Clinical trial NCT04881266: Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors
Official title: Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
ARDS
Critical Illness
Neurocognitive Dysfunction
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Age \<18 years
* Rejection of the study

Primary outcomes:
measure: Change in Pulmonary Function: FEV1
timeFrame: 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
measure: Change in Quality of Life: SF-36 Score
timeFrame: 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
measure: Change in Neuropsychological Status: RBANS Score
timeFrame: 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
measure: Change in Quality of Life in Caregivers: SF-36 Score
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Institute of Intensive Care Medicine, University Hospital Zurich
name: Reto A Schuepbach, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: