Inhaled Ciclesonide for Outpatients With COVID19

COVID 19 Clinical Trial

— CONTAIN  

Official title:

Ciclesonide Clinical Trial for COVID-19 Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04435795
• Other study ID #: 2021-6696
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 15, 2020
• Est. completion date: July 8, 2021

Study information

• Verified date: May 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 215
• Est. completion date: July 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Drug:
• Normal Saline intranasal and placebo inhaler
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
• Ciclesonide
Ciclesonide 600mcg BID inhaled with aero chamber
• Ciclesonide nasal
intranasal ciclesonide 200 mcg DIE

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec
Canada	Sunnybrook Hospital	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea	Proportion of participants with no symptoms of cough, fever or dyspnea at day 7	day 7
Secondary	Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea	Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14	Day 14
Secondary	Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7	Proportion who are reporting that they are "very much improved" or "much improved"	Day 7
Secondary	Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14	Proportion who are reporting that they are "very much improved" or "much improved"	Day 14
Secondary	Improvement in Dyspnea: Resolution of Dyspnea at 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.	day 7
Secondary	Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at 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	day 7
Secondary	Proportion of Participants Hospitalized for SARS-CoV-2	Hospitalization for SARS-CoV-2 related illness	day 14
Secondary	Mortality	All cause mortality	day 29

External Links

•   Trial website