Study Sponsor: Research Institute McGill University Health Center
Why treat COVID-19 with ciclesonide?
Laboratory studies of the COVID-19 virus in cells have shown that treatment with ciclesonide can decrease viral replication.
The COVID-19 virus replicates in the nose and airways and eventually causes damage to the lung tissue.
This damage can cause difficulty breathing.
Recently a study of dexamethasone has shown improved survival among very sick patients requiring oxygen.
The individuals treated with steroids in the trial had better outcomes.
We hypothesize that treatment with inhaled and nasal ciclesonide (a type of steroid)
will reduce viral replication and decrease severity of COVID-19 illness.
We hope this will avoid deterioration among mild cases of COVID-19, avoiding the need for hospitalization and oxygen.
For more information on COVID-19 illness click here.
Determine whether 14 days of inhaled and nasal ciclesonide compared to placebo decreases the severity of shortness of breath among non-hospitalized patients with confirmed symptomatic COVID-19.
Determine whether 14 days of inhaled and nasal ciclesonide compared to placebo decreases hospitalization and need for oxygen among non-hospitalized patients with confirmed symptomatic COVID-19.
You can register online, and all follow-ups will be online or by phone with our study coordinators.
If you are eligible for the CONTAIN study, you will receive either ciclesonide (in an inhaler and nasal spray) or placebo (also in an inhaler and nasal spray). You may not choose the group to which you will be assigned; this process is done randomly like flipping a coin. One person out of 2 (50%) will receive the study drug whereas one person out of 2 (50%) will receive the placebo.
Study drug delivered to your door!
After enrolling, you will receive the study drug to your home address by courrier.
Ciclesonide is a steroid drug currently used for asthma and nasal rhinitis. It was approved by Health Canada in 2008 and is regularly prescribed by family doctors and lung specialists.
Side effects of ciclesonide are relatively uncommon and mild. The most common side effect (occurs in 1% of patients) is oral thrush (candida).
Candida is a type of fungus that we all have in our mouth, but when the mouth and the throat are in contact with corticosteroids like ciclesonide, it can sometimes grow and cause spotty white blotches on the tongue and throat.
Other symptoms can be change in the voice (1%) a change in the taste of food (0.3%) and a throat irritation (0.3%).
These side effects stop when the drug is stopped.
Click here to see how to use the nasal spray correctly. The proper use of the nasal spray helps increase its efficacy and reduce the risk of possible side effects.
Click here to see how to best take the inhaled ciclesonide. We recommend the use of an aero chamber in order to avoid oral thrush.
Compared to medications taken by the mouth or by intravenous injections, inhalers and sprays have the advantage of acting directly in the nose, the airways and the lungs and do not enter the blood stream.
Ciclesonide deposits in the nose and lung, and acts locally.
We know the COVID-19 virus starts by multiplying in the nose and progresses downwards to the lower parts of the airways and lungs. Our study aims to act on COVID-19 at the site of viral replication.
● >18 years of age
● Laboratory confirmed COVID-19 as determined by PCR within 5 days of study enrolment
● Symptoms of COVID-19 within 5 days of study enrolment such as fever, shortness of breath, or cough.
● Valid Quebec medicare card
● Signing of informed consent for study participation
● Already on inhaled corticosteroid medication
● Currently using oral or intramuscular steroids within 7 days prior to enrolment
● Severely ill at enrollment (i.e., admitted to ICU at admission)
● Allergy to ciclesonide
● Allergy to lactose (type I allergy) a non medicinal component of ciclesonide
● Suffering from untreated fungal, bacterial or tubercular infections of the respiratory tract
Nicole Ezer, Respirologist, MD, MPH
James Martin, Respirologist, MD, Dsc
Todd Lee Infectious Diseases, MD Msc
Emily Macdonald Internal Medicine, MD, Msc
Susan Bartlett, Clinical Psychologist, Senior Scientist
Andrea Benedetti, Epidemiology and Biostatistics PHD
Annie-Claude Jalbert, MD
Rola Hamed, MsC
Ankita Ghatak, MSc Candidate
Ben Smith, Respirologist, MD, Msc
What happens if I want to stop taking the medication?
You can decide to stop the study medication at any time during the study, for any reason. Please advise us on the next survey you will receive that you stopped the medication as it will help us analyze the final results. If you agree, we will continue following you and sending you questionnaires until the end of the study. You may also decide to withdraw from the project at any time, without giving any reason, by informing the study doctor or a member of the research team.
Will I be compensated?
You will not receive financial compensation for participating in this research study. The research drug, ciclesonide or placebo, plus an aerochamber, will be provided to you free of charge for the duration of this research study.
Do I stop taking the medication if I feel better?
No! You need to continue your medication for its total duration (14 days) even if you feel your symptoms are improving.
What happens if I feel worse/my symptoms get worse?
If your symptoms of COVID-19 are worsening and you are concerned about your health, you need to let us know via phone or email (see contact information). As this is a distance study with online follow up, if you need urgent or emergent care, you will need to go through routine health procedures (i.e., contact your doctor, emergency department, call 911).
NCT trial number: NCT04435795
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Commanditaire de l’étude: Institut de recherche Centre universitaire de santé mcGill