Last updated on July 2020

Australasian COVID-19 Trial (ASCOT)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: SARS-CoV-2 Infection (COVID-19)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 18 years
  2. Confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days
  3. Able to be randomised within 12 days of symptom onset
  4. Expected to be remain an inpatient for at least 48 hours from the time of randomisation

Exclusion Criteria:

  1. Overall exclusions:
  2. 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.
  3. Previous participation in the trial;
  4. Known pregnancy;
  5. Treating team deems enrolment in the study is not in the best interests of the patient;
  6. Death is deemed to be imminent and inevitable within the next 24 hours;
  7. Enrolment to other study protocols that do not allow co-enrolment in ASCOT.
  8. Domain 1 (Antiviral) specific exclusions:
  9. LPV/r not available at trial site;
  10. Hydroxychloroquine not available at trial site;
  11. Currently taking LPV/r OR hydroxychloroquine;
  12. Known allergy or hypersensitivity to LPV/r OR hydroxychloroquine
  13. Use of medications that are contraindicated with LPV/r OR hydroxychloroquine that cannot be replaced or stopped during the study period;
  14. Known cirrhosis or ALT or AST > 5x upper limit of normal;
  15. Known HIV infection not on antiretroviral therapy;
  16. QTc 470ms for males, QTc 480ms for females;
  17. Treating team deems enrolment in antiviral interventions is not in the best interests of the patient.
  18. Domain 2 (Convalescent Plasma) specific exclusions:
  19. Convalescent plasma not available at trial site;
  20. Participant has already received treatment with non-trial prescribed SARS-CoV-2-specific immunoglobulin therapy (convalescent plasma, hyperimmune globulin or monoclonal antibody);
  21. Known previous history of transfusion-related acute lung injury;
  22. Know previous history of serious allergic reaction to blood product transfusion;
  23. Known religious objection to receiving blood products;
  24. Treating team deems enrolment in antibody interventions is not in the best interests of the patient.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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