Thanks. That is interesting. Expert opinion is needed to evaluate the results of that study. Are there any studies which report a different result?
However, even if the theorised cytokine storm is not the usual cause of death and severe disability in Covid-ARDS patients on ventilators that still does not invalidate the observation that Covid-ARDS kills and Rem-L saves lives (if it does) in these patients. Something is doing it and if Rem-L fixes it, so what?
The FDA might grizzle about being asked to approve a treatment for which the MOA is unclear but they sure would be on the nose if they refused to approve something (Rem-L) that was proven to dramatically save lives in a RCT that they had sanctioned. The US is heading for 400,000 Covid-ARDS fatalities early next year, cytokine storm or not. There is a good chance that Rem-L can make a real difference.
Elevated cytokines is not a required inclusion criterion for the trial. Changes in inflammatory marker levels are studied for the secondary outcome measures but there is no requirement for any particular result to qualify.
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