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Covis Pharma Group announces top-line safety and efficacy data from a phase III placebo controlled COVID-19 study using inhaled corticosteroid (ciclesonide).
Covis Pharma Group , a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, announced top-line results from a 400 patient phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ciclesonide metered-dose inhaler in non-hospitalized patients 12 years of age and older with symptomatic COVID-19 infection.
The primary endpoint of the study was time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of = 24 hours by Day 30. A sub-group analysis showed that time to alleviation of cough was the most improved symptom in the ciclesonide arm compared to the placebo arm by 6 days in 75% of the population.
A relevant secondary efficacy endpoint reaching statistical significance (p=0.0301) was the 70% reduction observed in the ciclesonide arm versus 30% in the placebo arm of patients with subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19 by Day 30. There were only a small number (n=10) of total events observed in this study. No new safety signals were identified with ciclesonide 320mcg twice daily for 30 days in the active comparator arm versus placebo. In addition, no new adverse events were reported after 60 days post treatment with ciclesonide.
The study randomized 400 patients in a 1:1 ratio to ciclesonide versus placebo. The study demonstrated a treatment difference between ciclesonide (70.6%) and placebo (63.5%) in the percentage of patients with an improved time to alleviation of COVID-19 related symptoms, which was not statistically significant, with a p-value of 0.5502.
“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.
Condition: Coronavirus/COVID-19 Infection
Type: drug