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Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint

Covis Pharma said that a Phase 3 trial of Alvesco ciclesonide MDI for the treatment of COVID-19 in 400 patients who have not been hospitalized failed to meet its primary endpoint, which was freedom from COVID-19 symptoms for 24 continuous hours by Day 30. The difference in time to alleviation of patients’ COVID-19 symptoms was 70.6% for the ciclesonide MDI and 63.5% for placebo, which was not statistically significant.

Covis, which acquired US rights to the Alvesco inhaler from Sunovion in 2017 and acquired non-US rights to Alvesco from AstraZeneca in 2018, had announced the initiation of the trial in May 2020.

Professor Michael Blaiss of the Medical College of Georgia, commented, “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.”

Read the Covis Pharma press release.

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published on April 19, 2021

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