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Trial record 1 of 1 for:    NCT04435795
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Inhaled Ciclesonide for Outpatients With COVID19 (CONTAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435795
Recruitment Status : Terminated (could not meet target enrolment)
First Posted : June 17, 2020
Results First Posted : April 29, 2022
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Nicole Ezer, MD, FRCPC, MPH, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID 19 Drug: Normal Saline intranasal and placebo inhaler Drug: Ciclesonide Drug: Ciclesonide nasal Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ciclesonide Clinical Trial for COVID-19 Treatment
Actual Study Start Date : September 15, 2020
Actual Primary Completion Date : June 8, 2021
Actual Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

Arms and Interventions
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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 Name: Alvesco

Drug: Ciclesonide nasal
intranasal ciclesonide 200 mcg DIE
Other Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea [ Time Frame: day 7 ]
    Proportion of participants with no symptoms of cough, fever or dyspnea at day 7


Secondary Outcome Measures :
  1. Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea [ Time Frame: Day 14 ]
    Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14

  2. Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7 [ Time Frame: Day 7 ]
    Proportion who are reporting that they are "very much improved" or "much improved"

  3. Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14 [ Time Frame: Day 14 ]
    Proportion who are reporting that they are "very much improved" or "much improved"

  4. Improvement in Dyspnea: Resolution of Dyspnea at Day 7 [ Time Frame: 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.

  5. Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7 [ Time Frame: 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

  6. Proportion of Participants Hospitalized for SARS-CoV-2 [ Time Frame: day 14 ]
    Hospitalization for SARS-CoV-2 related illness

  7. Mortality [ Time Frame: day 29 ]
    All cause mortality


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435795


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3K 2M2
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
  Study Documents (Full-Text)

Documents provided by Nicole Ezer, MD, FRCPC, MPH, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Study Protocol and Statistical Analysis Plan  [PDF] August 23, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nicole Ezer, MD, FRCPC, MPH, Assistant Professor of Medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04435795    
Other Study ID Numbers: 2021-6696
First Posted: June 17, 2020    Key Record Dates
Results First Posted: April 29, 2022
Last Update Posted: June 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents