Clinical trial NCT04435795: Inhaled Ciclesonide for Outpatients With COVID19
Official title: Ciclesonide Clinical Trial for COVID-19 Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID 19
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
timeFrame: day 7
Secondary outcomes:
measure: Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
timeFrame: Day 14
measure: Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7
timeFrame: Day 7
measure: Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14
timeFrame: Day 14
measure: Improvement in Dyspnea: Resolution of Dyspnea at Day 7
timeFrame: day 7
measure: Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7
timeFrame: day 7
measure: Proportion of Participants Hospitalized for SARS-CoV-2
timeFrame: day 14
measure: Mortality
timeFrame: day 29
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
citation: Ezer N, Belga S, Daneman N, Chan A, Smith BM, Daniels SA, Moran K, Besson C, Smyth LY, Bartlett SJ, Benedetti A, Martin JG, Lee TC, McDonald EG. Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial. BMJ. 2021 Nov 2;375:e068060. doi: 10.1136/bmj-2021-068060.