The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial

JT Denholm; J Davis; D Paterson; J Roberts; S Morpeth; T Snelling; D Zentner; M Rees; M O'Sullivan; D Price; A Bowen; SYC Tong; S Anderson; Z McQuilton; B Venkatesh; N Hammond; V Jha; VJ Burston; J McMahon; P Charles; R Commons; D O'Brien; A Mahoney; D Sheffield; LL Lim; B Gardiner; T Schulz; J Torresi; R Chean; J Sasadeusz; B Rogers; C Aboltins; K Singh; M Yong; D Lister; K Visvanathan; J Molton; A Tai; R Chalmers; M Martinello; P Wilson; T Gray; S Coghill; H Foo; A Sud; J Williams; N Lwin; J Post; S Van Haal; R Sullivan; G Matthews; BCH Kwan; A Slack; O Shum; B Cochrane; R Dotel; T Gilbey; M Mina; Y Su; C Trethewy; B Hudson; A Chatterji; C Mostert; D New; E Raby; S Hui; O Robinson; J Hart; SJ Tan; A Arellano; J Chambers; J Davis; N Rafiei; S Smith; M Sehu; J Da Silva; P Griffin; A Henderson; K Chaw; K Choong; A Burke; C Heather; S Senanayake; M Boyd; E Rowe; M Anagnostou; A Trad; A Ratcliff; J Dummer; H Bhally; M Giola; K Grimwade; CLL Chang; A Verrall; S Hogg; D Restropo; M Maze; S Ritchie; C Gedye; J Chang

Journal article

The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial

JT Denholm, J Davis, D Paterson, J Roberts, S Morpeth, T Snelling, D Zentner, M Rees, M O'Sullivan, D Price, A Bowen, SYC Tong, S Anderson, Z McQuilton, B Venkatesh, N Hammond, V Jha, VJ Burston, J McMahon, P Charles Show all

Trials | BMC | Published : 2020

DOI: 10.1186/s13063-020-04576-9

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Abstract

Objectives: To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection. Trial design: ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management. Participants: Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolita..

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University of Melbourne Researchers

Justin Denholm Author

Jason Roberts Author

Dominica Zentner Author

Megan Rees Author

Grants

Funding Acknowledgements

ASCOT has been initially funded in Australia by a variety of philanthropic donors, and in New Zealand by the Health Research Council, who have no role in study design, analysis and decision to publish.