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
Justin T Denholm, Joshua Davis, David Paterson, Jason Roberts, Susan Morpeth, Thomas Snelling, Dominica Zentner, Megan Rees, Matthew O'Sullivan, David Price, Asha Bowen, Steven YC Tong
Trials | BMC | Published : 2020
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..View full abstract
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.