Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000421932
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
30/03/2020
Date last updated
8/09/2020
Date data sharing statement initially provided
30/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
COVID-19 Critical Care Consortium Observational Study Incorporating the Extracorporeal Membrane Oxygenation for 2019 Novel Coronavirus Acute Respiratory Disease (ECMOCARD)
Scientific title
COVID-19 Critical Care Consortium Observational Study Incorporating the Extracorporeal Membrane Oxygenation for 2019 Novel Coronavirus Acute Respiratory Disease (ECMOCARD)
Secondary ID [1] 300393 0
None
Universal Trial Number (UTN)
Trial acronym
COVID-19 CCC inc ECMOCARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
2019 SARS-CoV-2 Infection and coronavirus disease (COVID-19) 316018 0
Respiratory Infection 316019 0
Condition category
Condition code
Infection 314294 314294 0 0
Studies of infection and infectious agents
Respiratory 314295 314295 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Months
Description of intervention(s) / exposure
In patients with suspected or confirmed 2019-nCoV who require admission to the intensive care unit mechanical ventilation and extracorporeal membrane oxygenation (ECMO). It is expected that this study will not require individual patient consent. This study is in effect a large-scale clinical audit during a global health emergency, as all data is already recorded as part of routine clinical care, therefore justifying participant enrolment using a waiver of consent. Retrospective data will be sourced from all collaborating hospitals across Australia from January 2020 to March 2020. Whereas, international hospitals will provide their retrospective data between January 2019 and march 2020. Prospective data will be collected in Australian and International hospitals until completion of COVID-19 global epidemic, as judged by the World Health Organization. The total duration of observation per participant will be until hospital discharge or 28 days post intensive care unit admission, whichever comes later. The study will combine prospective observation, and retrospective observations sourced from clinical charts.
Intervention code [1] 316678 0
Diagnosis / Prognosis
Comparator / control treatment
This study is an observational study, therefore it will not have a control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322683 0
Mortality
Timepoint [1] 322683 0
At hospital discharge or 28 days post intensive care unit admission, whichever comes later.
Secondary outcome [1] 379284 0
Through assessment of medical records we will compute incidence of intensive care unit admission among patients with suspected or confirmed 2019-nCoV infection.
Timepoint [1] 379284 0
Until hospital discharge
Secondary outcome [2] 380502 0
Cardiac arrest
Assessed through medical records
Timepoint [2] 380502 0
Upon commencement of mechanical ventilation
Secondary outcome [3] 380504 0
Location of ECMO cannulation
Assessed through medical records
Timepoint [3] 380504 0
Upon commencement of ECMO
Secondary outcome [4] 380535 0
ECMO blood flow rate
Assessed through medical records and ecmo machine data
Timepoint [4] 380535 0
Daily until ECMO support is ceased or 28 days post intensive care unit admission, whichever occurs first.
Secondary outcome [5] 380537 0
Type and source of infectious complications, i.e. ventilator-associated pneumonia, assessed through medical records and data-linkage to medical records
Timepoint [5] 380537 0
Daily until ICU discharge.
Secondary outcome [6] 380539 0
Length of hospital Stay
Assessed through medical records

Timepoint [6] 380539 0
At hospital discharge or 28 days post intensive care unit admission, whichever comes later.
Secondary outcome [7] 381034 0
Ventilatory support prior to mechanical ventilation
Assessed through medical records
Timepoint [7] 381034 0
Upon commencement of mechanical ventilation
Secondary outcome [8] 381035 0
Blood gas analysis
Timepoint [8] 381035 0
Upon commencement of mechanical ventilation
Secondary outcome [9] 381036 0
Use of vasoactive drugs
Assessed through medical records
Timepoint [9] 381036 0
Upon commencement of mechanical ventilation
Secondary outcome [10] 381037 0
Use of cardiac assist devices
Assessed through medical records
Timepoint [10] 381037 0
Upon commencement of mechanical ventilation
Secondary outcome [11] 381038 0
Antibiotics
Assessed through medical records
Timepoint [11] 381038 0
Upon commencement of mechanical ventilation
Secondary outcome [12] 381039 0
Type and Manufacturer of centrifugal blood pump driven circuit
Assessed through medical records and examination ECMO machine
Timepoint [12] 381039 0
Upon commencement of ECMO
Secondary outcome [13] 381040 0
Type and Manufacturer of low-resistance oxygenator
Assessed through medical records and examination ECMO machine
Timepoint [13] 381040 0
Upon commencement of ECMO
Secondary outcome [14] 381041 0
Type of ECMO: Venous-venous; Venous-arterial
Assessed through medical records
Timepoint [14] 381041 0
Upon commencement of ECMO
Secondary outcome [15] 381042 0
Cardiac arrest
Assessed through medical records
Timepoint [15] 381042 0
Upon commencement of ECMO
Secondary outcome [16] 381043 0
Ventilatory settings prior to ECMO
Assessed through medical records
Timepoint [16] 381043 0
Upon commencement of ECMO
Secondary outcome [17] 381044 0
Body position before start of ECMO
Assessed through medical records
Timepoint [17] 381044 0
Upon commencement of ECMO
Secondary outcome [18] 381045 0
Use of neuromuscular blockade
Assessed through medical records
Timepoint [18] 381045 0
Upon commencement of ECMO
Secondary outcome [19] 381046 0
Use of recruitment manoeuvres
Assessed through medical records
Timepoint [19] 381046 0
Upon commencement of ECMO
Secondary outcome [20] 381047 0
Use of inhaled nitric oxide
Assessed through medical records
Timepoint [20] 381047 0
Upon commencement of ECMO
Secondary outcome [21] 381048 0
Arterial blood gases
Timepoint [21] 381048 0
Upon commencement of ECMO
Secondary outcome [22] 381049 0
Use of continuous renal replacement therapy
Assessed through medical records
Timepoint [22] 381049 0
Upon commencement of ECMO
Secondary outcome [23] 381050 0
Use of vasoactive drugs
Assessed through medical records
Timepoint [23] 381050 0
Upon commencement of ECMO
Secondary outcome [24] 381051 0
Use of cardiac assist devices
Assessed through medical records
Timepoint [24] 381051 0
Upon commencement of ECMO
Secondary outcome [25] 381052 0
Use of antibiotics
Assessed through medical records
Timepoint [25] 381052 0
Upon commencement of ECMO
Secondary outcome [26] 381053 0
Transfused blood products
Assessed through medical records
Timepoint [26] 381053 0
Upon commencement of ECMO
Secondary outcome [27] 381054 0
ECMO gas flow rate
Assessed through medical records and ecmo data
Timepoint [27] 381054 0
Daily until ECMO support is ceased or 28 days post intensive care unit admission, whichever occurs first.
Secondary outcome [28] 381055 0
Anticoagulation during ECMO
Assessed through medical records
Timepoint [28] 381055 0
Daily until ECMO support is ceased or 28 days post intensive care unit admission, whichever occurs first
Secondary outcome [29] 381056 0
Frequency of ECMO circuit change
Assessed through medical records
Timepoint [29] 381056 0
Daily until ECMO support is ceased or 28 days post intensive care unit admission, whichever occurs first.
Secondary outcome [30] 381058 0
Mechanical ventilator settings
Assessed through medical records and mechanical ventilator data.
Timepoint [30] 381058 0
Daily until ventilatory support with mechanical ventilator is ceased
Secondary outcome [31] 381059 0
Vasoactive support
Assessed through medical records
Timepoint [31] 381059 0
Daily until ICU discharge
Secondary outcome [32] 381060 0
Organ dysfunctions
Assessed through medical records and laboratory results
Timepoint [32] 381060 0
Daily until hospital discharge or 28 days post intensive care unit admission, whichever comes later.
Secondary outcome [33] 381061 0
Transfused blood products
Assessed through medical records
Timepoint [33] 381061 0
Daily until ICU discharge
Secondary outcome [34] 381066 0
Type and source of hemorrhagic complications, i.e. subarachnoid haemorrhage, assessed through medical chart and data-linkage to medical chart
Assessed through medical records
Timepoint [34] 381066 0
Daily until ICU discharge
Secondary outcome [35] 381068 0
Other complications, i.e. pneumothorax assessed through medical chart and data linkage to medical chart
Timepoint [35] 381068 0
Daily until ICU discharge
Secondary outcome [36] 381070 0
Length of ICU stay
Assessed through medical records
Timepoint [36] 381070 0
At hospital discharge or 28 days post intensive care unit admission, whichever comes later.
Secondary outcome [37] 381072 0
Duration of mechanical ventilation
Assessed through medical records
Timepoint [37] 381072 0
At hospital discharge or 28 days post intensive care unit admission, whichever comes later.
Secondary outcome [38] 381073 0
Duration of ECMO
Assessed through medical records
Timepoint [38] 381073 0
At hospital discharge or 28 days post intensive care unit admission, whichever comes later.
Assessed through medical records
Secondary outcome [39] 386703 0
Coagulatory and thrombotic derangement assessed via:
1. Laboratory parameters (PT aPTT INR ACT LDH; Fibrinogen; Plasma Free Hemoglobin Anti-Xa; Ferritin; D-Dimer; IL-6; CRP; Lupus Anticoagulant Protein C; Von Willebrand Factor Antigen; Antithrombin; Ristocetin)
2. Rotem or TEG parameters
3. Medications and dosing (Heparin; Heparin infusion (IV); Low Molecular weight heparin; Warfarin; Rivaroxaban; Apixaban; Aspirin; Argatroban; Bivalrudin; DDAVP; AMICAR (epsilon-Aminocaproic acid); Tranexamic Acid; Protamine; Andexanet Alfa)
4. Bleeding and thrombosis events
5. Administered blood products
Timepoint [39] 386703 0
Daily during mechanical ventilation

Eligibility
Key inclusion criteria
1. Clinical suspicion or laboratory-confirmed COVID-19 infection by real-time PCR and/or next-generation sequencing
2. Admission to an intensive care unit
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients treated with mechanical ventilation for other concomitant causes.
2. Patients treated with ECMO for other concomitant causes

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
No sample size analysis has been conducted, due the rapidly evolving status of the infection and the urgent need to collect a large number of data to characterise the novel infection

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/03/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
10000
Accrual to date
2141
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
Recruitment postcode(s) [1] 29133 0
4032 - Chermside
Recruitment outside Australia
Country [1] 22276 0
Hong Kong
State/province [1] 22276 0
Country [2] 22277 0
Taiwan, Province Of China
State/province [2] 22277 0
Country [3] 22278 0
Indonesia
State/province [3] 22278 0
Country [4] 22279 0
Korea, Republic Of
State/province [4] 22279 0
Country [5] 22280 0
Japan
State/province [5] 22280 0
Country [6] 22379 0
Italy
State/province [6] 22379 0
Country [7] 22380 0
Singapore
State/province [7] 22380 0
Country [8] 22381 0
Viet Nam
State/province [8] 22381 0
Country [9] 22382 0
Thailand
State/province [9] 22382 0
Country [10] 22428 0
United Kingdom
State/province [10] 22428 0
Country [11] 22429 0
United States of America
State/province [11] 22429 0
Country [12] 22924 0
Taiwan, Province Of China
State/province [12] 22924 0
Country [13] 22925 0
Netherlands
State/province [13] 22925 0
Country [14] 22926 0
Belgium
State/province [14] 22926 0
Country [15] 22927 0
Kuwait
State/province [15] 22927 0
Country [16] 22928 0
Saudi Arabia
State/province [16] 22928 0
Country [17] 22929 0
Austria
State/province [17] 22929 0
Country [18] 22930 0
Philippines
State/province [18] 22930 0
Country [19] 22931 0
Estonia
State/province [19] 22931 0
Country [20] 22932 0
Canada
State/province [20] 22932 0
Country [21] 22933 0
India
State/province [21] 22933 0
Country [22] 22934 0
Spain
State/province [22] 22934 0
Country [23] 22935 0
Argentina
State/province [23] 22935 0
Country [24] 22936 0
Colombia
State/province [24] 22936 0
Country [25] 22937 0
Chile
State/province [25] 22937 0
Country [26] 22938 0
Germany
State/province [26] 22938 0
Country [27] 22939 0
Brazil
State/province [27] 22939 0
Country [28] 22940 0
Ireland
State/province [28] 22940 0
Country [29] 22941 0
Poland
State/province [29] 22941 0
Country [30] 22942 0
South Africa
State/province [30] 22942 0
Country [31] 22943 0
Qatar
State/province [31] 22943 0
Country [32] 22944 0
Egypt
State/province [32] 22944 0
Country [33] 22945 0
Sweden
State/province [33] 22945 0
Country [34] 22946 0
Croatia
State/province [34] 22946 0
Country [35] 22947 0
Luxembourg
State/province [35] 22947 0
Country [36] 22948 0
Ukraine
State/province [36] 22948 0
Country [37] 22949 0
Switzerland
State/province [37] 22949 0
Country [38] 22950 0
Turkey
State/province [38] 22950 0
Country [39] 22951 0
Mexico
State/province [39] 22951 0
Country [40] 22952 0
United Arab Emirates
State/province [40] 22952 0
Country [41] 22953 0
Lebanon
State/province [41] 22953 0
Country [42] 22954 0
Kenya
State/province [42] 22954 0
Country [43] 22955 0
Tunisia
State/province [43] 22955 0
Country [44] 22956 0
Zimbabwe
State/province [44] 22956 0
Country [45] 22957 0
Morocco
State/province [45] 22957 0
Error

Funding & Sponsors
Funding source category [1] 304815 0
Charities/Societies/Foundations
Name [1] 304815 0
The Prince Charles Hospital Foundation
Country [1] 304815 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Extracorporeal Life Support Organisation
Address
ELSO Office 2800 Plymouth Rd Building 300, Room 303. Ann Arbor, MI, 48109
Country
United States of America
Secondary sponsor category [1] 305442 0
University
Name [1] 305442 0
University of Queensland
Address [1] 305442 0
St Lucia, Brisbane, Queensland, Australia, 4072
Country [1] 305442 0
Australia
Other collaborator category [1] 281220 0
Other Collaborative groups
Name [1] 281220 0
International Severe Acute Respiratory and Emerging Infection Consortium
Address [1] 281220 0
University of Oxford
New Richards Building
Old Road Campus
Roosevelt Drive
Oxford, UK, OX1 2JD
Country [1] 281220 0
United Kingdom
Other collaborator category [2] 281469 0
University
Name [2] 281469 0
Monash University
Address [2] 281469 0
Wellington Rd, Clayton VIC 3800
Country [2] 281469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305554 0
The Alfred Hospital
Ethics committee address [1] 305554 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 305554 0
Australia
Date submitted for ethics approval [1] 305554 0
27/02/2020
Approval date [1] 305554 0
02/03/2020
Ethics approval number [1] 305554 0
Project 108/20
Ethics committee name [2] 305584 0
Policlinico Gemelli
Ethics committee address [2] 305584 0
Largo Agostino Gemelli, 8, 00168 Roma
Ethics committee country [2] 305584 0
Italy
Date submitted for ethics approval [2] 305584 0
27/02/2020
Approval date [2] 305584 0
05/03/2020
Ethics approval number [2] 305584 0
3029

Summary
Brief summary
We hypothesize that a significant percentage of patients with suspected or confirmed COVID-19 infection will require admission to the intensive care unit, mechanical ventilation and ECMO for refractory hypoxemia., In addition, it is hypothesized that a substantial proportion of patients will also present with concurrent coagulation disorders and thrombosis.
Objectives:
To describe clinical features; severity of pulmonary dysfunction; incidence of ICU admission and use of mechanical ventilation, coagulatory and thrombotic derangement, and ECMO technical characteristics; duration of ECMO; complications; and survival of patients with suspected or confirmed COVID-19.
Trial website
https://www.elso.org/COVID19/ECMOCARD.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99690 0
Prof John Fraser
Address 99690 0
Critical Care Research Group
The Prince Charles Hospital
Clinical Science Building
627 Rode Rd
Chermside QLD 4032
QLD
Country 99690 0
Australia
Phone 99690 0
+61 731396880
Fax 99690 0
Email 99690 0
[email protected]
Contact person for public queries
Name 99691 0
A/Prof Gianluigi Li Bassi
Address 99691 0
Critical Care Research Group
The Prince Charles Hospital
Clinical Science Building
627 Rode Rd
Chermside QLD 4032
QLD
Country 99691 0
Australia
Phone 99691 0
+61 0421273217
Fax 99691 0
Email 99691 0
[email protected]
Contact person for scientific queries
Name 99692 0
A/Prof Gianluigi Li Bassi
Address 99692 0
Critical Care Research Group
The Prince Charles Hospital
Clinical Science Building
627 Rode Rd
Chermside QLD 4032
QLD
Country 99692 0
Australia
Phone 99692 0
+61 0421273217
Fax 99692 0
Email 99692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual non-identifiable participant data collected during the study will be available
When will data be available (start and end dates)?
31/05/2020

In addition IPD will be kept and made available for 5 years
Available to whom?
Other scientific societies and researchers
Available for what types of analyses?
Only to achieve the aims in the approved proposal made by the potential collaborative society/researcher
How or where can data be obtained?
By emailing the principal investigator:
Gianluigi Li Bassi, MD, PhD
[email protected]


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
EmbaseImpact of renin-angiotensin-aldosterone system inhibition on mortality in critically ill COVID-19 patients with pre-existing hypertension: a prospective cohort study.2022https://dx.doi.org/10.1186/s12872-022-02565-1
EmbaseHemorrhage, Disseminated Intravascular Coagulopathy, and Thrombosis Complications among Critically Ill Patients with COVID-19: An International COVID-19 Critical Care Consortium Study*.2023https://dx.doi.org/10.1097/CCM.0000000000005798
EmbaseCerebrovascular Complications of COVID-19 on Venovenous Extracorporeal Membrane Oxygenation.2023https://dx.doi.org/10.1097/CCM.0000000000005861
EmbaseNeurological Manifestations of SARS-CoV-2 Infection: Protocol for a Sub-analysis of the COVID-19 Critical Care Consortium Observational Study.2022https://dx.doi.org/10.3389/fmed.2022.930217
Dimensions AIDesign and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study2020https://doi.org/10.1136/bmjopen-2020-041417
Dimensions AIVariability of oxygen requirements in critically ill COVID-19 patients2024https://doi.org/10.7189/jogh.14.05012
Dimensions AIAn appraisal of respiratory system compliance in mechanically ventilated covid-19 patients2021https://doi.org/10.1186/s13054-021-03518-4
N.B. These documents automatically identified may not have been verified by the study sponsor.