Long Term Outcomes of Patients With COVID-19

Covid-19 Clinical Trial

— COVID19 LTFU  

Official title:

Long Term Outcomes of Patients With COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04360538
• Other study ID #: 20-0538
• Status: Active, not recruiting
• Start date: April 8, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients admitted to the ICU

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Quality of Life
Physical disability assessment tool
• Impact Event Score
Psychological Sequelae assessment tool
• Hospital anxiety and depression scale
Psychological Sequelae assessment tool

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hospital anxiety and depression	hospital anxiety and depression scale	up to 12 months after discharge
Other	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
Other	hospital discharge location	measure the location (home, rehabilitation center, nursing home	hospital discharge up to 6 weeks
Other	lCU length of stay	number of days admitted to the ICU	hospitalization up to 6 weeks
Other	hospital length of stay	number of days admitted to the hospital	hospitalization up to 6 weeks
Primary	Quality of Life score	SF-36 score	up to 12 months after discharge
Secondary	cognitive dysfunction	Montreal Cognitive Assessment (MoCA) score	up to 12 months after discharge
Secondary	Functional Status Score	(FSS-ICU)	up to 12 months after discharge
Secondary	Physical Disability	MRC neuromuscular Assessment	up to 12 months after discharge
Secondary	Psychological Sequelae	Impact Event Score	up to 12 months after discharge