The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19 patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used and is readily available. It has a low rate of side effects and few interactions with other drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect. Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in individuals who are not admitted to hospital at time of diagnosis of COVID-19.
Drug: Normal Saline intranasal and placebo inhaler
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Drug: Ciclesonide
Ciclesonide 600mcg BID inhaled with aero chamber
Other Name: Alvesco
Drug: Ciclesonide nasal
intranasal ciclesonide 200 mcg DIE
Other Name: Omnaris
Inclusion Criteria:
Symptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with
fever, cough, or shortness of breath. Provision of Informed Consent
At day 0, patients should be at home
Exclusion Criteria:
- Already on inhaled corticosteroid medication
- Currently using systemic steroids (oral or intravenous or intramuscular such as
Prednisone) or use of steroids 7 days prior to enrolment
- Severely ill patients at enrollment (i.e., admitted to ICU at admission)
- Unable to self-administer the inhaler
- Known or suspected pregnancy and breastfeeding
- Known allergy to study medication or its components (non-medicinal ingredients;
including lactose allergy (type I))
- Patients with untreated fungal, bacterial, or tubercular infections of the respiratory
tract
- Current hospitalization
- Current use of oxygen at home or in the hospital
University of British Columbia
Vancouver, British Columbia, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada