COVID-19NCT07397156
Long-Term Outcomes After ICU-Treated COVID-19 ARDS
An observational study of COVID-19 and ARDS (Acute Respiratory Distress Syndrome), run by University in Zielona Góra at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, ARDS (Acute Respiratory Distress Syndrome)
- How many people
- 283 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2025to 13 Aug 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Baseline cohort:
- None (no additional clinical exclusion criteria)
- Prospective follow-up component (telephone interview):
- Declined participation in the telephone interview
- Unable to be reached after repeated contact attempts (non-responder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 4-Year Mortality, Functional Outcomes, and Quality of Life After ICU-Treated COVID-19-Related ARDS: A Retrospective-Prospective Cohort Study
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:
- What is all-cause mortality up to 4 years after ICU admission for COVID-19-related ARDS?
- Among long-term survivors, what are the health-related quality of life and functional outcomes approximately 4 years after ICU admission?
- 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?
Participants did not receive any experimental intervention as part of this study. The study team collected clinical information from hospital and ICU records and conducted a structured telephone follow-up with survivors using standardized questionnaires (including EQ-5D-5L for quality of life, the modified Medical Research Council [mMRC] scale for breathlessness, and the Post-COVID-19 Functional Status [PCFS] scale for functional status), as well as questions about rehabilitation and work status.
Read the detailed description
This is an observational retrospective-prospective cohort study of adults treated in the intensive care unit (ICU) for COVID-19-related acute respiratory distress syndrome (ARDS) at a single center in Poland (University Hospital in Zielona Góra / Temporary COVID-19 Hospital in Zielona Góra). The cohort includes consecutive eligible ICU admissions between December 2020 and July 2021. No experimental intervention was assigned as part of this study.
Acute-phase clinical data were obtained from routinely collected hospital and ICU documentation. These data include baseline demographics, pre-existing comorbidities, severity of illness, and organ dysfunction at ICU admission, selected laboratory and physiological parameters, and key aspects of ICU management and clinical course. Long-term vital status was assessed for approximately 4 years after ICU admission, using available clinical records and follow-up procedures described in the protocol.
A structured telephone follow-up was conducted approximately 4 years after ICU admission among long-term survivors to collect patient-reported outcomes using standardized instruments and a predefined interview script. The follow-up assessment captured health-related quality of life, breathlessness, and functional status, and also included questions on post-discharge rehabilitation, return-to-work status, and self-reported financial burden related to recovery.
Analyses are descriptive and exploratory. Mortality over time is described using time-to-event methods, and associations between selected acute-phase variables and late mortality and long-term patient-reported outcomes are evaluated using multivariable models, with appropriate handling of missing data and sensitivity analyses as specified in the statistical analysis plan. The study was conducted with approval from the relevant ethics committee, and participant consent procedures for the follow-up interview were implemented in accordance with local requirements.
Time perspective: Retrospective extraction of acute-phase ICU data (December 2020-July 2021) with a single structured telephone follow-up of survivors approximately 4 years after ICU admission.
- 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
- Medical subject headings
- COVID-19, Acute Lung Injury, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality at 30 Days
Proportion of participants who died from any cause within 30 days of ICU admission.
Measured: 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).
Measured: From ICU admission up to 4 years after ICU admission
Secondary outcomes (9)
Late All-Cause Mortality Among 30-Day Survivors
Proportion of participants who died from any cause between day 31 and 4 years after ICU admission, among participants alive at day 30.
Measured: Day 31 through 4 years after ICU admission
Health-Related Quality of Life (EQ-5D-5L Index Value)
EQ-5D-5L health utility index value derived from the EQ-5D-5L questionnaire administered during structured telephone follow-up.
Measured: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Self-Rated Health (EQ Visual Analogue Scale [EQ-VAS])
Q-VAS score collected as part of the EQ-5D-5L questionnaire during structured telephone follow-up (among survivors who completed follow-up).
Measured: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Functional Status (Post-COVID-19 Functional Status [PCFS] Grade)
Functional status assessed using the PCFS scale (grade), collected during structured telephone follow-up.
Measured: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Breathlessness Severity (modified Medical Research Council [mMRC] Score)
Breathlessness assessed using the modified Medical Research Council (mMRC) dyspnea scale; reported as mMRC score collected during structured telephone follow-up (among survivors who completed follow-up).
Measured: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Subjective Cognitive Complaints (Two Screening Items Adapted From the Cognitive Failures Questionnaire [CFQ])
Presence and/or severity of subjective cognitive complaints assessed using two screening items adapted from the Cognitive Failures Questionnaire (CFQ) during structured telephone follow-up (among survivors who completed follow-up).
Measured: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Sleep Disturbance (Single Screening Item)
Self-reported sleep disturbance assessed using a brief single screening item during structured telephone follow-up (among survivors who completed follow-up).
Measured: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Time to Return to Work
Self-reported time to return to work after the index hospitalization, collected during structured telephone follow-up (among survivors who were working prior to critical illness and completed follow-up).
Measured: Assessed at approximately 4 years after ICU admission (recall of post-discharge period)
Post-Discharge Rehabilitation Exposure and Duration
Self-reported participation in rehabilitation after hospital discharge and total rehabilitation duration (e.g., weeks), collected during structured telephone follow-up (among survivors who completed follow-up).
Measured: Assessed at approximately 4 years after ICU admission (recall of post-discharge period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Apr 2025
- Primary completion1 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 283 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University in Zielona Góra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Zawadzki, University in Zielona Góra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397156
- Sponsor's protocol ID
- KB 03/165/2021
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data (IPD) has not been finalized. Any future sharing would require additional ethics and data protection review and would be considered only in a de-identified form under a data use agreement. Aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-Year Mortality, Functional Outcomes, and Quality of Life After ICU-Treated COVID-19-Related ARDS: A Retrospective-Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07397156
- Acronym / sponsor ID
- KB 03/165/2021
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University in Zielona GóraUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is all-cause mortality up to 4 years after ICU admission for COVID-19-related ARDS?
- Among long-term survivors, what are the health-related quality of life and functional outcomes approximately 4 years after ICU admission?
- 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?
Participants did not receive any experimental intervention as part of this study. The study team collected clinical information from hospital and ICU records and conducted a structured telephone follow-up with survivors using standardized questionnaires (including EQ-5D-5L for quality of life, the modified Medical Research Council [mMRC] scale for breathlessness, and the Post-COVID-19 Functional Status [PCFS] scale for functional status), as well as questions about rehabilitation and work status.
Detailed description
This is an observational retrospective-prospective cohort study of adults treated in the intensive care unit (ICU) for COVID-19-related acute respiratory distress syndrome (ARDS) at a single center in Poland (University Hospital in Zielona Góra / Temporary COVID-19 Hospital in Zielona Góra). The cohort includes consecutive eligible ICU admissions between December 2020 and July 2021. No experimental intervention was assigned as part of this study.
Acute-phase clinical data were obtained from routinely collected hospital and ICU documentation. These data include baseline demographics, pre-existing comorbidities, severity of illness, and organ dysfunction at ICU admission, selected laboratory and physiological parameters, and key aspects of ICU management and clinical course. Long-term vital status was assessed for approximately 4 years after ICU admission, using available clinical records and follow-up procedures described in the protocol.
A structured telephone follow-up was conducted approximately 4 years after ICU admission among long-term survivors to collect patient-reported outcomes using standardized instruments and a predefined interview script. The follow-up assessment captured health-related quality of life, breathlessness, and functional status, and also included questions on post-discharge rehabilitation, return-to-work status, and self-reported financial burden related to recovery.
Analyses are descriptive and exploratory. Mortality over time is described using time-to-event methods, and associations between selected acute-phase variables and late mortality and long-term patient-reported outcomes are evaluated using multivariable models, with appropriate handling of missing data and sensitivity analyses as specified in the statistical analysis plan. The study was conducted with approval from the relevant ethics committee, and participant consent procedures for the follow-up interview were implemented in accordance with local requirements.
Time perspective: Retrospective extraction of acute-phase ICU data (December 2020-July 2021) with a single structured telephone follow-up of survivors approximately 4 years after ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- None (no additional clinical exclusion criteria)
- Declined participation in the telephone interview
- Unable to be reached after repeated contact attempts (non-responder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-Cause Mortality at 30 Days
Time frame: 30 days after ICU admission
Proportion of participants who died from any cause within 30 days of ICU admission.
All-Cause Mortality up to 4 Years
Time frame: From ICU admission up to 4 years after ICU admission
Proportion of participants who died from any cause from ICU admission through 4 years after ICU admission (cumulative mortality).
9 secondary outcomes
Late All-Cause Mortality Among 30-Day Survivors
Time frame: Day 31 through 4 years after ICU admission
Health-Related Quality of Life (EQ-5D-5L Index Value)
Time frame: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Self-Rated Health (EQ Visual Analogue Scale [EQ-VAS])
Time frame: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Functional Status (Post-COVID-19 Functional Status [PCFS] Grade)
Time frame: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Breathlessness Severity (modified Medical Research Council [mMRC] Score)
Time frame: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Subjective Cognitive Complaints (Two Screening Items Adapted From the Cognitive Failures Questionnaire [CFQ])
Time frame: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Sleep Disturbance (Single Screening Item)
Time frame: Approximately 4 years after ICU admission (single telephone follow-up assessment)
Time to Return to Work
Time frame: Assessed at approximately 4 years after ICU admission (recall of post-discharge period)
Post-Discharge Rehabilitation Exposure and Duration
Time frame: Assessed at approximately 4 years after ICU admission (recall of post-discharge period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data (IPD) has not been finalized. Any future sharing would require additional ethics and data protection review and would be considered only in a de-identified form under a data use agreement. Aggregated results will be reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and ARDS (Acute Respiratory Distress Syndrome), run by University in Zielona Góra at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality at 30 Days (time frame: 30 days after ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.