Critical IllnessCOVID19 LTFUNCT04360538
Long Term Outcomes of Patients With COVID-19
An observational study of Critical Illness and Corona Virus Infection, run by University of Chicago at 1 site in United States.
Trial summary
The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Corona Virus Infection, Respiratory Failure
- What is being tested?
- Quality of Life, Impact Event Score and Hospital anxiety and depression scale
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2020to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: adult patients admitted to the intensive care unit
Who may be able to join
- adult patients admitted to the ICU
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.
Read the detailed description
The aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of COVID-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. These outcomes of interest will be evaluated prospectively. The investigators will perform these measures in Covid-19 patients with respiratory failure and compare them to non-Covid-19 patients with respiratory failure. The investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. Finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.
- Being tested
- Quality of Life, Impact Event Score, Hospital anxiety and depression scale
- Keywords
- long term outcomes, mechanical ventilation, noninvasive ventilation
- Medical subject headings
- Critical Illness, Coronavirus Infections, Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of LifeOther
Also called SF-36
Physical disability assessment tool
Impact Event ScoreOther
Also called IES-R
Psychological Sequelae assessment tool
Hospital anxiety and depression scaleOther
Psychological Sequelae assessment tool
| Study group | Role | What they receive |
|---|---|---|
| COVID19 positive | ICU patients coronavirus positive Receives: Other: Quality of Life; Other: Impact Event Score; Other: Hospital anxiety and depression scale | |
| non-COVID19 | ICU patients without coronavirus Receives: Other: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life score
SF-36 score
Measured: up to 12 months after discharge
Secondary outcomes (4)
cognitive dysfunction
Montreal Cognitive Assessment (MoCA) score
Measured: up to 12 months after discharge
Functional Status Score
(FSS-ICU)
Measured: up to 12 months after discharge
Physical Disability
MRC neuromuscular Assessment
Measured: up to 12 months after discharge
Psychological Sequelae
Impact Event Score
Measured: up to 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 Apr 2020
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360538
- Sponsor's protocol ID
- 20-0538
- Acronym
- COVID19 LTFU
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2020
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04360538
- Acronym / sponsor ID
- COVID19 LTFU / 20-0538
- Keywords
- long term outcomes, mechanical ventilation, noninvasive ventilation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 24 Apr 2020 (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.
The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.
Detailed description
The aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of COVID-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. These outcomes of interest will be evaluated prospectively. The investigators will perform these measures in Covid-19 patients with respiratory failure and compare them to non-Covid-19 patients with respiratory failure. The investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. Finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19 positive | – | Other: Quality of Life, Other: Impact Event Score, Other: Hospital anxiety and depression scaleICU patients coronavirus positive |
| non-COVID19 | – | Other: Quality of LifeICU patients without coronavirus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients admitted to the intensive care unit
Key inclusion criteria (1 listed)
- adult patients admitted to the ICU
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of LifeAlso: SF-36Physical disability assessment tool | Other | COVID19 positive, non-COVID19 |
| Impact Event ScoreAlso: IES-RPsychological Sequelae assessment tool | Other | COVID19 positive |
| Hospital anxiety and depression scalePsychological Sequelae assessment tool | Other | COVID19 positive |
Primary outcome
Quality of Life score
Time frame: up to 12 months after discharge
SF-36 score
4 secondary outcomes
cognitive dysfunction
Time frame: up to 12 months after discharge
Functional Status Score
Time frame: up to 12 months after discharge
Physical Disability
Time frame: up to 12 months after discharge
Psychological Sequelae
Time frame: up to 12 months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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 Critical Illness and Corona Virus Infection, run by University of Chicago at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of Life score (time frame: up to 12 months after discharge). 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 13 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.