Table 1 Key trial design elements for ASCOT ADAPT
Core primary outcome measure | Death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support in the 28 days after randomisation |
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Core secondary outcome measures | 1. Time to clinical recovery during the first 28 days after randomisation 2. WHO 8-point ordinal outcome scale at day 28 post randomisation 3. All-cause mortality at 28 and 90 days post randomisation 4. Days alive and free of hospital by 28 days post randomisation 5. Days alive and free of ventilation by 28 days post randomisation 6. Presence of patient reported outcome of shortness of breath at days 28 and 90 post randomisation 7. Quality of life as measured by EQ5D5L questionnaire at days 28 and 90 post randomisation |
Study domains | 1. Antiviral domain 2. Therapeutic antibody domain 3. Anticoagulation domain 4. Other domain (to be determined) |
Platform inclusion criteria | 1. Age ≥ 18 years 2. Admitted to an acute-care hospital 3. Confirmed SARS-CoV-2 by nucleic acid testing in the 14 days prior to randomisation 4. Able to be randomised within 14 days of symptom onset 5. At least one symptom or sign attributable to SARS-CoV-2 infection |
Platform exclusion criteria | 1. Currently receiving acute intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support 2. Previous participation in the trial 3. Treating team deems enrolment in the study is not in the best interest of the patient 4. Death is deemed to be imminent and inevitable within the next 24 h 5. Either the patient or their primary treating clinician are not committed to active treatment |