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0 0.25 0.5 0.75 1 1.25 1.5 1.75 2+ Hospitalization 54% Improvement Relative Risk Hospitalization/ER 81% primary Recovery 15% Recovery time 7% post-hoc primary c19budesonide.com/clemency.html Favors budesonide Favors control
22 November 2021 - Early treatment study
Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19
Clemency et al., JAMA Internal Medicine, doi:10.1001/jamainternmed.2021.6759 (Peer Reviewed)
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RCT 400 outpatients in the USA, showing significantly lower ER visits/hospital admission with ciclesonide treatment. NCT04377711.
Publication was delayed about a year after completion and the primary endpoint was changed about 4 months after the end of the trial on April 9, 2021 [1, 2]. The original primary outcome was the more important ER visits/hospital admission, which shows a statistically significant improvement OR 0.18 [0.04-0.85].
risk of hospitalization, 54.1% lower, RR 0.46, p = 0.26, treatment 3 of 197 (1.5%), control 7 of 203 (3.4%), NNT 52, odds ratio converted to relative risk.
risk of hospitalization/ER, 81.2% lower, RR 0.19, p = 0.03, treatment 2 of 197 (1.0%), control 11 of 203 (5.4%), NNT 23, odds ratio converted to relative risk.
risk of no recovery, 15.1% lower, RR 0.85, p = 0.25, treatment 58 of 197 (29.4%), control 74 of 203 (36.5%), NNT 14, odds ratio converted to relative risk, day 30.
recovery time, 7.4% lower, relative time 0.93, p = 0.55, treatment 197, control 203, Cox regression.
Effect extraction follows pre-specified rules prioritizing more serious outcomes.
Clemency et al., 11/22/2021, Double Blind Randomized Controlled Trial, USA, North America, peer-reviewed, 7 authors, study period 11 June, 2020 - 3 November, 2020.
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