COVID 19Phase 2/3CONTAINNCT04435795

Inhaled Ciclesonide for Outpatients With COVID19

A Phase 2/3 study testing Ciclesonide and Ciclesonide nasal in people with COVID 19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID 19
What is being tested?: Ciclesonide and Ciclesonide nasal
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 215 participants
Where: 3 sitesCanada
Study dates: 15 Sep 2020to 8 Jul 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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))

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Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract
Current hospitalization
Current use of oxygen at home or in the hospital

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

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

Other trials in Canada

About this study

Official title: 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.

Conditions: COVID 19
Being tested: Normal Saline intranasal and placebo inhaler, Ciclesonide, Ciclesonide nasal
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Normal Saline intranasal and placebo inhalerDrug
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
CiclesonideDrug
Also called Alvesco
Ciclesonide 600mcg BID inhaled with aero chamber
Ciclesonide nasalDrug
Also called Omnaris
intranasal ciclesonide 200 mcg DIE

Study groups in NCT04435795
Study group	Role	What they receive
Ciclesonide inhaled and nasal	Active comparator	Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Receives: Drug: Ciclesonide; Drug: Ciclesonide nasal
Placebo	Placebo comparator	Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Receives: Drug: Normal Saline intranasal and placebo inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: day 7

Secondary outcomes (7)

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
Measured: 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"
Measured: 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"
Measured: 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.
Measured: 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
Measured: day 7
Proportion of Participants Hospitalized for SARS-CoV-2
Hospitalization for SARS-CoV-2 related illness
Measured: day 14
Mortality
All cause mortality
Measured: day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 20208 Jul 2021

First posted17 Jun 2020
Study start15 Sep 2020
Primary completion8 Jun 2021
Study completion8 Jul 2021

Why it stopped: could not meet target enrolment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID 19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04435795
Sponsor's protocol ID: 2021-6696
Acronym: CONTAIN
Status last verified: May 2022
First submitted: 16 Jun 2020
Last updated: 10 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 34728476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ciclesonide Clinical Trial for COVID-19 Treatment
ClinicalTrials.gov ID: NCT04435795
Acronym / sponsor ID: CONTAIN / 2021-6696
Conditions: COVID 19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: could not meet target enrolment
Enrolment: 215 participants (actual)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
Study start: 15 Sep 2020 (actual)
Primary completion: 8 Jun 2021 (actual)
Study completion: 8 Jul 2021 (actual)
First posted: 17 Jun 2020 (actual)
Results: Posted 29 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Ciclesonide inhaled and nasal	Active comparator	Drug: Ciclesonide, Drug: Ciclesonide nasalIntranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days
Placebo	Placebo comparator	Drug: Normal Saline intranasal and placebo inhalerNormal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Normal Saline intranasal and placebo inhalerNormal Saline intranasal BID and Placebo 3 puff MDI inhaled BID	Drug	Placebo
CiclesonideAlso: AlvescoCiclesonide 600mcg BID inhaled with aero chamber	Drug	Ciclesonide inhaled and nasal
Ciclesonide nasalAlso: Omnarisintranasal ciclesonide 200 mcg DIE	Drug	Ciclesonide inhaled and nasal

Primary outcome

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

7 secondary outcomes

Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
Time frame: Day 14
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7
Time frame: Day 7
Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14
Time frame: Day 14
Improvement in Dyspnea: Resolution of Dyspnea at Day 7
Time frame: day 7
Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7
Time frame: day 7
Proportion of Participants Hospitalized for SARS-CoV-2
Time frame: day 14
Mortality
Time frame: day 29

Results and safety

Results posted to the registry on 29 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ciclesonide Inhaled and Nasal	108	105
Placebo	107	98

Primary outcome: Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea

Time frame: day 7. Count of participants. Unit: Participants

Measure	Ciclesonide Inhaled and Nasal n = 105	Placebo n = 98
Value	42	34

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ciclesonide Inhaled and Nasal	7 of 105 (6.7%)	23 of 105 (21.9%)	0 of 105
Placebo	5 of 98 (5.1%)	15 of 98 (15.3%)	0 of 98

Limitations and caveats (from the sponsor): We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination. In addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group. As our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34728476Ezer 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.
Trial websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea (time frame: day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04435795, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.