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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT04536350
Eligibility Criteria:
Inclusion Criteria:
* COVID-19 infection diagnosed
* Risk factors for the development of an ARDS according to an adapted EALI (early acute lung injury score) ≥ 2 Points (with at least one point from the EALI score)
EALI Score:
* 2-6l O2 supplementation to achieve a SaO2\>90%: 1 point
* \>6l O2 supplementation to achieve a SaO2\>90%: 2 points
* Respiratory rate ≥ 30/min: 1 point
* Immunosuppression: 1 Point
Modification (for adapting for risk factors for ARDS in SARS-CoV-2 affected patients
* Arterial hypertension: 1 point
* Diabetes: 1 point
* Fever \> 39°C: 1 point
* Age \> 18 years
* Ability to adequate compliance with the inhalation manoeuvre
* Ability to sign the informed consent
Exclusion Criteria:
* Known or highly suspected bacterial infection (antibiotic treatment to avoid bacterial superinfection may be allowed)
* PCT ≥ 1μg/l
* Mechanical ventilation
* Inability to conduct inhalation therapy
* Hemodynamic instability with requirement of vasopressor therapy
* Severe comorbidities interfering with the safe participation at the trial according to the treating physician
* Pregnancy
* Systemic immunosuppression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04536350
Study Brief:
Protocol Section:
NCT04536350