COVIS PHARMA GROUP Announces Top-line Safety and Efficacy Data from a Phase 3 Placebo Controlled COVID-19 Study Using Inhaled Corticosteroid (ciclesonide)
Zug, Switzerland, April 15, 2021 – Covis Pharma Group (the “Company”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, announced today top-line results from a 400 patient phase 3, 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.
Alvesco (ciclesonide) Inhalation Aerosol is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. Alvesco Inhalation Aerosol is an inhaled glucocorticoid with a small particle size (1-2 µm) enabling it to reach areas of chronic inflammation in both the large and small airways. Alvesco is not indicated for the relief of acute bronchospasm. Alvesco is not indicated for children under 12 years of age in the U.S. or under the age of 6 in Canada.
Indication: ALVESCO is indicated for the prophylactic management of steroid-responsive bronchial asthma in adults, adolescents and children 6 years of age and older.
- ALVESCO (ciclesonide) is contraindicated in patients with known hypersensitivity to any of the ingredients. For a complete listing, see Dosage Forms, Composition and Packaging section of the PM.
- ALVESCO is contraindicated in patients with untreated fungal, bacterial or tuberculosis infections of the respiratory tract.
- ALVESCO is not to be used in the primary treatment of status asthmaticus or other acute episodes of asthma, or in patients with moderate to severe bronchiectasis.
United States of America
Indication: ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adults and adolescents 12 years of age and older.
Important Limitations of USE:
- ALVESCO is NOT indicated for the relief of acute bronchospasm.
- ALVESCO is NOT indicated for children under 12 years of age.
Important Safety Information for Alvesco (ciclesonide) Inhalation Aerosol
- Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required.
- Patients with a known hypersensitivity to ciclesonide or any of the ingredients of Alvesco.
Warnings & Precautions
- Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse mouth following inhalation.
- Potential worsening of existing tuberculosis: fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with above because of the potential for worsening of these infections.
- Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Alvesco.
- Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function with very high dosages or at the regular dosage in susceptible individuals. If such changes occur discontinue Alvesco slowly.
- Suppression of growth in children. Monitor growth routinely in pediatric patients receiving Alvesco.
- Development of glaucoma, increased intraocular pressure and posterior subcapsular cataracts. Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.
Covis, with global operations in Zug, Switzerland, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.
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