Australasian COVID-19 Trial (ASCOT): 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)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    2400
  • sponsor
    University of Melbourne
Updated on 30 November 2020

Summary

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).

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.

Details
Treatment hydroxychloroquine, Convalescent plasma, Lopinavir / Ritonavir
Clinical Study IdentifierNCT04483960
SponsorUniversity of Melbourne
Last Modified on30 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have SARS-CoV-2 Infection (COVID-19)?
Do you have any of these conditions: Do you have SARS-CoV-2 Infection (COVID-19)??
Do you have any of these conditions: Do you have SARS-CoV-2 Infection (COVID-19)??
Age 18 years
Confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days
Able to be randomised within 12 days of symptom onset
Expected to be remain an inpatient for at least 48 hours from the time of randomisation

Exclusion Criteria

Overall exclusions
Currently receiving acute intensive respiratory support (invasive or noninvasive ventilation) or vasopressor/inotropic support. Note, participants already on non-invasive ventilation (either CPAP or BiPAP) in the community can still be recruited if they are continuing on their usual degree of NIV. Humidified high flow nasal oxygen will not be considered an exclusion criterion
Previous participation in the trial
Known pregnancy
Treating team deems enrolment in the study is not in the best interests of the patient
Death is deemed to be imminent and inevitable within the next 24 hours
Enrolment to other study protocols that do not allow co-enrolment in ASCOT
Domain 1 (Antiviral) specific exclusions
LPV/r not available at trial site
Hydroxychloroquine not available at trial site
Currently taking LPV/r OR hydroxychloroquine
Known allergy or hypersensitivity to LPV/r OR hydroxychloroquine
Use of medications that are contraindicated with LPV/r OR hydroxychloroquine that cannot be replaced or stopped during the study period
Known cirrhosis or ALT or AST > 5x upper limit of normal
Known HIV infection not on antiretroviral therapy
QTc 470ms for males, QTc 480ms for females
Treating team deems enrolment in antiviral interventions is not in the best interests of the patient
Domain 2 (Convalescent Plasma) specific exclusions
Convalescent plasma not available at trial site
Participant has already received treatment with non-trial prescribed SARS-CoV-2-specific immunoglobulin therapy (convalescent plasma, hyperimmune globulin or monoclonal antibody)
Known previous history of transfusion-related acute lung injury
Know previous history of serious allergic reaction to blood product transfusion
Known religious objection to receiving blood products
Treating team deems enrolment in antibody interventions is not in the best interests of the patient
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