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ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial.
Denholm, Justin T; Venkatesh, Balasubramanian; Davis, Joshua; Bowen, Asha C; Hammond, Naomi E; Jha, Vivekanand; McPhee, Grace; McQuilten, Zoe; O'Sullivan, Matthew V N; Paterson, David; Price, David; Rees, Megan; Roberts, Jason; Jones, Mark; Totterdell, James; Snelling, Thomas; Trask, Nanette; Morpeth, Susan; Tong, Steven Yc.
  • Denholm JT; Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
  • Venkatesh B; Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, 3000, Australia.
  • Davis J; The George Institute for Global Health, Sydney, Australia.
  • Bowen AC; The George Institute for Global Health, New Delhi, India.
  • Hammond NE; Faculty of Medicine, University of New South Wales, Sydney, Australia.
  • Jha V; Menzies School of Health Research, Charles Darwin University, Darwin, Australia.
  • McPhee G; Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW, Australia.
  • McQuilten Z; Menzies School of Health Research, Charles Darwin University, Darwin, Australia.
  • O'Sullivan MVN; Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia.
  • Paterson D; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Australia.
  • Price D; The George Institute for Global Health, Sydney, Australia.
  • Rees M; Faculty of Medicine, University of New South Wales, Sydney, Australia.
  • Roberts J; The George Institute for Global Health, New Delhi, India.
  • Jones M; Faculty of Medicine, University of New South Wales, Sydney, Australia.
  • Totterdell J; Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, 3000, Australia.
  • Snelling T; Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University, Melbourne, Australia.
  • Trask N; Transfusion Research Unit, Monash University, Melbourne, Australia.
  • Morpeth S; Department of Infectious Diseases Westmead Hospital, Westmead, Australia.
  • Tong SY; NSW Health Pathology, Institute for Clinical Pathology and Medical Research, Westmead, Australia.
Trials ; 23(1): 1014, 2022 Dec 14.
Article in English | MEDLINE | ID: covidwho-2162410
ABSTRACT

BACKGROUND:

SARS-CoV-2 infection is associated with a significant risk of hospitalisation, death, and prolonged impact on quality of life. Evaluation of new treatment options and optimising therapeutic management of people hospitalised with SARS-CoV-2 infection remains essential, but rapid changes in pandemic conditions and potential therapies have limited the utility of traditional approaches to randomised controlled trials.

METHODS:

ASCOT ADAPT is an international, investigator-initiated, adaptive platform, randomised controlled trial of therapeutics for non-critically ill patients hospitalised with COVID-19. The study design is open label and pragmatic. Potential participants are hospitalised adults with PCR confirmed, symptomatic, SARS-CoV-2 infection, within 14 days of symptom onset. Domains include antiviral, antibody and anticoagulant interventions, with a composite primary outcome of 28-day mortality or progression to intensive-care level respiratory or haemodynamic support. Initial interventions include intravenous nafamostat and variable dose anticoagulation. A range of secondary endpoints, and substudies for specific domains and interventions are outlined.

DISCUSSION:

This paper presents the trial protocol and management structure, including international governance, remote site monitoring and biobanking activities and provides commentary on ethical and pragmatic considerations in establishing the ASCOT ADAPT trial under pandemic conditions. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry (ACTRN12620000445976) and ClinicalTrials.gov (NCT04483960).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Humans Country/Region as subject: Oceania Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06929-y

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Humans Country/Region as subject: Oceania Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06929-y