Ciclesonide pressurised metered-dose inhaler (pMDI).
Supportive care plus ciclesonide (Alversco) 320 mcg twice daily for 30 days via pMDI.
Placebo
Supportive care plus placebo mztching Alvesco, twice daily for 30 days via pMDI.
Standard supportive care was provided at the discretion of the study nurse or physician and included recommendations for symptomatic medications and directions to seek emergency care when necessary.
COVID 19 outpatients
Double-blind.
Multicenter; 10 centers throughout the US (public and private, academic and non-academic sites).
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 more than 24 hours (ie, later than 3 AM/PM assessments) by day 30.
Changes in primary outcome during the trial: A primary outcome based on symptom resolution was chosen rather than one based on emergency department visits or hospital admission after preliminary data demonstrated substantially lower than expected rates of emergency department visits or hospitalizations among study participants.
Ezer N (CONTAIN), 2021 NCT04435795
ciclesonide (n=108) vs. placebo (n=107)
randomized controlled trial
Ciclesonide
Inhaled ciclesonide (600 μg twice daily) along with the usual dose of intranasal ciclesonide (200 μg daily) for 14 days.
Placebo
Saline placebo metered dose inhaler and intranasal saline of a similar appearance to ciclesonide at the same dosing schedule.
COVID 19 outpatients
Adults aged 18 years and older who had polymerase chain reaction confirmed COVID-19 at enrolment with at least one of the symptoms of fever, cough (wet or dry), or shortness of breath (including dyspnoea, chest congestion, or chest tightness as synonyms). People were excluded if they were admitted to hospital, had only non-respiratory symptoms (eg, nasal congestion, myalgias, or gastrointestinal symptoms), had already been prescribed an inhaled steroid.
Double-blind.
Three Canadian provinces (Quebec, Ontario, and British Columbia).
Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021. Participants self-reported outcome data for the 14 days after enrolment, including improvement in covid-19 related respiratory symptoms, other covid-19 symptoms, adherence to the trial intervention, side effects, and hospital admissions.
