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

NCT04881266 | Unknown

• 1 other identifier: 2021-00209
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; ARDS; Critical Illness; Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Post Critical Illness due to COVID-19

Caregivers of Post critically ill COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Rejection of the study

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Serum

MeSH Terms

Conditions

COVID-19; Critical Illness; Cognition Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Reto A Schuepbach, Prof. Dr.

  Institute of Intensive Care Medicine, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: May 11, 2021
• Study Start: May 7, 2021
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

CH (1)