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).
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.
|Treatment||hydroxychloroquine, Convalescent plasma, Lopinavir / Ritonavir|
|Clinical Study Identifier||NCT04483960|
|Sponsor||University of Melbourne|
|Last Modified on||30 November 2020|
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