COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001243-15/BE

UZ Leuven - Laurens Liesenborghs

laurens.liesenborghs@uzleuven.be

2020-03-27

Terminated

RCT

Randomized

Adaptive

Open label

single-center

Treatment

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.

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.

2

UZLeuven

18

None

Belgium

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

200

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.

nan

Phase 2

[{"arm_notes": "unclear two arms", "treatment_id": 692, "treatment_name": "Itraconazole", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]