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Recovery of Patients From COVID-19 After Critical Illness

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: NCT04401254
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
The Alfred
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Brief Summary:

Patients who are critically ill with COVID-19 requiring life support in an intensive care unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does not know what effect the disease, the ICU admission, physiotherapy interventions and life support have on their long-term quality of life and whether they can return to their pre-illness level of function following ICU.

COVID-Recovery will describe the physiotherapy interventions delivered to critically ill patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU survivors to assess disability-free survival and quality of life at 6 months after ICU admission. Additionally, COVID-Recovery will identify if there are predictors of disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be invited to receive a telephone questionnaire at 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU discharge.

To describe the experience of critical illness in survivors of COVID-19 and their family members.

To explore and describe functional recovery, respiratory system function and respiratory health morbidity up to 6 months after ICU admission in persistently critically ill adults with COVID-19


Condition or disease
COVID-19 Critical Illness

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Coronavirus Disease 2019 - Recovery Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Disability-free survival [ Time Frame: 6 months ]
    a composite measure of WHODAS 2.0 - 12 level and hospital survival

  2. Physiotherapy intervention [ Time Frame: During the ICU stay until 3 months ]
    The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes


Secondary Outcome Measures :
  1. Health status [ Time Frame: 6 months ]
    Health related quality of life measured with EQ5D-5L score from 0 to 100

  2. Global function [ Time Frame: 6 months ]
    World Health Organization Disability Assessment Schedule 2.0 12L

  3. Cognitive function [ Time Frame: 6 months ]
    Montreal Cognitive Assessment Blind

  4. Anxiety and depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depression Scale

  5. Screening for post-traumatic distress [ Time Frame: 6 months ]
    Impact of Events Scale Revised

  6. Work Status [ Time Frame: 6 months ]
    WHODAS 2.0

  7. Proportion of patients with COVID-19 who received physiotherapy in ICU [ Time Frame: During the ICU stay until 28 days ]
  8. The reported barriers to delivering physiotherapy interventions [ Time Frame: During the ICU stay until 28 days ]
    Physiotherapist reported barriers to delivering the intervention

  9. Adverse events during physiotherapy interventions [ Time Frame: During the ICU stay until 28 days ]
    Adverse events that require the intervention to be ceased for medical intervention

  10. Phenomenological data of the patient and family experience [ Time Frame: 6 months ]
    Qualitative interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients with COVID-19 admitted to an intensive care unit
Criteria

Inclusion Criteria:

  1. COVID-19 patients who have been admitted to ICU for > 24 hours
  2. Patients aged over 17 years

Persistent critical illness cohort

  1. As above
  2. An ICU admission of at least 10 consecutive days

Exclusion Criteria:

  • Previous enrolment in this study in a prior ICU admission

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): NCT04401254


Contacts
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Contact: Carol Hodgson, PhD +61448674532 carol.hodgson@monash.edu
Contact: Allison Bone, BN +61402147834 allison.bone@monash.edu

Locations
Show Show 33 study locations
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
The Alfred
Investigators
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Principal Investigator: Carol Hodgson, PhD Monash University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT04401254    
Other Study ID Numbers: COVID-Recovery V1.5 9Feb2022
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared if approved by the steering committee and with ethical approvals.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after completion of the study for 12 months
Access Criteria: Email the Chief Investigator

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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 Australian and New Zealand Intensive Care Research Centre:
recovery
Additional relevant MeSH terms:
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COVID-19
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes