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Inhaled Ciclesonide for Outpatients With COVID19 (CONTAIN)

Primary Purpose

COVID 19

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Normal Saline intranasal and placebo inhaler
Ciclesonide
Ciclesonide nasal
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID 19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia
  • Sunnybrook Hospital
  • McGill University Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ciclesonide inhaled and nasal

Placebo

Arm Description

Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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"
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"
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.
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
Proportion of Participants Hospitalized for SARS-CoV-2
Hospitalization for SARS-CoV-2 related illness
Mortality
All cause mortality

Full Information

First Posted
June 16, 2020
Last Updated
May 17, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04435795
Brief Title
Inhaled Ciclesonide for Outpatients With COVID19
Acronym
CONTAIN
Official Title
Ciclesonide Clinical Trial for COVID-19 Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
could not meet target enrolment
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciclesonide inhaled and nasal
Arm Type
Active Comparator
Arm Description
Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Intervention Type
Drug
Intervention Name(s)
Normal Saline intranasal and placebo inhaler
Intervention Description
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Other Intervention Name(s)
Alvesco
Intervention Description
Ciclesonide 600mcg BID inhaled with aero chamber
Intervention Type
Drug
Intervention Name(s)
Ciclesonide nasal
Other Intervention Name(s)
Omnaris
Intervention Description
intranasal ciclesonide 200 mcg DIE
Primary Outcome Measure Information:
Title
Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
Description
Proportion of participants with no symptoms of cough, fever or dyspnea at day 7
Time Frame
day 7
Secondary Outcome Measure Information:
Title
Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
Description
Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14
Time Frame
Day 14
Title
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7
Description
Proportion who are reporting that they are "very much improved" or "much improved"
Time Frame
Day 7
Title
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14
Description
Proportion who are reporting that they are "very much improved" or "much improved"
Time Frame
Day 14
Title
Improvement in Dyspnea: Resolution of Dyspnea at Day 7
Description
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.
Time Frame
day 7
Title
Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7
Description
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
Time Frame
day 7
Title
Proportion of Participants Hospitalized for SARS-CoV-2
Description
Hospitalization for SARS-CoV-2 related illness
Time Frame
day 14
Title
Mortality
Description
All cause mortality
Time Frame
day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3K 2M2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34728476
Citation
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.
Results Reference
derived

Learn more about this trial

Inhaled Ciclesonide for Outpatients With COVID19

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