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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04401254




Registration number
NCT04401254
Ethics application status
Date submitted
7/05/2020
Date registered
26/05/2020
Date last updated
28/09/2022

Titles & IDs
Public title
Recovery of Patients From COVID-19 After Critical Illness
Scientific title
The Coronavirus Disease 2019 - Recovery Study
Secondary ID [1] 0 0
COVID-Recovery V1.5 9Feb2022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Critical Illness 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disability-free survival
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Physiotherapy intervention
Timepoint [2] 0 0
During the ICU stay until 3 months
Secondary outcome [1] 0 0
Health status
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Global function
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Cognitive function
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Anxiety and depression
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Screening for post-traumatic distress
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Work Status
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Proportion of patients with COVID-19 who received physiotherapy in ICU
Timepoint [7] 0 0
During the ICU stay until 28 days
Secondary outcome [8] 0 0
The reported barriers to delivering physiotherapy interventions
Timepoint [8] 0 0
During the ICU stay until 28 days
Secondary outcome [9] 0 0
Adverse events during physiotherapy interventions
Timepoint [9] 0 0
During the ICU stay until 28 days
Secondary outcome [10] 0 0
Phenomenological data of the patient and family experience
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Global function
Timepoint [11] 0 0
6 months

Eligibility
Key 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
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous enrolment in this study in a prior ICU admission

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2022
Sample size
Target
Accrual to date
Final
536
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Hospital - Concord
Recruitment hospital [4] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [5] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 0 0
St George Hospital - Kogarah
Recruitment hospital [7] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [8] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [11] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [12] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [13] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [14] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [15] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [16] 0 0
Launceston Hospital - Launceston
Recruitment hospital [17] 0 0
Casey Hospital - Berwick
Recruitment hospital [18] 0 0
Box Hill Hospital (Eastern Health) - Box Hill
Recruitment hospital [19] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [20] 0 0
Dandenong Hospital - Dandenong
Recruitment hospital [21] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [22] 0 0
Footscray Hospital - Footscray
Recruitment hospital [23] 0 0
Frankston Hospital - Frankston
Recruitment hospital [24] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [25] 0 0
Cabrini Health - Malvern
Recruitment hospital [26] 0 0
Australian New Zealand Intensive Care Research Centre - Melbourne
Recruitment hospital [27] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [28] 0 0
Alfred Hospital - Prahran
Recruitment hospital [29] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
2747 - Kingswood
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [8] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment postcode(s) [10] 0 0
4032 - Chermside
Recruitment postcode(s) [11] 0 0
4029 - Herston
Recruitment postcode(s) [12] 0 0
4020 - Redcliffe
Recruitment postcode(s) [13] 0 0
4215 - Southport
Recruitment postcode(s) [14] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
7250 - Launceston
Recruitment postcode(s) [17] 0 0
3806 - Berwick
Recruitment postcode(s) [18] 0 0
3128 - Box Hill
Recruitment postcode(s) [19] 0 0
3168 - Clayton
Recruitment postcode(s) [20] 0 0
3175 - Dandenong
Recruitment postcode(s) [21] 0 0
3065 - Fitzroy
Recruitment postcode(s) [22] 0 0
3011 - Footscray
Recruitment postcode(s) [23] 0 0
3199 - Frankston
Recruitment postcode(s) [24] 0 0
3084 - Heidelberg
Recruitment postcode(s) [25] 0 0
3144 - Malvern
Recruitment postcode(s) [26] 0 0
3004 - Melbourne
Recruitment postcode(s) [27] 0 0
3050 - Parkville
Recruitment postcode(s) [28] 0 0
3004 - Prahran
Recruitment postcode(s) [29] 0 0
3021 - St Albans

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT04401254
Trial related presentations / 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. Erratum In: Am J Respir Crit Care Med. 2022 Sep 1;206(5):653. doi: 10.1164/rccm.v206erratum7.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04401254