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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD will be shared if approved by the steering committee and with ethical approvals.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
12 months after completion of the study for 12 months
Available to whom?
Email the Chief Investigator
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04401254