No. The COVID-19 Critical Care Consortium Incorporating ECMOCARD Study does not only include ECMO patients. It includes all COVID-19 patients in the ICU, even those which do not receive mechanical ventilation or ECMO.

The ECMOCARD study team will send you a starting package containing the study protocol, data collection form and an ethics approval request template letter. Study documents are also available here. These documents can be submitted to your Institutional Review Board (IRB)/Ethics Committee (EC) for approval to participate in the combined study. It is the responsibility of the participating hospital to obtain all ethical and regulatory approvals required by your site to participate in this study. Once all necessary approvals are obtained at your site, email them to ECMOCARD@health.qld.gov.au and the study team will forward further instructions.

The ECMOCARD study team will send you the combined study protocol and data collection form which will supersede the ISARIC documents previously submitted to your IRB/EC. We will also send an ethics amendment request template letter, which explains the addition of ECMOCARD to the ISARIC nCoV protocol. These documents are also available here. Once the amendment has been approved at your site and all approvals are in place, email your IRB/ethics approval letter and data sharing agreement (if applicable. See Question 6 below) to ECMOCARD@health.qld.gov.au. We will forward further instructions regarding database access.

This will be determined by the requirements of each hospital site’s IRB/EC. Given that this study is gathering data which is already collected as part of standard care, and that all data leaving your hospital will be de-identified, we think that a waiver of patient consent should be considered by the IRB/EC. Participation in this study will pose negligible risk to the patient.

Only if your institution requires one. If your site does need a contract, our preferred option is the ISARIC Data Sharing Agreement. If the ISARIC agreement does meet your site’s requirements, the study Sponsor, ELSO, has provided an alternate agreement template.

No. Participation in the sub-studies is optional. If your site would like to participate in a sub-study, please email your IRB/EC approval for Protocol version 1.2.8 to ECMOCARD@health.qld.gov.au and let the team know which sub-study you would like to participate in. After your approval letter has been received by the team, we will be in touch regarding access to the sub-study CRF in REDCap database as this is a separate database to the joint ISARIC nCoV-ECMOCARD database.

We have developed a database which is hosted by Oxford University, United Kingdom, so that all SPRINT SARI and ECMOCARD data can be entered seamlessly into one single database, called nCov_EOT. If you already have ISARIC_nCoV database access (SPRINT SARI), the nCoV_EOT login will replace this. Do not enter data into both databases.

Once all ethical and regulatory approvals are received by the study coordinators, a site-specific login/s will be provided. Only fully anonymised and de-identified data will be entered by the participating sites.

Once you have received all necessary ethical and regulatory approvals at your site, you can immediately commence data collection using the integrated ISARIC nCoV and ECMOCARD paper data form and data dictionary provided. Once you are supplied with your site-specific login/s for the REDCap database, you can enter data directly into the database.

The REDCap Database Coordinator can deal with technical issues you are experiencing with the database such as not being able access or login to the database. A REDCap CRF data completion guide will be provided to you at the time your REDCap logins are generated. In case of specific issues with the ECMOCARD content on the database you should contact Associate Professor Gianluigi Li Bassi.

Clinical investigators contributing to the research efforts will be given full recognition for their efforts and will be given the opportunity to access data. Ownership of any data transferred to the REDCap eCRF will be retained by the site that contributed it. Authorship of any manuscripts arising from the data will be determined according to the internationally agreed criteria for authorship. Authorship of parallel studies conducted outside of the main trial will be according to the individuals involved in the study but must acknowledge the contribution of the involved investigators.

For resolution of a clinical query regarding the study, firstly refer to your Principal Investigator and, if still unresolved, the Chief Investigator, Gianluigi Li Bassi, or ECMOCARD@health.qld.gov.au.

The ECMOCARD project team will liaise with each participating region to identify an individual who will lead the project for that region. The regional lead/s is responsible for:

1. Identifying the investigator at participating sites

2. Ensuring distribution of study materials (as required)

3. Researching the country’s ethical regulatory requirements and ensuring each site is adhering to ethical requirements

4. Communicating with sites within their nation

5. Communicating with the management committee.

The regional co-ordinator will be the primary contact for each site within the country and/or region.

The Principal Investigator at your hospital agrees to:

1. Perform the study in accordance with the study protocol, ICH guidelines for GCP and the applicable regulatory requirements.

2. Produce progress reports, and any other required documentation required by the local IRB/EC.

3. Maintain records of study correspondence and applicable documentation as required by the local IRB/EC.

4. Be responsible for the maintenance of a securely held enrolment log linking the patient hospital record number and the ECMOCARD study number.

5. Provide reliable data and all information requested by the study protocol in an accurate and legible manner according to the instructions provided.