Inhaled Ciclesonide for Outpatients With COVID19
NCT04435795 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 215
Last updated 2022-06-10
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.
Conditions
- COVID 19
Interventions
- 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
- DRUG
-
Ciclesonide nasal
intranasal ciclesonide 200 mcg DIE
Sponsors & Collaborators
-
McGill University Health Centre/Research Institute of the McGill University Health Centre
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-15
- Primary Completion
- 2021-06-08
- Completion
- 2021-07-08
Countries
- Canada
Study Locations
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