Long Term Outcomes of Patients With COVID-19

Active, not recruiting

• Conditions: Corona Virus Infection; Covid-19; Critical Illness; Respiratory Failure
• Interventions: Other: Quality of Life; Other: Impact Event Score; Other: Hospital anxiety and depression scale

• Registration Number: NCT04360538
• Lead Sponsor: University of Chicago

Brief 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. 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 Timeline

• Study Start: 2020-04-08
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• adult patients admitted to the ICU

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID19 positive	Impact Event Score	ICU patients coronavirus positive
COVID19 positive	Quality of Life	ICU patients coronavirus positive
non-COVID19	Quality of Life	ICU patients without coronavirus
COVID19 positive	Hospital anxiety and depression scale	ICU patients coronavirus positive

Primary Outcome Measures

Name	Time	Method
Quality of Life score	up to 12 months after discharge	SF-36 score

Secondary Outcome Measures

Name	Time	Method
Psychological Sequelae	up to 12 months after discharge	Impact Event Score
cognitive dysfunction	up to 12 months after discharge	Montreal Cognitive Assessment (MoCA) score
Functional Status Score	up to 12 months after discharge	(FSS-ICU)
Physical Disability	up to 12 months after discharge	MRC neuromuscular Assessment

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States