A phase 3 study evaluating the efficacy and safety of ciclesonide inhalation aerosol (Alvesco) in non-hospitalized patients aged ≥12 years with symptomatic coronavirus disease 2019 (COVID-19) has been initiated by Covis Pharma.
The multicenter, double-blind, placebo-controlled study will enroll 400 patients at multiple clinical trial sites in the US. Patients will be randomized to receive either ciclesonide 320mcg inhaled twice daily or placebo, in addition to standard supportive care. The primary efficacy end point is the proportion of patients with a hospital admission or death by day 30.
“Having received approval from the FDA for our study design and protocol, we are pleased to initiate this phase 3 study,” said Michael Porter, CEO of Covis. “Should Alvesco show positive results in the study’s primary end point for reduction of patients with a hospital admission or mortality by day 30, we intend to file for approval of our drug in the US for the treatment of COVID-19.”
Initial results from the trial are expected to be released in late-August/early-September 2020.
Alvesco, an inhaled corticosteroid, is currently approved by the Food and Drug Administration (FDA) for the maintenance treatment of asthma as prophylactic therapy in patients aged ≥12 years. Preclinical data suggest that ciclesonide could potentially treat COVID-19 as it has been shown to suppress replication of human coronaviruses in cell cultures. Additionally, a recently published case series showed that treatment with ciclesonide led to favorable outcomes in 3 patients with confirmed COVID-19.
For more information covispharma.com.