Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors (LUNGTERMcov)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Critical Illness; Covid19; ARDS; Neurocognitive Dysfunction

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Post Critical Illness due to COVID-19
Caregivers of Post critically ill COVID-19 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Function: FEV1	Development of pulmonary function over time post intensive care unit stay due to COVID-19	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Reto A Schuepbach, Prof. Dr., Institute of Intensive Care Medicine, University Hospital Zurich

Study record dates

Study Major Dates

• Study Start (Anticipated): May 7, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: May 9, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 9, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurocognitive Disorders; Disease Attributes; Cognition Disorders; COVID-19; Cognitive Dysfunction; Critical Illness
• Other Study ID Numbers: 2021-00209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No