Ciclesonide-COVID
Trial question
What is the effect of inhaled ciclesonide in nonhospitalized patients with symptomatic COVID-19 infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 400
400 patients (221 female, 179 male).
Inclusion criteria: nonhospitalized patients with symptomatic COVID-19 infection.
Key exclusion criteria: life-threatening co-morbidity; cystic fibrosis; hypersensitivity to ciclesonide; use of inhaled or intranasal corticosteroid; receipt of oral corticosteroids; receipt of hydroxychloroquine or chloroquine.
Interventions
N=197 ciclesonide metered dose inhaler (160 mcg per actuation, 2 actuations BID for 30 days).
N=203 placebo metered dose inhaler (matching placebo inhaler, 2 actuations BID for 30 days).
Primary outcome
Time to alleviation of all COVID-19 related symptoms by day 30
19 days
19 days
19.0 days
14.3 days
9.5 days
4.8 days
0.0 days
Ciclesonide metered dose
inhaler
Placebo metered dose
inhaler
No significant
difference ↔
No significant difference in time to alleviation of all COVID-19 related symptoms by day 30 (19 days vs. 19 days; HR 1.08, 95% CI 0.84 to 1.38).
Secondary outcomes
Significant decrease in the rate of COVID-19 related emergency department visits or hospital admissions by day 30 (1% vs. 5.4%; OR 0.18, 95% CI 0.04 to 0.85).
No significant difference in the rate of hospital admission or death by day 30 (1.5% vs. 3.4%; OR 0.45, 95% CI 0.11 to 1.84).
No significant difference in COVID-19 symptoms reduction by day 30 (70.6% vs. 63.5%; OR 1.28, 95% CI 0.84 to 1.97).
Safety outcomes
No significant difference in adverse events.
Conclusion
In nonhospitalized patients with symptomatic COVID-19 infection, ciclesonide metered dose inhaler was not superior to placebo metered dose inhaler with respect to time to alleviation of all COVID-19 related symptoms by day 30.
Reference
Brian M Clemency, Renoj Varughese, Yaneicy Gonzalez-Rojas et al. Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA Intern Med. 2022 Jan 1;182(1):42-49.
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