Is Regulatory Capture Behind the Strange Observations Associated with the Recent COVID—19 Ciclesonide Study?

This Ciclesonide randomized controlled trial stood up to peer-review and was published in the highly regarded JAMA. However, the way they presented the results is very strange—even concerning. Why dilute the results, and lessen headline potential, like the treatment of the highly efficacious, but cheap fluvoxamine trials? Here is their conclusion: "The results of this randomized clinical trial demonstrated that ciclesonide did not achieve the primary efficacy endpoint of a reduced time to alleviation of all COVID-19–related symptoms."

Thanks to a tip from a long-standing, TrialSite community member from Orange County, California we report these findings. That's an unimpressive-sounding result. However, the details from the trial showed that their secondary endpoint was that participants who were treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons related to COVID-19 (odds ratio, 0.18; 95% CI, 0.04-0.85). No participants died during the study. The Phase 3 study was sponsored by Covis Pharma S.à.r.L.

An 82% risk reduction in emergency room visits and/or hospitalization due to COVID-19 is something that could make a massi...

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