ASCOT Trial Dataset - hospitalised adults: primary and core secondary clinical outcomes(domain‑specific)

Full description

This dataset contains de‑identified participant‑level clinical data from the ASCOT adaptive platform trial for hospitalised adults with suspected or confirmed SARS‑CoV‑2 infection. It includes baseline demographics and comorbidities, randomisation allocation by domain and intervention received, daily in‑hospital clinical measures (organ‑support use, oxygen/ventilation status), key laboratory results where available (e.g. SARS‑CoV‑2 PCR/CT), and primary and core secondary outcomes. Primary outcome data are provided to day 21 post‑randomisation (hierarchical composite of in‑hospital mortality and duration of organ‑support); core secondary outcomes include WHO‑modified ordinal scale at day 14, all‑cause mortality at days 28/90/180, days alive and free of hospital/oxygen/ventilation to day 28, ICU admission and ICU outcomes (censored at 90 days), and patient‑reported measures (EQ‑5D‑5L and mMRC breathlessness where collected) at 180 days. From mid‑2026 the ASCOT ADAPT platform was extended to include an Anticoagulation domain that recruits a non‑COVID cohort of adults hospitalised with community‑acquired pneumonia (CAP). Data from this anticoagulation, non‑COVID CAP cohort will be incorporated into the ASCOT dataset and the HeSANDA record will be updated once those data become available. Sample size and timeframe Includes data for 1,650 participants enrolled between 28 July 2020 and 10 March 2026 (accrual to date). Final trial dataset will comprise up to 2,200 participants (target enrolment); additional participants from the mid‑2026 Anticoagulation (non‑COVID CAP) domain will be added and reported in a future dataset update. Assessment stage / timepoints Baseline (pre‑randomisation) Daily during index hospital admission (censored at discharge) Day 14 (modified WHO ordinal scale) Day 21 (primary outcome window) Day 28 (core secondary outcomes) Day 90 and Day 180 (mortality, longer‑term outcomes and QoL measures) Key dataset notes Data are de‑identified; dates are provided relative to randomisation (days since randomisation). Site identifier and strata/state information are included to permit stratified analyses. Missingness indicators are provided for major variables. Anticoagulation domain variables (for the non‑COVID CAP cohort) will include intervention allocation (dose/regimen), thrombotic and bleeding outcomes, and anticoagulation‑specific safety labs - these variables will be added to the dataset and documented in an updated metadata file when available. The ANZCTR trial record is linked to provide full protocol and trial context.

Notes

HeSANDA 1.0.0