Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study

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Author(s)
Li Bassi, G
Suen, J
Barnett, AG
Corley, A
Millar, J
Fanning, J
Lye, I
Colombo, S
Wildi, K
Livingstone, S
Abbate, G
Hinton, S
Liquet, B
Shrapnel, S
Dalton, H
Fraser, JF
Griffith University Author(s)
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2020
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Abstract

INTRODUCTION: There is a paucity of data that can be used to guide the management of critically ill patients with COVID-19. In response, a research and data-sharing collaborative-The COVID-19 Critical Care Consortium-has been assembled to harness the cumulative experience of intensive care units (ICUs) worldwide. The resulting observational study provides a platform to rapidly disseminate detailed data and insights crucial to improving outcomes. METHODS AND ANALYSIS: This is an international, multicentre, observational study of patients with confirmed or suspected SARS-CoV-2 infection admitted to ICUs. This is an evolving, open-ended study that commenced on 1 January 2020 and currently includes >350 sites in over 48 countries. The study enrols patients at the time of ICU admission and follows them to the time of death, hospital discharge or 28 days post-ICU admission, whichever occurs last. Key data, collected via an electronic case report form devised in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium/Short Period Incidence Study of Severe Acute Respiratory Illness networks, include: patient demographic data and risk factors, clinical features, severity of illness and respiratory failure, need for non-invasive and/or mechanical ventilation and/or extracorporeal membrane oxygenation and associated complications, as well as data on adjunctive therapies. ETHICS AND DISSEMINATION: Local principal investigators will ensure that the study adheres to all relevant national regulations, and that the necessary approvals are in place before a site may contribute data. In jurisdictions where a waiver of consent is deemed insufficient, prospective, representative or retrospective consent will be obtained, as appropriate. A web-based dashboard has been developed to provide relevant data and descriptive statistics to international collaborators in real-time. It is anticipated that, following study completion, all de-identified data will be made open access.

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BMJ open

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10

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12

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© Author(s) (or their employer(s)) 2020. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Clinical sciences

Health services and systems

Public health

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epidemiology

intensive & critical care

respiratory infections

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Li Bassi, G; Suen, J; Barnett, AG; Corley, A; Millar, J; Fanning, J; Lye, I; Colombo, S; Wildi, K; Livingstone, S; Abbate, G; Hinton, S; Liquet, B; Shrapnel, S; Dalton, H; Fraser, JF, Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study, BMJ open, 2020, 10 (12), pp. e041417

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