COVID-19 MedDRA version: 20.0 Level: LLT Classification code 10038700 Term: Respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: itraconazole
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ITRACONAZOLE
CAS Number: 84625-61-6
Product Name: itraconazole
Pharmaceutical Form: Oral solution
INN or Proposed IN
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject (=18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness not related to the investigational research study will be obtained. 2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. Male or non-pregnant female adult =18 years of age at time of enrolment. 4. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization. 5. Illness of any duration, and at least one of the following: a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or b. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, or c. Requiring mechanical ventilation and/or supplemental oxygen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. ALT/AST > 5 times the upper limit of normal. 2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 3. Pregnancy or breast feeding. 4. Allergy to any study medication 5. Any medical condition which would impose an unacceptable safety hazard by participation to the study. 6. Study drug specific exclusion criteria: - for itraconazole: heart failure , concomitant treatment with lopinavir/ritonavir, and potent CYP450 inducers such as rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the standard of care in patients hospitalized with COVID-19.;Secondary Objective: To evaluate clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by Clinical Severity, Oxygenation, Ventilation, Hospitalisation.;Primary end point(s): Clinical status of subject at day 15 (on a 7-point ordinal scale): 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.;Timepoint(s) of evaluation of this end point: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical Severity Oxygenation: Mechanical Ventilation: Hospitalization Mortality Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm ;Timepoint(s) of evaluation of this end point: Day 15 and day 29 | — |
Countries
Belgium
Contacts
Public ContactLaurens Liesenborghs
UZ Leuven
Outcome results
None listed