ASCOT - The Australasian COVID-19 Trial

The AustralaSian COVID-19 Trial, is a multi-centre randomised adaptive platform clinical trial to assess clinical, virological, and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19). The overall sponsor of the study is the University of Melbourne, but the New Zealand arm of the study is funded by the Health Research Council, and led by clinical microbiologist and infectious disease consultant, Dr Susan Morpeth. The adaptive platform design allows investigators to test a variety of potential treatments for patients hospitalised with COVID-19, but do not require intensive care. 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. In New Zealand, the currently open interventions are trialling Nafamostat (antiviral) and different thromboprophylactic doses (anticoagulation).  Participants can be randomised to more than one domain if they meet eligibility criteria. Participation in ASCOT is open to adults hospitalised due to COVID-19 within 14 days of symptom onset.  Notably, pregnant women are eligible to participate in both the antibody and anticoagulation domains. ASCOT is actively recruiting at 30 sites across New Zealand, Australia, and India. To date, across all sites, 965 individuals have been enrolled in this trial. There are currently seven hospitals participating in New Zealand, of which 2 are actively recruiting.