GENERATING ROBUST CLINICAL EVIDENCE ON COVID-19 TREATMENT VIA THE ASCOT TRIAL

 

THE ASCOT TRIAL

ASCOT is a clinical trial that will generate clinical evidence about treatment for COVID-19 that can be applied during the pandemic to reduce mortality or the need for mechanical ventilation in hospitalised but not yet critically ill patients with COVID-19. Consenting participants will be randomised to either lopinavir-ritonavir (an anti-viral used to treat HIV), hydroxychloroquine (used in autoimmune diseases), both of these agents in combination, or the current standard of care.

LATEST NEWS

Awards & Accolades: ASCOT Trial - Winner of Excellence in Trials Statistics Award Winner at the 2023 ACTA Clinical Trials Symposium.

REPORT

Primary Outcome: To determine if either or both of these potential treatments will reduce the risk of needing intensive care or death from pandemic coronavirus infection.

CASE STUDY

“Australasian COVID-19 Trial (ASCOT) reached an important milestone on Tuesday, 21 September 2021, randomising the 1,000th patient into the study.”

BACKGROUND

  • The SARS-CoV-2 virus causes the disease COVID-19. The number of people infected is rapidly increasing and many are needing hospitalisation, some require mechanical assistance with breathing (mechanical ventilation).

  • ASCOT is a clinical trial that will generate clinical evidence about treatment for COVID-19 that can be applied during the pandemic to reduce mortality or the need for mechanical ventilation in hospitalised but not yet critically ill patients with COVID-19.

  • The trial aims to generate results quickly. After the trial begins, results will be continually analysed, so that ineffective therapies can be stopped, and new therapies can be evaluated as part of the trial.

TRIAL DESIGN

  • A multi-centre randomised adaptive platform clinical trial to assess clinical, virological, and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19).

  • 1161 patients enrolled in trial. 1161 patients randomised. 35 sites activated.

  • It offers greater flexibility than a traditional fixed clinical trial design as it uses outcome data as it is accumulated to modify the course of the trial.

  • This trial design is highly relevant as the COVID-19 pandemic continues to evolve, and international research continues to update our current understanding of possible treatments.

  • The ASCOT ADAPT protocol has 3 treatment domains: antiviral, antibody and anticoagulation.

  • Participants can be randomised to more than one domain if they meet eligibility criteria.

KEY CONNECTIONS

  • Coordinating Principal Investigator, Steven Tong. Associate Professor, The Doherty Institute.

  • Coordinating Principal Investigator, Josh Davis. Professor, Menzies School of Health Research.

  • Trial Manager, Grace McPhee. Senior Clinical Trial Coordinator, The Doherty Institute.

  • EDC Platform Project Manager, Emma Winks. Project Manager, Spiral.

  • Our Spiral Project Lead and EDC Platform manager for the ASCOT study is Emma Winks

    As a Project Manager at Spiral, Emma oversees software development used in clinical trials. She is used to working with lots of moving parts with a laser-beam focus.

  • “It is an incredibly agile environment. Whatever comes my way - I jump on it and deal with it”

    MEET EMMA