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0 0.5 1 1.5 2+ Hospitalization 54% Improvement Relative Risk Hospitalization/ER 81% primary Recovery 15% Recovery time 7% post-hoc primary c19early.org/u Clemency et al. NCT04377711 Budesonide RCT EARLY TREATMENT Is early treatment with budesonide beneficial for COVID-19? Double-blind RCT 400 patients in the USA (June - November 2020) Fewer hosp./ER visits with budesonide (p=0.03) Clemency et al., JAMA Internal Medicine, doi:10.1001/jamainternmed.2021.6759 Favors budesonide Favors control
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, NCT04377711 (history)
Clemency et al., Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19, JAMA Internal Medicine, doi:10.1001/jamainternmed.2021.6759, NCT04377711
Nov 2021   Source   PDF  
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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.
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.
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.
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.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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).
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This PaperBudesonideAll
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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