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Long Term Outcomes of Patients With COVID-19

NCT ID: NCT04360538

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-08

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Critical Illness Corona Virus Infection Respiratory Failure Covid-19

Keywords

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long term outcomes mechanical ventilation noninvasive ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID19 positive

ICU patients coronavirus positive

Quality of Life

Intervention Type OTHER

Physical disability assessment tool

Impact Event Score

Intervention Type OTHER

Psychological Sequelae assessment tool

Hospital anxiety and depression scale

Intervention Type OTHER

Psychological Sequelae assessment tool

non-COVID19

ICU patients without coronavirus

Quality of Life

Intervention Type OTHER

Physical disability assessment tool

Interventions

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Quality of Life

Physical disability assessment tool

Intervention Type OTHER

Impact Event Score

Psychological Sequelae assessment tool

Intervention Type OTHER

Hospital anxiety and depression scale

Psychological Sequelae assessment tool

Intervention Type OTHER

Other Intervention Names

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SF-36 IES-R

Eligibility Criteria

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Inclusion Criteria

* adult patients admitted to the ICU

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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20-0538

Identifier Type: -

Identifier Source: org_study_id