Status:
ACTIVE_NOT_RECRUITING
Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
The Peter Doherty Institute for Infection and Immunity
Australasian Society for Infectious Diseases
Conditions:
SARS-CoV-2 Infection (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection (COVID-19).
Detailed Description
ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled, Bayesian, adaptive platform trial. The objective of ASCOT is to identify the regimen (combination of interventions)...
Eligibility Criteria
Inclusion
- A.Core Platform (all participants must meet the following):
- 1\. Adult (as defined by local jurisdiction) patient admitted to hospital with acute illness and suspected or proven SARS-CoV-2 infection.
- B. Antiviral II Domain (all participants in the Antiviral II domain must meet the following):
- 1\. SARS-CoV-2 infection has been confirmed by positive rapid antigen test OR polymerase chain reaction test within the last 7 days
Exclusion
- A. Core platform exclusions (all participants must not meet the following):
- Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
- Patient is expected to be discharged from hospital today or tomorrow
- More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to proven SARS-CoV-2 infection
- Previous participation in this trial, or another trial that is analysed within the same statistical model as this trial, within the last 90 days
- B. Antiviral II Domain exclusions (patients at sites participating in the Antiviral II Domain must not meet the following):
- Severe renal impairment, defined as eGFR\<30ml/min or receipt of renal replacement therapy
- Severe hepatic impairment, defined as proven or suspected cirrhosis with Child Pugh class of C, OR acute hepatitis, defined as AST or ALT\>5 times the upper limit of normal in the testing laboratory.
- The patient has received, at the time of eligibility assessment, \>24h of an antiviral agent intended to have activity against SARS-CoV-2, within the past 7 days
- The patient is known to be pregnant or breastfeeding
- The treating clinician believes that participation in the domain would not be in the best interests of the patient
- B.1. Antiviral II Domain Non-Immune Suppressed Stratum-specific Exclusion Criteria (all non-immune suppressed patients at sites participating in the Antiviral II Domain must not meet the following):
- 1\. Onset of COVID-related symptoms was more than 7 days (i.e., 168 hours) ago
- B2. Antiviral II domain Intervention-specific Exclusion Criteria (All patients at sites participating in the Antiviral II Domain will be excluded from the below interventions if they meet the following):
- Will be excluded from receiving Remdesivir if:
- No venous access is available and none can be created
- Known hypersensitivity to remdesivir or its excipients
- Will be excluded from receiving Nirmatrelvir/ritonavir if:
- The patient is unable to take, tolerate or absorb oral or enteral medications
- Known hypersensitivity to any of nirmatrelvir, ritonavir or its excipients
- Receipt of a concomitant drug with a high-risk interaction with nirmatrelvir-ritonavir which cannot be ceased or substituted.
- Will be excluded from receiving no antiviral agent if:
- The patient is in the Immune Suppressed Stratum
- The patient is receiving or has received supplemental oxygen on the calendar day of eligibility assessment.
- The patient is considered by the treating clinician to be at very high risk for progression to severe COVID-19
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT04483960
Start Date
July 28 2020
End Date
December 31 2025
Last Update
May 16 2024
Active Locations (25)
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1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
2
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
3
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
4
Nepean Hospital
Kingswood, New South Wales, Australia, 2747