Inhaled Ciclesonide for Outpatients With COVID19 (CONTAIN)

Ciclesonide Clinical Trial for COVID-19 Treatment

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.

Study Overview

• Status: Terminated
• Conditions: COVID 19
• Intervention / Treatment: Drug: Ciclesonide; Drug: Ciclesonide nasal; Drug: Normal Saline intranasal and placebo inhaler

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3K 2M2
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ciclesonide inhaled and nasal; Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days	Drug: Ciclesonide; Ciclesonide 600mcg BID inhaled with aero chamber; Other Names: Alvesco; Drug: Ciclesonide nasal; intranasal ciclesonide 200 mcg DIE; Other Names: Omnaris
Placebo Comparator: Placebo; Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID	Drug: Normal Saline intranasal and placebo inhaler; Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Proportion of Participants Hospitalized for SARS-CoV-2	Hospitalization for SARS-CoV-2 related illness	day 14
Mortality	All cause mortality	day 29

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• Ezer N, Belga S, Daneman N, Chan A, Smith BM, Daniels SA, Moran K, Besson C, Smyth LY, Bartlett SJ, Benedetti A, Martin JG, Lee TC, McDonald EG. Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial. BMJ. 2021 Nov 2;375:e068060. doi: 10.1136/bmj-2021-068060.

Helpful Links

• Trial website

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: 2021-6696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No