NCT04435795

Inhaled Ciclesonide for Outpatients With COVID19

Ciclesonide Clinical Trial for COVID-19 Treatment

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-09-15
• Primary completion: 2021-06-08
• Completion: 2021-07-08
• First posted: 2020-06-17
• Last updated: 2022-06-10
• Results posted: 2022-04-29

Locations

3 sites across 1 country: Canada