I don't think it even needs SOC to have improved markedly - the reality is that ventilator support is no longer an early option in the treatment of patients, so instead of patients being ventilated a few days after admission to ICU, they are now being ventilated as an absolute last resort. The patients are in radically different circumstances and may no longer be salvagable. SOC moved tremendously across this period and so the trial conditions are no longer valid.
One of the prime inclusion criteria was: "Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria) With an exclusion criteria of being on a ventilator for more than 3 days.
Instead of "ventilator dependent" being one of the primary preconditions for inclusion, it should have just been left with the various CT lung opacities and oxygenation impairment. Exclusion was being on the ventilator for more than 3 days - so clearly timing was important to disease progression. Unfortunately the trial used commencement of ventilation as the start of the "clock" and SOC moved that start significantly.
Claims that the Rem-L should have been just as effective regardless of the changes to SOC are in this case equivalent to saying that the success rate of "heart massage' (pulmonary resuscitation) should be just as effective if begun 10 minutes after a person collapses of a massive heart attack versus beginning after just 2 minutes.
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