ASCOT closes the Antiviral Treatment Domain
On Thursday, 11 August 2022, the ASCOT Trial Steering Committee (TSC), with support from the Antiviral Domain-Specific Working Group (DSWG), made the decision to close the Antiviral Treatment Domain. The Domain was officially switched off on the study database at 4:00PM AEST on Friday, 12 August 2022. At the time of this decision, there was a total of 159 participants enrolled in the Antiviral Domain worldwide.
The rationale for this decision is due to the feasibility of continuing the domain. We are seeing a much slower recruitment rate with a highly vaccinated population and less severe variant, that is resulting in less people being admitted to hospital for COVID pneumonitis. Patients who are currently being admitted tend to have other health conditions that are exacerbated by COVID and are generally inappropriate to be enrolled into the Antiviral Domain. For this reason, we are unlikely to reach a sample size that would meet a statistical trigger in a timely manner. The data from this domain is also becoming less relevant as the current patient population are primarily infected with Omicron, which differs from the patients randomised at the start of the trial, who were primary infected with Delta.
Reaching this milestone would not have been possible without the joint effort of all ASCOT sites and collaborators, across Australia, NZ and Nepal. We would like to especially thank the members of the Antiviral DSWG, who have provided their expertise and time toward developing this domain and CKD Pharmaceuticals and Institute Pasteur Korea, who provided advice, support and supply of the study drug across each region.
We look forward to reporting the results and contributing a final analysis of the effect of antiviral treatment with nafamostat for patients with COVID-19. We hope the results from this domain will also contribute to meta-analyses and be pooled with other international clinical trials examining the effects of nafamostat and other TMPRSS2 inhibitors for patients with COVID-19.
The closure of this domain means there are currently no active domains in ASCOT. The study will go on hold at all ASCOT sites until we add new domains that are currently under discussion and being protocolised.