Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (ASCOT ADAPT)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    2400
  • sponsor
    University of Melbourne
Updated on 4 October 2022

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).

Description

ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled adaptive platform 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.

Platform trials allow multiple questions to be evaluated simultaneously and sequentially within the platform, and evaluate interaction between different treatment options, to achieve the goal of determining the optimal combination of treatments for the disease as rapidly as possible. The overarching objective of ASCOT-ADAPT is to identify the regimen (combination of interventions) associated with the highest chance of survival free of advanced respiratory support or vasopressor / inotropic support at 28 days after randomisation, in adults hospitalised with COVID-19 but not requiring ICU-level care at baseline.

In the initial implementation of the adaptive platform, recruiting sites have the option to participate in one or more of three treatment domains. Consented participants will then be able to choose whether to be enrolled into one or more available domains concurrently. Participants will then be randomised to the corresponding interventions:

Intervention domain A (antiviral):

Participants will be randomised using response adaptive randomisation (RAR) on day 1 to receive either i) standard of care without nafamostat; or ii) standard of care with nafamostat

(Domain Closed) Intervention domain B (antibody): Participants will be randomised using response adaptive randomisation (RAR) on day 1 to receive either i) standard of care without hyperimmune globulin; or ii) standard of care with hyperimmune globulin

(Domain Closed) Intervention domain C (anticoagulation): Participants will be randomised using response adaptive randomisation (RAR) on day 1 to receive either i) standard dose thromboprophylaxis; or ii) intermediate dose thromboprophylaxis; or iii) therapeutic anticoagulation

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. Participants will be followed up at Day 90.

Details
Condition SARS-CoV-2 Infection (COVID-19)
Treatment Aspirin, Enoxaparin, dalteparin, hydroxychloroquine, Tinzaparin, Convalescent plasma, Nafamostat Mesilate, Lopinavir / Ritonavir, Hyperimmune Globulin
Clinical Study IdentifierNCT04483960
SponsorUniversity of Melbourne
Last Modified on4 October 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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