Infectious Disease

Alvesco no better than placebo for relief of COVID-19 symptoms

November 22, 2021

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Disclosure:
Pardon reports grants from Covis Pharma, the National Center for Advancing Translational Sciences of the NIH, and the National Heart, Lung, and Blood Institute of the NIH while conducting the study, and grants from the National Institute of Allergy and Infectious Diseases outside of the study. Please refer to the study for all relevant financial information from the other authors.

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Non-hospitalized patients with COVID-19 who received the inhaled glucocorticoid Alvesco had the same recovery time as those who received placebo, data from a phase 3 study showed.

Alvesco (Ciclesonide, Covis Pharma) is FDA approved as prophylactic therapy for patients 12 years and older with asthma, according to the agency. Systemic corticosteroids are widely used in patients with severe COVID-19, but the role of inhaled corticosteroids in patients with mild to moderate COVID-19 “is less clear,” researchers wrote in JAMA Internal Medicine.

Reference: Clemency BM, et al. JAMA Intern Med. 2021; doi: 10.1001 / jamainternmed.2021.6759.

“In vitro, ciclesonide has antiviral properties against COVID-19 and blocks virus replication of COVID-19.” Brian M. Clemency, DO, a professor in the Emergency Medicine Department at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, and colleagues wrote. “One case series described three elderly patients with hypoxia due to COVID-19 who recovered after treatment with ciclesonide. Clinical trials are needed to determine the effects of ciclesonide on COVID-19 in the clinical setting. ”

Clemency and colleagues randomly assigned 400 non-hospitalized patients with COVID-19 (mean age 43.3 years; 55.3% women; 86.3% white) to a metered dose inhaler containing 320 g of ciclesonide (n = 197) or placebo ( n = 203) administered twice daily.

According to the researchers, the median time to relief of COVID-19-related symptoms – which was the study’s primary efficacy endpoint – in the ciclesonide cohort was 19 days (95% CI, 14-21) and 19 days (95% – KI, 16-23) in the placebo cohort. In addition, there was no significant difference in the resolution of all COVID-19 symptoms by day 30 (OR = 1.28; 95% CI, 0.84-1.97).

Regarding the secondary endpoints of the study, there were significantly fewer emergency room visits and hospital admissions for COVID-19-related reasons in the ciclesonide cohort compared to the placebo cohort (OR = 0.18; 95% CI, 0.04–0 , 85). All other secondary endpoints – decrease in incidence of other hospitalizations or deaths, all-cause mortality, and COVID-19-related mortality; Increase the percentage of participants with relief from COVID-19-related symptoms and time to hospital admission or death compared to placebo on top of standard supportive care; and alleviation of all COVID-19-related symptoms on days 7, 14, and 30 after treatment – were statistically insignificant.

In addition, 11.2% of patients in the ciclesonide cohort and 14.3% of patients in the placebo cohort experienced at least one adverse event during the study. The most common side effect in both cohorts was dry mouth, followed by headache and oral candidiasis. No patients died during the study.

“Future studies of inhaled steroids are needed to evaluate their effectiveness in patients at high risk for disease progression and to reduce the incidence of long-term COVID-19 symptoms or post-acute consequences of SARS-CoV-2,” Clemency and colleagues wrote .

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