Last updated on July 2020

Australasian COVID-19 Trial (ASCOT)

Brief description of study

An International Multi-Centre Randomised Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients Diagnosed with SARS-CoV-2 Infection (COVID-19).

Detailed Study Description

ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. The study design will allow harmonisation with existing frameworks such as the Sentinel Travellers Research Preparedness Platform for Emerging Infectious Diseases (SETREP-ID) and the Randomised, embedded, multifactorial adaptive platform trial for community acquired pneumonia (REMAP-CAP) study.

As it is too early to accurately predict the size and distribution of the SARS-CoV-2 epidemic the feasibility and sample size requirements of the study will be progressively considered. In the initial design, recruiting sites have the option to participate in either one treatment domain or both treatment domains. Consented participants will then be able to choose whether to be enrolled into either or both treatment domains concurrently. Participants will then be randomised to the corresponding interventions:

Intervention domain 1 (antiviral):

Participants will be randomised 1:1:1 on day 1 to receive either i) standard of care without LPV/r or hydroxychloroquine; or ii) LPV/r alone; or iii) LPV/r plus hydroxychloroquine.

Intervention domain 2 (antibody):

Participants will be randomised 1:1 on day 1 to receive either i) standard of care without convalescent plasma; or ii) convalescent plasma

Daily data will be collected for the first 28 days or until discharge, whichever is earlier. There will be a core dataset collected for all patients at all sites and enhanced and research data and biological samples for sites with capacity. As long as the participant remains an inpatient, their medical records will be reviewed weekly until discharge or the 90-day time point, whichever occurs first.

Clinical Study Identifier: NCT04483960

Find a site near you

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Armidale Hospital

Armidale, Australia
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Blacktown Hospital

Blacktown, Australia
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Campbelltown Hospital

Campbelltown, Australia
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Northern Beaches Hospital

Frenchs Forest, Australia
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Nepean Hospital

Kingswood, Australia
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Liverpool Hospital

Liverpool, Australia
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John Hunter Hospital

New Lambton Heights, Australia
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The Tweed Hospital

Tweed Heads, Australia
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Westmead Hospital

Westmead, Australia
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Wollongong Hospital

Wollongong, Australia
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Caboolture Hospital

Caboolture, Australia
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Cairns Hospital

Cairns, Australia
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Logan Hospital

Meadowbrook, Australia
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Redcliffe Hospital

Redcliffe, Australia
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South Brisbane, Australia
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Flinders Medical Centre

Bedford Park, Australia
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Lyell McEwin Hospital

Elizabeth Vale, Australia
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Ballarat Health Services

Ballarat Central, Australia
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Bendigo Health

Bendigo, Australia
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Monash Health

Clayton, Australia
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Northern Health

Epping, Australia
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Austin Health

Heidelberg, Australia
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Cabrini Health

Malvern, Australia
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Alfred Hospital

Melbourne, Australia
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Epworth Richmond

Richmond, Australia
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Western Health

St Albans, Australia
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Armadale Health Service

Mount Nasura, Australia
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Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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