TABLE 2.
Primary and secondary outcomes for the STARS trial
| Outcome | Timing |
|---|---|
| Primary outcome: PaO2/FiO2 improvement from pre‐to‐post intervention | 48 h after randomization. |
| Secondary outcomes | |
| Achievement of PaO2/FiO2 ≥200 or 50% increase in PaO2/FiO2 (whichever is lower) | 48 h after randomization |
| National Early Warning Score (NEWS) a |
48 h after randomization 14 d |
| NIAID ordinal scale b | |
| Reduction of FiO2 <80% (if started on higher concentration) | |
| Return to supine or lateral position (if started in prone position) | |
| Reduction of positive end expiratory pressure | |
| Reduction of inhaled prostonoids (if started before t‐PA therapy) | |
| Reduction of inhaled nitric oxide (if started before t‐PA therapy) | |
| Reduction of paralytic (if on before t‐PA therapy) | |
| Reciever operating characteristic curve of coagulation variables associated with achievement a PaO2/FiO2 >50% | |
| Reciever operating characteristic curve of coagulation variables associated with bleeding complications | |
| 48 h in‐hospital mortality | |
| 14 d in‐hospital mortality | 14 d |
| 28 d in‐hospital mortality | 28 d |
| ICU‐free days (up to 28 d) | 28 d |
| In‐hospital coagulation‐related event‐free (arterial and venous) days (up to 28 d) | 28 d |
| Ventilator‐free days (up to 28 d) | 28 d |
| Successful extubation (no reintubation <3 d after initial extubation) | 28 d |
| Survival to discharge | Discharge |
National Early Warning Score (NEWS2): based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness); bNIAID ordinal scale: The ordinal scale is an assessment of the clinical status as follows: (i) death; (ii) hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; (iii) hospitalized, on noninvasive ventilation or high‐flow oxygen devices; (iv) hospitalized, requiring supplemental oxygen; (v) hospitalized, not requiring supplemental oxygen–requiring ongoing medical care (COVID‐19 related or otherwise); (vi) hospitalized, not requiring supplemental oxygen—no longer requires ongoing medical care; (vii) not hospitalized, limitation on activities and/or requiring home oxygen; (viii) not hospitalized, no limitations on activities (we will combine 7 and 8 as discharge from hospital to home, as the trial is limited to in‐hospital morbidity/mortality).