Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000799954p
Ethics application status
Not yet submitted
Date submitted
18/07/2020
Date registered
10/08/2020
Date last updated
10/08/2020
Date data sharing statement initially provided
10/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Long-term Impact in Intensive Care Survivors of Coronavirus disease-19 (COVID-19)
Scientific title
Long-term Impact in Intensive Care Survivors of Coronavirus disease-19 (COVID-19)
Secondary ID [1] 301821 0
none
Universal Trial Number (UTN)
Trial acronym
AFTERCOR
Linked study record
ACTRN12620000421932
Patients included for long-term follow-up in this study have been previously enrolled in the ECMOCARD study.

Health condition
Health condition(s) or problem(s) studied:
COVID-19 related cardiac, respiratory, neurological, cognitive and psychological long-term outcome 318297 0
Condition category
Condition code
Respiratory 316308 316308 0 0
Other respiratory disorders / diseases
Cardiovascular 316309 316309 0 0
Other cardiovascular diseases
Infection 316310 316310 0 0
Other infectious diseases
Mental Health 316311 316311 0 0
Depression
Neurological 316312 316312 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients previously enrolled in ECMOCARD will be approached for informed consent for follow-up assessments up to 2 years. Following discharge from the hospital, recovery up to two years of the following aspects/functions will be assessed:
- Health-related quality of life by answering questionnaires (taking approximately 1h at every follow-up visit)
- Dynamics of organs dysfunction and recovery (blood draw, taking 5 minutes at every follow-up visit; )
- Pulmonary function tests (taking approximately 2h at every follow-up visit)
Follow-up assessments with the complete work-up will be at 3, 6, 12, 18 and 24 months.
Intervention code [1] 318121 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324482 0
Health-related quality of life as assessed by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the St. George Respiratory Questionnaire (SGRQ)
Timepoint [1] 324482 0
3, 6, 12, 18 and 24 months after ICU discharge
Primary outcome [2] 324624 0
Dynamics of organ dysfunction and recovery as assessed by hospitalisation since hospital discharge or last follow-up visit for neurological, cardiac, renal or pulmonary decompensation. Additionally blood samples will be taken to assess liver and kidney function.
Timepoint [2] 324624 0
3, 6, 12, 18 and 24 months following ICU discharge
Primary outcome [3] 324625 0
Pulmonary function as assessed by pulmonary imaging, pulmonary function tests and arterial blood gas analysis
Timepoint [3] 324625 0
3, 6, 12, 18 and 24 months following ICU discharge
Secondary outcome [1] 384780 0
depression as assessed by the Patient-Health Questionnaire 9
Timepoint [1] 384780 0
3, 6, 12, 18 and 24 months after ICU discharge
Secondary outcome [2] 385240 0
cognitive impairment as assessed by the Montreal Cognitive Assessment
Timepoint [2] 385240 0
3, 6, 12, 18 and 24 months following ICU discharge

Eligibility
Key inclusion criteria
Laboratory-confirmed COVID-19 infection by real-time PCR
Written informed consent from the patient at the time of discharge from the ICU
Previous enrolment into the ECMOCARD observational study
Aged older or equal than 18 years
Discharge from an intensive care unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy at time of infection
Patients unable to complete long-term follow-up, due to logistical problems
Patient paralysed due to pre-existing neurological condition before being admitted to hospital for COVID-19
History of pulmonary resection
Previous pulmonary transplant

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Summary statistics will be used to describe the sample characteristics at ICU discharge. Plots will be used to summarise outcomes over time for both individual patients and averages by groups. Multivariable regression analyses will be used to examine associations between baseline characteristics and severity variables upon admission and discharge in the ICU, and how these impact outcomes at 3, 6, 12, 18 and 24 months after ICU discharge. The residuals of the models will be checked for multi-modality, skew and outliers. Models will also be checked for collinearity and influential values. We will use Kaplan-Meier methods to appraise survival probabilities from the date of discharge from the ICU. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/08/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 17118 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 17119 0
The Alfred - Melbourne
Recruitment hospital [3] 17120 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 30794 0
4032 - Chermside
Recruitment postcode(s) [2] 30795 0
3004 - Melbourne
Recruitment postcode(s) [3] 30796 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 22763 0
United States of America
State/province [1] 22763 0
Country [2] 22764 0
South Africa
State/province [2] 22764 0
Country [3] 22765 0
Ireland
State/province [3] 22765 0
Country [4] 22766 0
Japan
State/province [4] 22766 0
Country [5] 22767 0
Argentina
State/province [5] 22767 0
Country [6] 22768 0
Brazil
State/province [6] 22768 0
Country [7] 22769 0
Spain
State/province [7] 22769 0
Country [8] 22770 0
Italy
State/province [8] 22770 0
Country [9] 22771 0
Hong Kong
State/province [9] 22771 0
Country [10] 22772 0
Germany
State/province [10] 22772 0

Funding & Sponsors
Funding source category [1] 306249 0
Charities/Societies/Foundations
Name [1] 306249 0
The Wesley Medical Research Foundation
Country [1] 306249 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Critical Care Research Group
Address
Critical Care Research Group
Level 3 | Clinical Sciences Building
The Prince Charles Hospital
Chermside Qld 4032
Australia
Country
Australia
Secondary sponsor category [1] 306734 0
None
Name [1] 306734 0
Address [1] 306734 0
Country [1] 306734 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306458 0
Metro North; Human Ethics Commitee
Ethics committee address [1] 306458 0
The Prince Charles Hospital, Ethics Committee
627 Rode Rd,
Chermside QLD 4032
Ethics committee country [1] 306458 0
Australia
Date submitted for ethics approval [1] 306458 0
15/08/2020
Approval date [1] 306458 0
Ethics approval number [1] 306458 0

Summary
Brief summary
Long-term impact of COVID-19 on neurological, pulmonary, renal, liver function and health-related quality of life is unknown. We theorise that COVID-19 patients admitted to the ICU will have various degrees of organ dysfunctions up to 2 years post ICU discharge, which could result in an impaired quality of life and prolonged recovery.
This is a multi-centre international prospective study in survivors of COVID-19, who required admission to the intensive care unit, to assess the health-related quality of life, the dynamics of organs dysfunction and recovery, cognitive outcome and pulmonary function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103954 0
A/Prof Gianluigi Libassi
Address 103954 0
The Critical Care Research Group
University of Queensland
Level 3 | Clinical Sciences Building
Chermside Qld 4032
Australia
Country 103954 0
Australia
Phone 103954 0
+61 7 3139 6880
Fax 103954 0
Email 103954 0
[email protected]
Contact person for public queries
Name 103955 0
Dr Karin Wildi
Address 103955 0
The Critical Care Research Group
University of Queensland
Level 3 | Clinical Sciences Building
Chermside Qld 4032
Australia
Country 103955 0
Australia
Phone 103955 0
+61 7 3139 6880
Fax 103955 0
Email 103955 0
[email protected]
Contact person for scientific queries
Name 103956 0
Dr Karin Wildi
Address 103956 0
The Critical Care Research Group
University of Queensland
Level 3 | Clinical Sciences Building
Chermside Qld 4032
Australia
Country 103956 0
Australia
Phone 103956 0
+61 7 3139 6880
Fax 103956 0
Email 103956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDesign and Rationale of a Prospective International Follow-Up Study on Intensive Care Survivors of COVID-19: The Long-Term Impact in Intensive Care Survivors of Coronavirus Disease-19-AFTERCOR.2021https://dx.doi.org/10.3389/fmed.2021.738086
N.B. These documents automatically identified may not have been verified by the study sponsor.