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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360538
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Critical Illness Corona Virus Infection Respiratory Failure Covid-19 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Outcomes of Patients With COVID-19
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID19 positive
ICU patients coronavirus positive
Other: Quality of Life
Physical disability assessment tool
Other Name: SF-36

Other: Impact Event Score
Psychological Sequelae assessment tool
Other Name: 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 Name: SF-36




Primary Outcome Measures :
  1. Quality of Life score [ Time Frame: up to 12 months after discharge ]
    SF-36 score


Secondary Outcome Measures :
  1. cognitive dysfunction [ Time Frame: up to 12 months after discharge ]
    Montreal Cognitive Assessment (MoCA) score

  2. Functional Status Score [ Time Frame: up to 12 months after discharge ]
    (FSS-ICU)

  3. Physical Disability [ Time Frame: up to 12 months after discharge ]
    MRC neuromuscular Assessment

  4. Psychological Sequelae [ Time Frame: up to 12 months after discharge ]
    Impact Event Score


Other Outcome Measures:
  1. hospital anxiety and depression [ Time Frame: up to 12 months after discharge ]
    hospital anxiety and depression scale

  2. ICU related complications [ Time Frame: hospitalization up to 6 weeks ]
    including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness

  3. hospital discharge location [ Time Frame: hospital discharge up to 6 weeks ]
    measure the location (home, rehabilitation center, nursing home

  4. lCU length of stay [ Time Frame: hospitalization up to 6 weeks ]
    number of days admitted to the ICU

  5. hospital length of stay [ Time Frame: hospitalization up to 6 weeks ]
    number of days admitted to the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients admitted to the intensive care unit
Criteria

Inclusion Criteria:

  • adult patients admitted to the ICU

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360538


Contacts
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Contact: Bhakti Patel, MD 773-702-6800 ext 3349 bpatel@medicine.bsd.uchicago.edu
Contact: Anne Pohlman, MSN 773-702-3804 apohlman@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Bhakti Patel, MD    773-702-6800 ext 3349    bpatel@medicine.bsd.uchicago.edu   
Contact: Anne Pohlman, MSN    773-702-3804    apohlman@medicine.bsd.uchicago.edu   
Sub-Investigator: John Kress, MD         
Sub-Investigator: Krysta Wolfe, MD         
Sponsors and Collaborators
University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04360538    
Other Study ID Numbers: 20-0538
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
long term outcomes
mechanical ventilation
noninvasive ventilation
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Virus Diseases
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections