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could not meet target enrolment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciclesonide inhaled and nasal | Active Comparator | Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days |
|
| Placebo | Placebo Comparator | Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline intranasal and placebo inhaler | Drug | Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 14 |
| Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | Canada | |||
| Sunnybrook Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34728476 | Derived | 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. |
| Label | URL |
|---|---|
| Trial website | View source |
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Overall, 215 participants were randomised, and the modified intention-to-treat population included 203 adults with respiratory symptoms or fever.
Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciclesonide Inhaled and Nasal | Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE |
| FG001 | Placebo | Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciclesonide Inhaled and Nasal | Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | day 7 |
|
29 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciclesonide Inhaled and Nasal | Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospithalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | SAE related to COVID-19, not to the study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrush | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nicole EZER | Research Institute of the McGill University Health Center | 514-934-1934 | 76192 | nicole.ezer@mcgill.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Apr 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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| Ciclesonide | Drug | Ciclesonide 600mcg BID inhaled with aero chamber |
|
|
| Ciclesonide nasal | Drug | intranasal ciclesonide 200 mcg DIE |
|
|
Proportion who are reporting that they are "very much improved" or "much improved" |
| 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" | 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. | 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 | day 7 |
| Proportion of Participants Hospitalized for SARS-CoV-2 | Hospitalization for SARS-CoV-2 related illness | day 14 |
| Mortality | All cause mortality | day 29 |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| McGill University Health Center | Montreal | Quebec | H3K 2M2 | Canada |
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| Secondary | 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" | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| Secondary | 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" | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | day 7 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | day 7 |
|
|
|
| Secondary | Proportion of Participants Hospitalized for SARS-CoV-2 | Hospitalization for SARS-CoV-2 related illness | Posted | Count of Participants | Participants | day 14 |
|
|
|
| Secondary | Mortality | All cause mortality | Posted | Count of Participants | Participants | day 29 |
|
|
|
| 0 |
| 105 |
| 7 |
| 105 |
| 23 |
| 105 |
| EG001 | Placebo | Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID | 0 | 98 | 5 | 98 | 15 | 98 |
|
| Visit to the emergency department | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Related to COVID-19, not to the study drug |
|
| Severe headache | General disorders | Systematic Assessment |
|
| Voice change | General disorders | Systematic Assessment |
|
| throat irritaiton | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Dry nose, irritated nose or nosebleed | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Wheeze | General disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |