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.
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) and the case fatality rate is around 1%. The mainstay of management is supportive care – providing oxygen, treating other medical conditions, and mechanical ventilation when needed.
There are currently no specific therapies for COVID-19. The two main strategies are to limit the virus replicating (antiviral therapies) or to modulate the immune response (in some severe cases, there is a damaging over exuberant immune response).
Antiviral therapies that have shown promise in the laboratory include an HIV medication called lopinavir-ritonavir and an anti-malarial medication called hydroxychloroquine. A novel antiviral called remdesivir is under investigation in trials outside of Australia and NZ.
The Need To Test In Clinical Trials
At this stage, no specific therapy has been shown to improve clinical outcomes in patients with COVID-19. By clinical outcomes we mean things like dying, or requiring mechanical ventilation, or the length of hospitalisation. Things that matter to patients.
Promising therapies in the laboratory do not always translate to improved clinical outcomes.
There are many examples of this in cancer therapies but also drugs such as hydroxychloroquine for viral infections. Promising therapies may actually be harmful in some cases.
The best way to determine whether a promising therapy actually improves clinical outcomes is to perform a clinical trial. In a clinical trial patients are randomly allocated to different therapies (in some case to no specific therapy – this is the standard of care). We can then objectively assess whether patients who received a specific therapy fare better, worse or the same compared to patients who received a different therapy or standard of care. This is the most rigorous way to demonstrate the benefits or harms of therapies.
ASCOT intends to randomise patients to different therapies to understand their impact on clinical outcomes. We will do this for existing therapies, but also be set-up to test new and emerging therapies as they become available.