3 ms·
That assumes the effect in the study is real and that there is no increase in mortality or ICU admission: unfortunately stopping the trial early casts doubt on
by gregwebs 6y ago
That assumes the effect in the study is real and that there is no increase in mortality or ICU admission: unfortunately stopping the trial early casts doubt on that.
- mlyle 6y agoI'm speaking just to the specific point I replied to. That's why I couched it with "that was implied". Secondary endpoints, decisions about when to end trials, etc, are all fraught with peril. It's worth noting that neither SIMPLE nor the ACTT-1 Remdesivir studies moved from a mortality to a non-mortality endpoint. SIMPLE did have an endpoint change before any data was available, but it was a relatively minor, innocuous thing. > The primary efficacy end point was clinical status assessed on day 14 on a 7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to Covid-19); 6, hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for remdesivir administration); and 7, not hospitalized (see Table S1 in the Supplementary Appendix, available at NEJM.org).