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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

Denholm, J.T., Davis, J., Paterson, D., Roberts, J., Morpeth, S., Snelling, T., Zentner, D., Rees, M., O’Sullivan, M., Price, D., Bowen, A., Tong, S.Y.C., Davis, J., Anderson, S., McQuilton, Z., Venkatesh, B., Hammond, N., Jha, V., Burston, V.J., McMahon, J., Charles, P., Commons, R., O’Brien, D., Mahoney, A., Sheffield, D., Lim, L-L, Gardiner, B., Schulz, T., Torresi, J., Chean, R., Sasadeusz, J., Rogers, B., Aboltins, C., Singh, K., Yong, M., Lister, D., Visvanathan, K., Molton, J., Tai, A., Chalmers, R., Martinello, M., Wilson, P., Gray, T., Coghill, S., Foo, H., Sud, A., Williams, J., Lwin, N., Post, J., van Haal, S., Sullivan, R., Matthews, G., Kwan, B.C.H., Slack, A., Shum, O., Cochrane, B., Dotel, R., Gray, T., Gilbey, T., Mina, M., Su, Y., Trethewy, C., Hudson, B., Chatterji, A., Mostert, C., New, D., Raby, E., Hui, S., Robinson, O., Hart, J., Tan, S.J., Arellano, A., Chambers, J., Davis, J., Rafiei, N., Smith, S., Sehu, M., da Silva, J., Griffin, P., Henderson, A., Chaw, K., Choong, K., Burke, A., Heather, C., Senanayake, S., Boyd, M., Rowe, E., Anagnostou, M., Trad, A., Ratcliff, A., Morpeth, S., Dummer, J., Bhally, H., Giola, M., Grimwade, K., Chang, C.L-L, Verrall, A., Hogg, S., Restropo, D., Maze, M., Ritchie, S., Gedye, C., Chang, J., Maze, M., Pillai, P., Flanagan, K., Mora, J., Post, J., Lam, E., Littleford, R., Knoblauch, N. and Slow, S. (2020) 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. Trials, 21 (1). Art. 646.

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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 metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently.

Item Type: Journal Article
Murdoch Affiliation(s): School of Veterinary and Life Sciences
Publisher: BioMed Central
Copyright: © 2020 The Authors.
Other Information: Courtesy of the ASCOT Investigator Group
URI: http://researchrepository.murdoch.edu.au/id/eprint/61667
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