Participant Information
Why is the study happening?
Coronavirus (COVID-19) is an infectious disease caused by the Sars-CoV-2 virus.
Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment.
However, some will become seriously ill and require medical attention. For those people, the best treatment options are still unclear.
The ASCOT study aims to discover the most effective treatments for people in hospital with COVID-19.
Who is doing the study?
The ASCOT study has been led by researchers across Australia, New Zealand, India and Nepal and has the potential to include sites elsewhere in the world.
Currently, the ASCOT study is being conducted across Australia and New Zealand.
The lead sponsor for the study is The Peter Doherty Institute for Infection and Immunity (The Doherty Institute), University of Melbourne.
Each country conducting the study will have their own regional sponsor.
What happens if I agree to participate in this study?
You will be asked to give consent and sign a consent form. You will also be given a copy of the consent form to keep.
You will then be randomly allocated by a computer (like drawing straws) to one of the treatment groups.
The study will collect some information that is recorded as part of normal care – like medical history, temperature and oxygen levels and blood tests.
The study team will also follow up with you via telephone 180 days after you start the study, to determine how well you are recovering. If they can’t reach you, they will call your GP.
You do not have to pay anything to be in the study, nor will you be paid. All medications, tests, and medical care for the study will be free of charge.
If you agree to take part in ASCOT, you are free to withdraw at any time without giving a reason. This will not affect the care you receive.
Do I have to take part?
You do not have to take part.
This will not affect the quality of care you receive, and you will be given the standard treatments used at this hospital.
These treatments may be the same treatments you would have received in this study.
What treatments will be available in the study?
All patients will receive the best standard of care available at their hospital.
In addition, the ASCOT study will evaluate a range of treatment approaches against COVID-19.
There is currently one treatment approach being studied, which we refer to as a ‘domain’.
- Antiviral Domain – to stop the virus from multiplying.
- Remdesivir
- Paxlovid
- Remdesivir + Paxlovid
- No antiviral
Please see the Interventions page for more detailed information about these treatments.
What are the benefits of taking part?
This research will improve our knowledge of how to treat COVID-19 and may improve the care of patients with COVID-19 across the world.
Participants in the study may or may not benefit from the treatment they receive in this study.
What are the possible risks and disadvantages of taking part?
All medical treatments may cause side effects. You may experience no, some, or all side effects associated with the treatment(s) and they may be mild, moderate or severe.
Most side effects of these treatments are uncommon; however, your study doctor will monitor you closely at all times in case any occur.
Who do I call for information after I leave the hospital?
You will be given a participant card with the study team details to keep with you at all times, and you will be able to use the contact details to contact the study team at any time if you have any questions or concerns.
What do I do if I have a complaint?
If you have any complaints about the conduct of the study or any of the study team you have the right to make a complaint, this will not affect any care or treatment that you are receiving.
AUSTRALIA:
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Reviewing Human Research Ethics Committee: Sydney Local Health District (RPAH Zone) Contact Person Email: rosemary.carney@health.nsw.gov.au Position: Executive Officer Telephone: 02 9515 6766
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Sponsor: University of Melbourne Name: Office of Research Ethics and Integrity Email: research-integrity@unimelb.edu.au Website: https://research.unimelb.edu.au/work-with-us/ethics-and-integrity
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ASCOT Trial Management Group: Telephone: 03 8344 7739 Email: ascot-team@unimelb.edu.au
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Hospital Research Governance Office:
To be updated
NEW ZEALAND:
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Reviewing Human Research Ethics Committee: Northern B HDEC Email: hdecs@health.govt.nz
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Sponsor: Health Research Council of New Zealand Email: info@hrc.co.nz
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ASCOT New Zealand Trial Management Group: Aotearoa Clinical Trials
Email: grants@aotearoatrials.nz Website: https://www.aoteatoatrials.nz/
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