Long-Term Outcomes After ICU-Treated COVID-19 ARDS

NCT07397156 | Completed

• 1 other identifier: KB 03/165/2021
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cohort study describes long-term survival and patient-reported health after intensive care unit (ICU) treatment for COVID-19-related acute respiratory distress syndrome (ARDS) in adults treated in a single center in Poland. The main questions it aims to answer are:

1. 1.What is all-cause mortality up to 4 years after ICU admission for COVID-19-related ARDS?
2. 2.Among long-term survivors, what are the health-related quality of life and functional outcomes approximately 4 years after ICU admission?
3. 3.What rehabilitation use, return-to-work outcomes, and self-reported financial burden are reported during follow-up, and which acute-phase clinical and laboratory factors are associated with late mortality and long-term outcomes?

Conditions

COVID-19; ARDS (Acute Respiratory Distress Syndrome)

Keywords

intensive care unit; ICU survivors; long-term outcomes; 4-year follow-up; health-related quality of life; EQ-5D-5L; modified Medical Research Council (mMRC); Post-COVID-19 Functional Status (PCFS); rehabilitation; return to work; financial burden

Outcome Measures

Primary Outcomes (2)

• All-Cause Mortality at 30 Days

  Proportion of participants who died from any cause within 30 days of ICU admission.

  30 days after ICU admission

• All-Cause Mortality up to 4 Years

  Proportion of participants who died from any cause from ICU admission through 4 years after ICU admission (cumulative mortality).

  From ICU admission up to 4 years after ICU admission

Secondary Outcomes (9)

• Late All-Cause Mortality Among 30-Day Survivors

  Day 31 through 4 years after ICU admission

• Health-Related Quality of Life (EQ-5D-5L Index Value)

  Approximately 4 years after ICU admission (single telephone follow-up assessment)

• Self-Rated Health (EQ Visual Analogue Scale [EQ-VAS])

  Approximately 4 years after ICU admission (single telephone follow-up assessment)

• Functional Status (Post-COVID-19 Functional Status [PCFS] Grade)

  Approximately 4 years after ICU admission (single telephone follow-up assessment)

• Breathlessness Severity (modified Medical Research Council [mMRC] Score)

  Approximately 4 years after ICU admission (single telephone follow-up assessment)

Study Arms (1)

ICU-Treated COVID-19 ARDS Cohort

Consecutive adult patients treated in the intensive care unit (ICU) for COVID-19-related acute respiratory distress syndrome (ARDS) at a single center in Poland, admitted between December 2020 and July 2021. This was an observational study with no assigned experimental intervention. Long-term vital status was assessed up to approximately 4 years after ICU admission; survivors were invited to a structured telephone follow-up to assess patient-reported outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) treated in a single intensive care unit in Poland for COVID-19-related acute respiratory distress syndrome (ARDS) requiring invasive mechanical ventilation during the pandemic surge (December 2020-July 2021). Long-term survival was assessed for the full cohort up to approximately 4 years after ICU admission, and survivors were invited to a structured telephone follow-up to assess patient-reported outcomes.

You may qualify if:

• Baseline cohort (retrospective ICU cohort)
• Adults (≥18 years) admitted to the Temporary Hospital in Zielona Góra ICU between December 2020 and July 2021
• Confirmed SARS-CoV-2 infection
• COVID-19-related acute respiratory distress syndrome (ARDS)
• Required invasive mechanical ventilation during ICU treatment
• Prospective follow-up component (telephone interview):
• Confirmed alive at approximately 4 years after ICU admission
• Agreed to participate in a structured telephone interview (voluntary participation)

You may not qualify if:

• Baseline cohort:
• Prospective follow-up component (telephone interview):
• Declined participation in the telephone interview
• Unable to be reached after repeated contact attempts (non-responder)

Sponsors & Collaborators

• University in Zielona Góra: lead

Study Sites (1)

University in Zielona Góra

Zielona Góra, Lubusz Voivodeship, Poland

Location

MeSH Terms

Conditions

COVID-19; Acute Lung Injury; Financial Stress

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: April 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 13, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

PL (1)