 14
To evaluate safety of imatinib therapy
Time frame: 3 months
To evaluate the clinical evolution
Time frame: 3 months
To evaluate the progression rate to severe COVID-19 disease
Time frame: 3 months
To evaluate mortality
Time frame: 14 days
To evaluate mortality
Time frame: 60 days
To evaluate mortality
Time frame: 90 days
To evaluate viral load
Time frame: 14 days
To evaluate plasmatic levels of imatinib
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 32999432Zhao H, Mendenhall M, Deininger MW. Imatinib is not a potent anti-SARS-CoV-2 drug. Leukemia. 2020 Nov;34(11):3085-3087. doi: 10.1038/s41375-020-01045-9. Epub 2020 Sep 30. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Rousselot principal investigator
CH Versailles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental drug in people with SARS Virus, run by Versailles Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure Morisset (+33139239785, lmorisset@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the benefit of early imatinib therapy to prevent severe COVID-19 disease in hospitalized aged patients. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.