Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19
RCT 400 outpatients in the USA, showing significantly lower ER visits/hospital admission with ciclesonide treatment.
NCT04377711 (history).
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
[clinicaltrials.gov, trialsitenews.com]. 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.
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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, primary outcome.
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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, inverted to make RR<1 favor treatment, odds ratio converted to relative risk, day 30.
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recovery time, 7.4% lower, relative time 0.93, p = 0.55, treatment 197, control 203, inverted to make RR<1 favor treatment, Cox regression, post-hoc primary outcome.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Clemency et al., 22 Nov 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 7 authors, study period 11 June, 2020 - 3 November, 2020, trial
NCT04377711 (history).
Abstract: Research
JAMA Internal Medicine | Original Investigation
Efficacy of Inhaled Ciclesonide for Outpatient Treatment
of Adolescents and Adults With Symptomatic COVID-19
A Randomized Clinical Trial
Brian M. Clemency, DO; Renoj Varughese, MD; Yaneicy Gonzalez-Rojas, MD; Caryn G. Morse, MD, MPH;
Wanda Phipatanakul, MD, MS; David J. Koster, MS; Michael S. Blaiss, MD
Visual Abstract
IMPORTANCE Systemic corticosteroids are commonly used in treating severe COVID-19.
However, the role of inhaled corticosteroids in the treatment of patients with mild to
moderate disease is less clear.
Supplemental content
OBJECTIVE To determine the efficacy of the inhaled steroid ciclesonide in reducing the time to
alleviation of all COVID-19–related symptoms among nonhospitalized participants with
symptomatic COVID-19 infection.
DESIGN, SETTING, AND PARTICIPANTS This phase 3, multicenter, double-blind, randomized
clinical trial was conducted at 10 centers throughout the US and assessed the safety and
efficacy of a ciclesonide metered-dose inhaler (MDI) for treating nonhospitalized participants
with symptomatic COVID-19 infection who were screened from June 11, 2020, to November
3, 2020.
INTERVENTIONS Participants were randomly assigned to receive ciclesonide MDI, 160 μg per
actuation, for a total of 2 actuations twice a day (total daily dose, 640 μg) or placebo for
30 days.
MAIN OUTCOMES AND MEASURES The primary end point was time to alleviation of all
COVID-19–related symptoms (cough, dyspnea, chills, feeling feverish, repeated shaking with
chills, muscle pain, headache, sore throat, and new loss of taste or smell) by day 30.
Secondary end points included subsequent emergency department visits or hospital
admissions for reasons attributable to COVID-19.
RESULTS A total of 413 participants were screened and 400 (96.9%) were enrolled and
randomized (197 [49.3%] in the ciclesonide arm and 203 [50.7%] in the placebo arm; mean
[SD] age, 43.3 [16.9] years; 221 [55.3%] female; 2 [0.5%] Asian, 47 [11.8%] Black or African
American, 3 [0.8%] Native Hawaiian or other Pacific Islander, 345 [86.3%] White, and 1
multiracial individuals [0.3%]; 172 Hispanic or Latino individuals [43.0%]). The median time
to alleviation of all COVID-19–related symptoms was 19.0 days (95% CI, 14.0-21.0) in the
ciclesonide arm and 19.0 days (95% CI, 16.0-23.0) in the placebo arm. There was no
difference in resolution of all symptoms by day 30 (odds ratio, 1.28; 95% CI, 0.84-1.97).
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.
CONCLUSIONS AND RELEVANCE The results of this randomized clinical trial demonstrated that
ciclesonide did not achieve the primary efficacy end point of reduced time to alleviation of all
COVID-19–related symptoms.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04377711
JAMA Intern Med. doi:10.1001/jamainternmed.2021.6759
Published online November 22, 2021.
Author Affiliations: Jacobs School of
Medicine and Biomedical Sciences,
University at Buffalo, Buffalo, New
York (Clemency, Varughese); Verus
Clinical Research Corporation, Coral
Gables, Florida (Gonzalez-Rojas);
Wake Forest School of Medicine,
Winston-Salem, North Carolina
(Morse); Boston Children's Hospital,
Harvard Medical School, Boston,
Massachusetts (Phipatanakul); Instat
Clinical Research, Chatham, New
Jersey (Koster);..
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