Aged patients at risk of COVID-19 infection MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Imatinib
Product Name: Imatinib
Pharmaceutical Form: Tablet
Sponsors
CH de Versailles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prevention of SARS-Cov 2 infection. EHPAD (nursing home) will be selected for the study in case of the diagnosis of at least one resident with a documented SRAS-Cov 2 infection or a suspected COVID-19 (Fever = 38°C and/or cough, thoracic pain or dyspnea) within the last 14 days. 1.Resident living is an open nurse home 2.Resident without symptom of COVID-19 3.No imatinib contra-indication 4.Signed informed consent Prevention of severe COVID-19 1.Patient aged > 70y 2.Patient with a documented SRAS-Cov 2 infection (if no test is available, suspected SARS-Cov 2 infection). 3.Initial phase (7 days) of COVID-19 4.Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 382
Exclusion criteria
Exclusion criteria: 1.Patient in palliative care 2.Contra-indication to imatinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 days;Secondary Objective: A.To evaluate the feasibility of imatinib therapy. B.To evaluate safety of matinbib therapy C.To evaluate mortality by 60 and 90 days D.To evaluate viral load (ancillary study) ;Main Objective: Prevention of SARS-CoV-2 infection. To evaluate the benefit of imatinib mesylate to prevent the SRAS-Cov 2 contamination in nursing home residents. Prevention of severe COVID-19 disease. To evaluate the benefit of early imatinib to prevent severe COVID-19 disease in hospitalized aged patients. ;Primary end point(s): Prevention of SARS-CoV-2 infection. To evaluate the benefit of imatinib mesylate to prevent the SRAS-Cov 2 contamination in nursing home residents. Prevention of severe COVID-19 disease. To evaluate the benefit of early imatinib to prevent severe COVID-19 disease in hospitalized aged patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A.To evaluate the faisability of imatinib mesylate therapy B.To evaluate the safety of imatinib mesylate therapy C.To evaluate the death rate at 90 days and overall survival D.To evaluate viral load (ancillary) ;Timepoint(s) of evaluation of this end point: 90 days | — |
Countries
France
Contacts
Public ContactMorisset laure
Ch de Versailles
Outcome results
None listed