Outcomes
death, infections
ADVERSE EVENTS, INFECTIONS, INFUSION REACTION
To facilitate comparisons with other studies, we used the same primary endpoint and ordinal scale as in the pivotal remdesivir trial (ACCT-1) [1, not hospitalized; 2, not hospitalized, with limitation of activities and/or requiring home oxygen; 3, hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care; 4, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to covid-19 or to other medical conditions); 5, hospitalized, requiring supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow nasal cannula; 7, hospitalized, on invasive mechanical ventilation or ECMO; and 8, death.Time to recovery was calculated as days elapsed from randomization until day of recovery.Secondary outcomes included mortality by day 29, length of hospital stay, elevated level of care (ICU or high dependency unit), days on supplemental oxygen and utilization of mechanical, non-invasive ventilation or high frequency nasal cannula at any time-point and mean number of ventilator-free days alive. Degree of improvement was evaluated on three assessment scales: mean improvement in the 8-point ordinal scale from baseline and nadir value days 1–7 until days 8 and 15, and mean improvement in SOFA and NEWS2 scores from baseline until days 5, 10 and 15. We compared fractions of patients who had: achieved ordinal scale 1–4 by day 15 and who were discharged to institution other than normal domicile. The safety population was defined according to initiation of either study drug or usual care only. Safety outcomes included incidence of: serious adverse events; severe or life-threatening infections; infusion reactions.The cumulative dose of steroids was calculated for each patient. Dosages of methylprednisolone, hydrocortisone, prednisone and dexamethasone were calculated separately and converted to betamethasone equivalents. Use of remdesivir was registered.