In patients with mild to moderate COVID-19, ciclesonide inhaler treatment eradicates SARS-CoV-2 earlier and prevents progression to COVID-19. These were the major findings of a prospective, multicenter, randomized, open-label, phase 2 trial (ClinicalTrials.gov Identifier: NCT04330586), recently published in the Journal of Clinical Medicine.
Currently, there are no effective antiviral agents available for the treatment of COVID-19 in the outpatient setting. Ciclesonide, an inhaled steroid agent used to treat asthma, is presumed to exert antiviral effects by acting on the nonstructural proteins of SARS-CoV-2. Clinical symptoms and oxygen saturation have been shown to improve when ciclesonide was administered to patients with COVID-19 pneumonia in a case series reported from Japan. Therefore, researchers in South Korea aimed to evaluate the efficacy and adverse events of 14-day ciclesonide treatment compared with standard care in patients with mild to moderate COVID-19.
Patients were enrolled within 3 days of COVID-19 diagnosis or within 7 days from symptom onset and were randomly assigned to receive either ciclesonide (320 µg inhalation twice per day for 14 days) or standard care, with 35 and 26 patients in the ciclesonide and standard care groups, respectively.
The researchers found that the SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group (P=.021), and a multivariate analysis demonstrated that SARS-CoV-2 negative conversion within 14 days was 12 times more likely in the ciclesonide group. In addition, the clinical failure rate (high-flow nasal oxygen therapy or mechanical ventilation) was significantly lower in the ciclesonide group (P=.034).
“In conclusion, ciclesonide inhalation shortened SARS-CoV-2 viral shedding duration, and it may inhibit the progression to acute respiratory failure in patients with mild-to-moderate COVID-19,” stated the authors. They added, “Ciclesonide inhalation could be a useful therapeutic option for mild-to-moderate COVID-19 in an outpatient setting.”
Song JY, Yoon JG, Seo YB, et al. Ciclesonide inhaler treatment for mild-to-moderate COVID-19: A randomized, open-label, phase 2 trial. J Clin Med. Published online August 12, 2021. doi:10.3390/jcm10163545