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%. Few therapeutics have been shown to be of benefit in treating COVID-19, and providing patients supportive care – providing oxygen, treating other medical conditions, and mechanical ventilation when needed, is currently a key part of treating COVID-19. Dexamethasone, a steroid medication, and an antiviral call remdesivir, have been demonstrated to be beneficial for some patients.
The trial will investigate different types of treatments:
- Antiviral therapies, which aim to limit the virus replicating
- Therapeutic antibody treatment, which uses antibodies from people who have recovered from COVID-19
The Need To Test In Clinical Trials
At this stage, there are few specific therapies that have 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 antiviral therapies like those that will be tested in the trial. 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.
ASCOT has been endorsed by the Thoracic Society of Australia and New Zealand (TSANZ) and the Australasian Society for Infectious Diseases (ASID). TSANZ is the peak body for respiratory physicians and is a health promotion charity. ASID is the peak professional body for infectious diseases and microbiology.