NCT04360538

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Apr 2020Jun 2026

Study Start

First participant enrolled

April 8, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

April 16, 2020

Last Update Submit

December 17, 2025

Conditions

Critical IllnessCorona Virus InfectionRespiratory FailureCovid-19

Keywords

long term outcomesmechanical ventilationnoninvasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Quality of Life score

    SF-36 score

    up to 12 months after discharge

Secondary Outcomes (4)

  • cognitive dysfunction

    up to 12 months after discharge

  • Functional Status Score

    up to 12 months after discharge

  • Physical Disability

    up to 12 months after discharge

  • Psychological Sequelae

    up to 12 months after discharge

Other Outcomes (5)

  • hospital anxiety and depression

    up to 12 months after discharge

  • ICU related complications

    hospitalization up to 6 weeks

  • hospital discharge location

    hospital discharge up to 6 weeks

  • +2 more other outcomes

Study Arms (2)

COVID19 positive

ICU patients coronavirus positive

Other: Quality of LifeOther: Impact Event ScoreOther: Hospital anxiety and depression scale

non-COVID19

ICU patients without coronavirus

Other: Quality of Life

Interventions

Quality of LifeOTHER

Physical disability assessment tool

Also known as: SF-36
COVID19 positivenon-COVID19
Impact Event ScoreOTHER

Psychological Sequelae assessment tool

Also known as: IES-R
COVID19 positive
Hospital anxiety and depression scaleOTHER

Psychological Sequelae assessment tool

COVID19 positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients admitted to the intensive care unit

You may qualify if:

  • adult patients admitted to the ICU

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Critical IllnessCoronavirus InfectionsRespiratory InsufficiencyCOVID-19

Interventions

Quality of Life4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiration DisordersRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

April 8, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)