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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT05403359
Eligibility Criteria:
Inclusion Criteria:
To be eligible for inclusion in any of the work packages, an individual must meet all of the following general inclusion criteria:
1. Adult (i.e., ≥18 years)
2. Hospitalized (i.e., admitted to the hospital)
3. Laboratory-confirmed COVID-19 diagnosis (i.e., based on polymerase chain reaction-(PCR) test)
WP1A- ward early:
(1) Patients who present with WHO clinical progression scale class 4-5 (no oxygen therapy, Figure 5) when admitted to the ward with COVID-19.
WP1B-ward late:
1. Admitted to the ward (e.g., pulmonology ward, COVID-unit, etc.), excluding step-down units.
2. In need of non-invasive oxygen therapy during hospital stay, including:
* Conventional oxygen therapy (COT) 1-5 L/min
* Conventional oxygen therapy (COT) 6-12 L/min
* Non-rebreather mask 12-15 L/min
* High-flow nasal cannula 16-60 L/min
* Non-invasive continuous positive airway pressure (CPAP)
* Non-invasive bilevel positive airway pressure (BiPAP)
WP2-ICU admission/ WP3-ICU late:
1. Admitted to the ICU\>48 hours.\*
2. Invasive mechanical ventilation during ICU stay (intubation with endotracheal tube or tracheostomy) or extracorporeal membrane oxygenation (ECMO).
3. ARDS according to the Berlin criteria
WP4-biobank:
The study population consists of patient subsets admitted to the ICU described in WP2 and WP3.
Exclusion Criteria:
General exclusion criteria:
* Mortality within 48 hours.\*
* Opt-out (objection to participate)
Criteria indicated with an asterisk (\*) may or may not be applied, depending on data availability. These criteria will be instated if they result in excessive variation of the outcome or exposure, or result in difficulty in generalizing to the target population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05403359
Study Brief:
Protocol Section:
NCT05403359