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COVID-19NCT04401254

Recovery of Patients From COVID-19 After Critical Illness

An observational study of COVID-19 and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 29 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
COVID-19, Critical Illness
How many people
536 participants
Where
29 sitesAustralia
Study dates
1 Jul 2020to 30 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Critically ill patients with COVID-19 admitted to an intensive care unit

Who may be able to join

  • COVID-19 patients who have been admitted to ICU for > 24 hours
  • Patients aged over 17 years
  • Persistent critical illness cohort
  • As above
  • An ICU admission of at least 10 consecutive days

Who cannot join

  • Previous enrolment in this study in a prior ICU admission

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Australia29 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Casey Hospital

    Berwick, Victoria, 3806

  • Box Hill Hospital (Eastern Health)

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Hospital

    Concord, New South Wales, 2139

  • Dandenong Hospital

    Dandenong, Victoria, 3175

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Launceston Hospital

    Launceston, Tasmania, 7250

  • Cabrini Health

    Malvern, Victoria, 3144

  • Australian New Zealand Intensive Care Research Centre

    Melbourne, Victoria, 3004

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Alfred Hospital

    Prahran, Victoria, 3004

  • Redcliffe Hospital

    Redcliffe, Queensland, 4020

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

  • Gold Coast Hospital

    Southport, Queensland, 4215

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: The Coronavirus Disease 2019 - Recovery Study

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.

Read more

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

Keywords
recovery
Medical subject headings
COVID-19, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disability-free survival

    a composite measure of WHODAS 2.0 - 12 level and hospital survival

    Measured: 6 months

  2. Physiotherapy intervention

    The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes

    Measured: During the ICU stay until 3 months

Secondary outcomes (11)

  1. Health status

    Health related quality of life measured with EQ5D-5L score from 0 to 100

    Measured: 6 months

  2. Global function

    World Health Organization Disability Assessment Schedule 2.0 12L

    Measured: 6 months

  3. Cognitive function

    Montreal Cognitive Assessment Blind

    Measured: 6 months

  4. Anxiety and depression

    Hospital Anxiety and Depression Scale

    Measured: 6 months

  5. Screening for post-traumatic distress

    Impact of Events Scale Revised

    Measured: 6 months

  6. Work Status

    WHODAS 2.0

    Measured: 6 months

  7. Proportion of patients with COVID-19 who received physiotherapy in ICU

    Measured: During the ICU stay until 28 days

  8. The reported barriers to delivering physiotherapy interventions

    Physiotherapist reported barriers to delivering the intervention

    Measured: During the ICU stay until 28 days

  9. Adverse events during physiotherapy interventions

    Adverse events that require the intervention to be ceased for medical intervention

    Measured: During the ICU stay until 28 days

  10. Phenomenological data of the patient and family experience

    Qualitative interviews

    Measured: 6 months

  11. Global function

    Global Rating of Change

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
536 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04401254
Sponsor's protocol ID
COVID-Recovery V1.5 9Feb2022
Status last verified
Sep 2022
First submitted
7 May 2020
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared if approved by the steering committee and with ethical approvals.

Publications

  • Hodgson CL, Higgins AM, Bailey MJ, Mather AM, Beach L, Bellomo R, Bissett B, Boden IJ, Bradley S, Burrell A, Cooper DJ, Fulcher BJ, Haines KJ, Hodgson IT, Hopkins J, Jones AYM, Lane S, Lawrence D, van der Lee L, Liacos J, Linke NJ, Gomes LM, Nickels M, Ntoumenopoulos G, Myles PS, Patman S, Paton M, Pound G, Rai S, Rix A, Rollinson TC, Tipping CJ, Thomas P, Trapani T, Udy AA, Whitehead C, Anderson S, Neto AS; COVID-Recovery Study Investigators and the ANZICS Clinical Trials Group. Comparison of 6-Month Outcomes of Survivors of COVID-19 versus Non-COVID-19 Critical Illness. Am J Respir Crit Care Med. 2022 May 15;205(10):1159-1168. doi: 10.1164/rccm.202110-2335OC.

    PubMed 35258437

  • Hodgson CL, Higgins AM, Bailey MJ, Mather AM, Beach L, Bellomo R, Bissett B, Boden IJ, Bradley S, Burrell A, Cooper DJ, Fulcher BJ, Haines KJ, Hopkins J, Jones AYM, Lane S, Lawrence D, van der Lee L, Liacos J, Linke NJ, Gomes LM, Nickels M, Ntoumenopoulos G, Myles PS, Patman S, Paton M, Pound G, Rai S, Rix A, Rollinson TC, Sivasuthan J, Tipping CJ, Thomas P, Trapani T, Udy AA, Whitehead C, Hodgson IT, Anderson S, Neto AS; COVID-Recovery Study Investigators and the ANZICS Clinical Trials Group. The impact of COVID-19 critical illness on new disability, functional outcomes and return to work at 6 months: a prospective cohort study. Crit Care. 2021 Nov 8;25(1):382. doi: 10.1186/s13054-021-03794-0.

    PubMed 34749756

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 29 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability-free survival (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04401254, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

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