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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05130320
Eligibility Criteria:
Inclusion criteria:
1. Age ≥ 16 years
2. For asthma patients:
1. Diagnosis of severe asthma (based on ATS/ERS consensus criteria)
2. Group A: Currently receiving an asthma biologic with treatment having started at least 3 months before first COVID-19 vaccine
3. Group B: on maintenance oral steroids at a dose of ≥5mg prednisolone (or equivalent) per day (at the time of first COVID-19 vaccine)
4. Group C: not on asthma biologic or maintenance oral steroids (at the time of vaccination) or stopped ≥3 months prior to first COVID-19 vaccine
Exclusion criteria:
1. Current pregnancy or planning a pregnancy within the next 6 months
2. Current malignancy
3. Diagnosis of immunodeficiency requiring treatment
4. Additional exclusion criteria for asthma patients:
1. Group A: maintenance oral steroids at the time of first COVID-19 vaccine
2. Group B: on an asthma biologic at the time of first COVID-19 vaccine
5. Additional exclusion criteria for healthy controls cohort (as assessed by research team):
1. No history of asthma or significant other lung disease
2. Severe chronic inflammatory disease
3. Severe cardiac disease
4. Diabetes
6. Previous proven COVID-19 infection
7. Inability to provide informed consent
8. Unwilling to have vaccination
9. Participation in another clinical trial involving an investigational medicinal product (IMP).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
100 Years
Study:
NCT05130320
Study Brief:
Protocol Section:
NCT05130320