Topline results were announced from a phase 3 study evaluating the efficacy and safety of ciclesonide metered-dose inhaler (Alvesco; Covis Pharmaceuticals) in non-hospitalized patients 12 years of age and older with symptomatic COVID-19 infection.
The multicenter, randomized, double-blind, placebo-controlled study (ClinicalTrials.gov: NCT04377711) included 400 patients with symptomatic COVID-19 infection. Patients were randomly assigned 1:1 to receive either ciclesonide 320mcg inhaled twice daily or placebo, in addition to standard supportive care.
The primary endpoint was the time to alleviation of COVID-19-related symptoms, defined as being symptom-free for a continuous period of greater than or equal to 24 hours by day 30. Results showed that the treatment difference between ciclesonide and placebo was not found to be statistically significant (P =.5502).
In a subgroup analysis, treatment with ciclesonide was associated with an improvement in the time to alleviation of cough by day 6 in 75% of the population. Additionally, a 70% reduction in subsequent emergency department visits or hospital admissions attributable to COVID-19 was observed in the ciclesonide arm compared with a 30% reduction in the placebo arm (P =.0301); a total of 10 events occurred during the study.
“We are disappointed the results were not more positive, although there was a trend toward earlier cough cessation in the ciclesonide group. Further studies may want to look at whether this treatment may prevent or lessen post-acute COVID-19 syndrome,” said Michael Blaiss, MD, clinical professor at the Medical College of Georgia at Augusta University in Augusta, Georgia, a member of the steering committee for the trial.
Alvesco, an inhaled corticosteroid, is currently approved by the Food and Drug Administration for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Covis Pharma Group announces top-line safety and efficacy data from a phase 3 placebo-controlled COVID-19 study using inhaled corticosteroid (ciclesonide). [press release]. Zug, Switzerland: Covis Pharma Group; April 15, 2021.