COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001614-38/BE

UZ Leuven - clinical trial center UZ Leuven

ctc@uzleuven.be

2020-04-06

Terminated

RCT

Randomized

Adaptive

Open label

multi-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 a confirmed diagnosis of SARS-CoV-2 infection within 72 hours prior to randomization, defined as either: a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen or b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses 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. Pregnancy or breast feeding. 3. Allergy to any study medication 4. Any medical condition which would impose an unacceptable safety hazard by participation to the study. 5. Study drug specific exclusion criteria: *for Azithromycin : o heart failure with severely reduced ejection fraction (30%) o known prolonged long QT interval on ECG (> 470 msec males and > 480 females with Fridericia criteria, for patients with ventricular conduction delay the use of Rautaharju formula is also allowed ) o patients on Macrolides during the last week before admission *For other treatment strata, see arm-specific protocols.

2

UZLeuven

18

None

Belgium

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

282

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. Primary outcome will be time from Day 0 to sustained clinical improvement or life discharge, whichever comes first, whereby a sustained clinical improvement is defined as an improvement of ≥ 2 points vs the highest value of Day 0 and 1 and sustained for at least 3 days.

Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]