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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05225194
Eligibility Criteria:
COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19
Inclusion Criteria:
* Age ≥18 years;
* Hospitalization due to COVID-19;
* Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
* Diagnosis of ARDS during hospitalization according to the Berlin definition;
* Expected to survive and be discharged directly home from the hospital.
Exclusion Criteria:
* Severe comorbidity with life expectancy less than 3 months;
* Unavailability to attend the study follow-up appointment;
* Death during hospitalization;
* Absence of proxy for patients with communication difficulties;
* Refusal or withdrawal of agreement to participate.
COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19
Inclusion Criteria:
* Age ≥18 years;
* Hospitalization;
* Diagnosis of ARDS during hospitalization according to the Berlin definition;
* Expected to survive and be discharged directly home from the hospital.
Exclusion Criteria:
* Severe comorbidity with life expectancy less than 3 months;
* Unavailability to attend the study follow-up appointment;
* Death during hospitalization;
* History of SARS-CoV-2 infection within the last 12 months;
* Absence of proxy for patients with communication difficulties;
* Refusal or withdrawal of agreement to participate.
FAMILY CONTROLS
Inclusion Criteria:
* Age ≥18 years;
* Family member of a enrolled participant (either from the COVID-19 ARDS cohort or from the non-COVID-19 ARDS cohort)
Exclusion Criteria:
* Severe comorbidity with life expectancy less than 3 months;
* Unavailability to attend the study follow-up appointment;
* History of SARS-CoV-2 infection within the last 12 months;
* History of non-elective hospitalization due to medical condition within the last 12 months;
* Refusal or withdrawal of agreement to participate.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05225194
Study Brief:
Protocol Section:
NCT05225194