Long Term Outcomes of Patients With COVID-19 (COVID19 LTFU)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid-19; Critical Illness; Respiratory Failure; Corona Virus Infection
• Intervention / Treatment: Other: Quality of Life; Other: Impact Event Score; Other: Hospital anxiety and depression scale

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients admitted to the intensive care unit

Description

Inclusion Criteria:

• adult patients admitted to the ICU

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID19 positive; ICU patients coronavirus positive	Other: Quality of Life; Physical disability assessment tool; Other Names: SF-36; Other: Impact Event Score; Psychological Sequelae assessment tool; Other Names: IES-R; Other: Hospital anxiety and depression scale; Psychological Sequelae assessment tool
non-COVID19; ICU patients without coronavirus	Other: Quality of Life; Physical disability assessment tool; Other Names: SF-36

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life score	SF-36 score	up to 12 months after discharge

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital anxiety and depression	hospital anxiety and depression scale	up to 12 months after discharge
ICU related complications	including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness	hospitalization up to 6 weeks
hospital discharge location	measure the location (home, rehabilitation center, nursing home	hospital discharge up to 6 weeks
lCU length of stay	number of days admitted to the ICU	hospitalization up to 6 weeks
hospital length of stay	number of days admitted to the hospital	hospitalization up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; noninvasive ventilation; long term outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Respiratory Insufficiency; Critical Illness; Coronavirus Infections; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements; Quality of Life; 4-amino-4'-hydroxylaminodiphenylsulfone
• Other Study ID Numbers: 20-0538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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