Covid19LUNGTERMcovNCT04881266
Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors
An observational study of Covid19 and ARDS, run by University of Zurich at 1 site in Switzerland.
Trial summary
The corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, ARDS, Critical Illness
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 May 2021to 31 Dec 2023
- 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
- Adult, Older adult
Study population: The project population targeted with this research, consists of a post critically illness, COVID-19 diagnosed population having been admitted to one of the participating centers, as well as their closest caregiver. The closest caregiver is defined as the person spending most of the time with the patient and mainly responsible for the patients daily support and care (professional caregivers will not be included).
Who may be able to join
- Previous admission to one of the participating centers for COVID-19 critical illness treatment
- Previously proven SARS-CoV-2 infection
- Critical COVID-19 defined as respiratory failure and/ or shock and/ or multiorgan dysfunction or failure
- Signed Study Informed Consent
Who cannot join
- Age <18 years
- Rejection of the study
Trial locations and contacts
1 site in 1 country.
About this study
The corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical ventilation requirement and in some cases even mandating use of extra-corporeal membrane oxygenation. Being a disease having affected up to 15'581'009 as of July 25th, with more than 635'173 deaths, the long-term repercussions are of foremost importance. Health care systems world-wide will be faced with the aftermath of COVID-19, and optimal understanding of the long-term progression of COVID-19 may aid in a better care of critically ill patients and enable specifically targeted rehabilitation programs to improve outcomes.
Primary objective of this study is to assess the repercussions of COVID-19 induced critical illness on long-term functional status, quality-of-life, neuropsychology and cognition
Read the detailed description
Health-care systems are ever improving, organ-support is advancing towards un-thought of possibilities and critical care medicine is becoming a field of evidence. As a consequence critical illness is bridgeable in many cases and intensive care unit (ICU) and hospital outcomes account for excellent survival numbers. In contrast to intensivist believes for decades nevertheless, a patient's life is not restored to normality the moment ICU survival is achieved, the real crucible is but starting at that moment. Sequela after critical illness are manifold and impact the functional status, quality-of-life, neuropsychology as well as cognition of patients surviving, leading to higher incidences of co-morbidities and a shortened life-expectancy.
Specifically reflecting the complex interplay between acute respiratory distress syndrome and long-term outcomes, the last decade has seen a plethora of research elaborating on the long-term outcomes of patients having suffered acute respiratory distress syndrome. The serious functional limitations in patients post critical illness were mainly linked to muscle wasting and weakness, and only secondarily to lung function, neuropathies and other etiologies. Further, the impaired neuropsychological status, especially mediated by posttraumatic stress disorder, and cognitive status have a great impact on the reduced health status and quality-of-life. On the other hand nevertheless, pulmonary function was near normal after up-to 5 years of follow-up. Finally, the impact of acute respiratory distress syndrome (ARDS) and critical illness have on caregivers should not be forgotten, with high levels of depressive symptoms having been reported.
Similar sequela were also described during the severe acute respiratory syndrome (SARS) epidemic in 2003.
The corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical ventilation requirement and in some cases even mandating use of extra-corporeal membrane oxygenation. The median length of stay and of mechanical ventilation support in COVID-19 have been shown to be elevated in comparison to other ARDS etiologies. Being a disease having affected up to 92 million people during the year 2020, with more than 1.9 Million deaths reported, the long-term repercussions are of foremost importance. Health care systems world-wide will be faced with the aftermath of COVID-19, and optimal understanding of the long-term progression of COVID-19 may aid in a better care of critically ill patients and enable specifically targeted rehabilitation programs to improve outcomes.
The overall objective of this study is therefore to evaluate the long-term outcomes of COVID-19 induced critical illness regarding functional status, quality-of-life, neuropsychology and cognition.
- Conditions
- Covid19, ARDS, Critical Illness, Neurocognitive Dysfunction
- Medical subject headings
- COVID-19, Critical Illness, Cognition Disorders
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 |
|---|---|---|
| Post Critical Illness due to COVID-19 | Not described | |
| Caregivers of Post critically ill COVID-19 patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Function: FEV1
Development of pulmonary function over time post intensive care unit stay due to COVID-19
Measured: Mixed Model assessment of FEV1 over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19
Change in Quality of Life: SF-36 Score
Development of quality of life over time post intensive care unit stay due to COVID-19
Measured: Mixed Model assessment of SF-36 Score over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19
Change in Neuropsychological Status: RBANS Score
Development of Neuropsychological Status over time post intensive care unit stay due to COVID-19
Measured: Mixed Model assessment of RBANS Score over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19
Change in Quality of Life in Caregivers: SF-36 Score
Development of quality of life in Caregivers over time post intensive care unit stay due to COVID-19 of patients
Measured: Mixed Model assessment of SF-36 Score over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19 of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start7 May 2021 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto A Schuepbach, Prof. Dr., Principal investigator, Institute of Intensive Care Medicine, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881266
- Sponsor's protocol ID
- 2021-00209
- Acronym
- LUNGTERMcov
- Status last verified
- May 2021
- First submitted
- 3 Mar 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors
- ClinicalTrials.gov ID
- NCT04881266
- Acronym / sponsor ID
- LUNGTERMcov / 2021-00209
- Conditions
- Covid19, ARDS, Critical Illness, Neurocognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 7 May 2021 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 May 2021 (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 corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical ventilation requirement and in some cases even mandating use of extra-corporeal membrane oxygenation. Being a disease having affected up to 15'581'009 as of July 25th, with more than 635'173 deaths, the long-term repercussions are of foremost importance. Health care systems world-wide will be faced with the aftermath of COVID-19, and optimal understanding of the long-term progression of COVID-19 may aid in a better care of critically ill patients and enable specifically targeted rehabilitation programs to improve outcomes.
Primary objective of this study is to assess the repercussions of COVID-19 induced critical illness on long-term functional status, quality-of-life, neuropsychology and cognition
Detailed description
Health-care systems are ever improving, organ-support is advancing towards un-thought of possibilities and critical care medicine is becoming a field of evidence. As a consequence critical illness is bridgeable in many cases and intensive care unit (ICU) and hospital outcomes account for excellent survival numbers. In contrast to intensivist believes for decades nevertheless, a patient's life is not restored to normality the moment ICU survival is achieved, the real crucible is but starting at that moment. Sequela after critical illness are manifold and impact the functional status, quality-of-life, neuropsychology as well as cognition of patients surviving, leading to higher incidences of co-morbidities and a shortened life-expectancy.
Specifically reflecting the complex interplay between acute respiratory distress syndrome and long-term outcomes, the last decade has seen a plethora of research elaborating on the long-term outcomes of patients having suffered acute respiratory distress syndrome. The serious functional limitations in patients post critical illness were mainly linked to muscle wasting and weakness, and only secondarily to lung function, neuropathies and other etiologies. Further, the impaired neuropsychological status, especially mediated by posttraumatic stress disorder, and cognitive status have a great impact on the reduced health status and quality-of-life. On the other hand nevertheless, pulmonary function was near normal after up-to 5 years of follow-up. Finally, the impact of acute respiratory distress syndrome (ARDS) and critical illness have on caregivers should not be forgotten, with high levels of depressive symptoms having been reported.
Similar sequela were also described during the severe acute respiratory syndrome (SARS) epidemic in 2003.
The corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical ventilation requirement and in some cases even mandating use of extra-corporeal membrane oxygenation. The median length of stay and of mechanical ventilation support in COVID-19 have been shown to be elevated in comparison to other ARDS etiologies. Being a disease having affected up to 92 million people during the year 2020, with more than 1.9 Million deaths reported, the long-term repercussions are of foremost importance. Health care systems world-wide will be faced with the aftermath of COVID-19, and optimal understanding of the long-term progression of COVID-19 may aid in a better care of critically ill patients and enable specifically targeted rehabilitation programs to improve outcomes.
The overall objective of this study is therefore to evaluate the long-term outcomes of COVID-19 induced critical illness regarding functional status, quality-of-life, neuropsychology and cognition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post Critical Illness due to COVID-19 | – | – |
| Caregivers of Post critically ill COVID-19 patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The project population targeted with this research, consists of a post critically illness, COVID-19 diagnosed population having been admitted to one of the participating centers, as well as their closest caregiver. The closest caregiver is defined as the person spending most of the time with the patient and mainly responsible for the patients daily support and care (professional caregivers will not be included).
Key inclusion criteria (4 listed)
- Previous admission to one of the participating centers for COVID-19 critical illness treatment
- Previously proven SARS-CoV-2 infection
- Critical COVID-19 defined as respiratory failure and/ or shock and/ or multiorgan dysfunction or failure
- Signed Study Informed Consent
Key exclusion criteria (2 listed)
- Age <18 years
- Rejection of the study
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
Change in Pulmonary Function: FEV1
Time frame: Mixed Model assessment of FEV1 over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19
Development of pulmonary function over time post intensive care unit stay due to COVID-19
Change in Quality of Life: SF-36 Score
Time frame: Mixed Model assessment of SF-36 Score over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19
Development of quality of life over time post intensive care unit stay due to COVID-19
Change in Neuropsychological Status: RBANS Score
Time frame: Mixed Model assessment of RBANS Score over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19
Development of Neuropsychological Status over time post intensive care unit stay due to COVID-19
Change in Quality of Life in Caregivers: SF-36 Score
Time frame: Mixed Model assessment of SF-36 Score over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19 of patients
Development of quality of life in Caregivers over time post intensive care unit stay due to COVID-19 of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Reto A Schuepbach, Prof. Dr. principal investigator
Institute of Intensive Care Medicine, University Hospital Zurich
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 Covid19 and ARDS, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 May 2021. 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 Switzerland. 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?
Results are not available in the source record.
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?
Change in Pulmonary Function: FEV1 (time frame: Mixed Model assessment of FEV1 over time at 3, 6 12 and 24 months post discharge from intensive care unit due to critical COVID-19). The study lists 4 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 11 May 2021.