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Inhaled Ciclesonide for Outpatients With COVID19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435795
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Ezer, MD, FRCPC, MPH, McGill University Health Centre/Research Institute of the McGill University Health Centre

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. We propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. We 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: Ciclesonide Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 454 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
Estimated Study Start Date : June 25, 2020
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : March 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

Arm Intervention/treatment
Active Comparator: Ciclesonide inhaled and nasal
Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled cilcesonide 600mcg BID x 14 days
Drug: Ciclesonide
Ciclesonide (600mcg BID inhaled with aerochamber) plus nasal ciclesonide (200 mcg DIE)

Placebo Comparator: Placebo
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
Drug: Ciclesonide
Ciclesonide (600mcg BID inhaled with aerochamber) plus nasal ciclesonide (200 mcg DIE)




Primary Outcome Measures :
  1. Improvement in dyspnea at day 7 [ Time Frame: day 7 ]
    Dyspnea improvement is defined as a 15%, or greater, decline in dyspnea intensity. To measure dyspnea intensity, we will use a validated patient reported outcome measure called the Promis dyspnea characteristics scale.


Secondary Outcome Measures :
  1. Hospitalization at day 14 [ Time Frame: day 14 ]
    Hospitalization for SARS-CoV-2 related illness at day 14

  2. Oxygen Use [ Time Frame: day 14 ]
    Incidence and duration of new oxygen use during the trial (defined as oxygen use not present at randomization) at day 14

  3. Mortality [ Time Frame: day 14 and 29 ]
    All cause mortality

  4. Clinical status [ Time Frame: day 7 and 14 ]
    Ordinal Scale for Evaluating subject Clinical Status at day 7 and 14

  5. Anxiety [ Time Frame: day 7 and 14 ]
    Promis Anxiety 7a scale

  6. Sleep Disturbance [ Time Frame: day 7 and 14 ]
    Promis Sleep disturbance 4a scale

  7. Exercise capacity [ Time Frame: day 7 and 14 ]
    The "Three-minute step test" will be measured in men and women to determine the impact of SARS-CoV-2 on exercise capacity



Information from the National Library of Medicine

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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. 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
  • Anticipated transfer to another hospital within 72 hours which is not a study site
  • Known or suspected pregnancy
  • 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

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


Contacts
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Contact: Nicole Ezer (514)-934-1934 ext 76192 nicole.ezer@mcgill.ca
Contact: Rola Hamed (514)-934-1934 ext 76213 rola.hamed@mail.mcgill.ca

Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
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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
Last Update Posted: June 17, 2020
Last Verified: June 2020
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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Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents