Inhaled Ciclesonide for Outpatients With COVID19
- Conditions
- COVID 19
- Interventions
- Registration Number
- NCT04435795
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 215
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo Normal Saline intranasal and placebo inhaler Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Ciclesonide inhaled and nasal Ciclesonide nasal Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide inhaled and nasal Ciclesonide Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days
- Primary Outcome Measures
Name Time Method Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea day 7 Proportion of participants with no symptoms of cough, fever or dyspnea at day 7
- Secondary Outcome Measures
Name Time Method Improvement in Dyspnea: Resolution of Dyspnea at Day 7 day 7 Dyspnea was defined as reporting "shortness of breath" or "chest congestion" or "chest tightness". In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.
Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7 day 7 Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms
Mortality day 29 All cause mortality
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14 Day 14 Proportion who are reporting that they are "very much improved" or "much improved"
Proportion of Participants Hospitalized for SARS-CoV-2 day 14 Hospitalization for SARS-CoV-2 related illness
Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea Day 14 Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7 Day 7 Proportion who are reporting that they are "very much improved" or "much improved"
Trial Locations
- Locations (3)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada