severe acute respiratory syndrome coronavirus 2(SARS-CoV 2)
Conditions
Interventions
Trade Name: Imatinib Teva 400 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB
CAS Number: 152459-95-5
Other descriptive name: IMATINIB
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Positive SARS-CoV-2 test on nasopharyngeal swab ? Onset of symptoms =65 years) yes F.1.3.1 Number of subjects for this age range 1057
Exclusion criteria
Exclusion criteria: ? Inability to make a decision to participate (dementia, guardianship) ? Long QT syndrome, or QTc space > 500 ms ? Heart rate 5.5 mmol/L or hypokalemia < 3.5 mmol/L ? Treatment with dasatinib, nilotinib, ibrutinib, , potent inhibitors of cytochrome P450 CYP3A4 isoenzyme, potent inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin. ? Hypersensitivity to any of the trial drugs, , ARA2 or sartan. ? Liver failure (stage = Child-Pugh B), stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²), person on dialysis, malabsorption syndrome, symptomatic gout/hyperuricemia, ileus, colitis or enterocolitis, chronic infection with the hepatitis B virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is To estimate the efficacy of several specific experimental treatments, compared to standard care, to prevent hospitalization or death at D14 in adults over 65 years of age, with documented SARS-CoV-2 infection, with symptoms lasting less than 72 hours and not meeting any hospitalization criteria.;Secondary Objective: To estimate : - the effectiveness of experimental treatments against SARS-CoV-2, to prevent death on D28 - the effectiveness of experimental treatments against SARS-CoV-2, to prevent hospitalization on D28 - the effectiveness of experimental treatments against SARS-CoV-2, compared to standard care, to prevent hospitalization in intensive care on D28 - the effectiveness of experimental treatments against SARS-CoV-2 to suppress nasopharyngeal viral carriage, compared to standard care - the effectiveness of experimental treatments against SARS-CoV-2, compared to standard care, to prevent a loss of autonomy on D14 and D28 - the tolerance of experimental treatments against SARS-CoV-2 - Study the factors associated with the worsening of the disease - Evaluate the feasibility and acceptability of the trial and the care model implemented - Assess the relationship between the concentration of each drug and the effectiveness of each treatment;Primary end point(s): Proportion of participants with an occurrence of hospitalization and/or death between D0 and D14 in each arm;Timepoint(s) of evaluation of this end point: day 14 after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The analyzes on the secondary endpoints, with the exception of the toxicity results, will be carried out with the intention of treating on the available data;Timepoint(s) of evaluation of this end point: day 28 after inclusion | — |
Countries
France
Contacts
Public ContactREC
CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC
Outcome results
None listed