IMATINIB IN COVID-19 DISEASE IN AGED PATIENTS.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-01

Brief Summary

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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%.

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Detailed Description

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Conditions

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SARS Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expérimental ARM

800mg/d IMATINIB during 14days

Group Type EXPERIMENTAL

Experimental drug

Intervention Type DRUG

Imatinib 800mg/d during 14days

Comparator ARM

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental drug

Imatinib 800mg/d during 14days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No