Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT04398004
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Male of female gender
* Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent
* In case of women, unwillingness to remain pregnant during the study period achieved either by their partner using condom or by themselves using oral contraceptives.
* Confirmed infection by SARS-CoV-2 virus
* Infection of the upper respiratory tract or of the lower respiratory tract
Exclusion Criteria:
* Age below 18 years
* Denial of written informed consent
* Intake of any macrolide for the current episode of infection under study
* Intake of hydroxychloroquine or chloroquine phosphate.
* Presence of severe respiratory failure
* Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 15 days
* Neutropenia defined as an absolute neutrophil count below 1,000/mm3
* Presence of any contraindications for the study drugs as stated in local label information
* QTc interval at rest electrocardiogram ≥500 msec or history of known congenital long QT syndrome
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04398004
Study Brief:
Protocol Section:
NCT04398004