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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04700358
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Ability to give consent
* Normal vital signs including:
* Blood pressure systolic value 150 - 100 mmHg, diastolic value \< 90 mmHg
* Respiratory rate \< 20/min
* Oxygen saturation \>92%
* Heart rate 50 - 110/min
* Body temperature \<38°C
Exclusion Criteria:
* Cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, Hemoglobin \< 12 g/dl)
* Heart disease or pulmonary hypertension
* Body weight \<50 kg (exclusion of blood sampling for B cell isolation)
* Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
* Any decline of the general state of health in the last 3 month including weight loss \> 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 \< 50%)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04700358
Study Brief:
Protocol Section:
NCT04700358