Overview

Inhaled Ciclesonide for Outpatients With COVID19

Status:
Terminated
Trial end date:
2021-07-08
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Treatments:
Ciclesonide
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