CONTAIN: Inhaled Ciclesonide for Outpatients With COVID19
Study Details
Study Description
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 |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
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 Names:
Drug: Ciclesonide nasal
intranasal ciclesonide 200 mcg DIE
Other Names:
|
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
Primary Outcome Measures
- Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea [day 7]
Proportion of participants with no symptoms of cough, fever or dyspnea at day 7
Secondary Outcome Measures
- Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea [Day 14]
Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14
- Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7 [Day 7]
Proportion who are reporting that they are "very much improved" or "much improved"
- Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14 [Day 14]
Proportion who are reporting that they are "very much improved" or "much improved"
- Improvement in Dyspnea: Resolution of Dyspnea at Day 7 [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.
- Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7 [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
- Proportion of Participants Hospitalized for SARS-CoV-2 [day 14]
Hospitalization for SARS-CoV-2 related illness
- Mortality [day 29]
All cause mortality
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of British Columbia | Vancouver | British Columbia | Canada | |
2 | Sunnybrook Hospital | Toronto | Ontario | Canada | M4N 3M5 |
3 | McGill University Health Center | Montreal | Quebec | Canada | H3K 2M2 |
Sponsors and Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 2021-6696
Study Results
Participant Flow
Recruitment Details | 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. |
---|---|
Pre-assignment Detail | Overall, 215 participants were randomised, and the modified intention-to-treat population included 203 adults with respiratory symptoms or fever. |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 108 | 107 |
COMPLETED | 105 | 98 |
NOT COMPLETED | 3 | 9 |
Baseline Characteristics
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 | Total of all reporting groups |
Overall Participants | 105 | 98 | 203 |
Age (years) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [years] |
35
|
35
|
35
|
Sex: Female, Male (Count of Participants) | |||
Female |
54
51.4%
|
55
56.1%
|
109
53.7%
|
Male |
51
48.6%
|
43
43.9%
|
94
46.3%
|
Race/Ethnicity, Customized (Count of Participants) | |||
African canadian |
3
2.9%
|
2
2%
|
5
2.5%
|
Asian |
18
17.1%
|
16
16.3%
|
34
16.7%
|
White |
63
60%
|
53
54.1%
|
116
57.1%
|
Hispanic or Latino |
6
5.7%
|
7
7.1%
|
13
6.4%
|
Middle Eastern |
6
5.7%
|
12
12.2%
|
18
8.9%
|
South Asian |
6
5.7%
|
6
6.1%
|
12
5.9%
|
Other |
3
2.9%
|
2
2%
|
5
2.5%
|
Region of Enrollment (Count of Participants) | |||
British Columbia |
51
48.6%
|
51
52%
|
102
50.2%
|
Ontario |
19
18.1%
|
13
13.3%
|
32
15.8%
|
Quebec |
35
33.3%
|
34
34.7%
|
69
34%
|
Outcome Measures
Title | Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea |
---|---|
Description | Proportion of participants with no symptoms of cough, fever or dyspnea at day 7 |
Time Frame | day 7 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 105 | 98 |
Count of Participants [Participants] |
42
40%
|
34
34.7%
|
Title | Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea |
---|---|
Description | Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14 |
Time Frame | Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 105 | 98 |
Count of Participants [Participants] |
95
90.5%
|
91
92.9%
|
Title | Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7 |
---|---|
Description | Proportion who are reporting that they are "very much improved" or "much improved" |
Time Frame | Day 7 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 105 | 98 |
Count of Participants [Participants] |
77
73.3%
|
74
75.5%
|
Title | Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14 |
---|---|
Description | Proportion who are reporting that they are "very much improved" or "much improved" |
Time Frame | Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 105 | 98 |
Count of Participants [Participants] |
95
90.5%
|
91
92.9%
|
Title | Improvement in Dyspnea: Resolution of Dyspnea at Day 7 |
---|---|
Description | 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. |
Time Frame | day 7 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 53 | 49 |
Count of Participants [Participants] |
38
36.2%
|
27
27.6%
|
Title | Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7 |
---|---|
Description | 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 |
Time Frame | day 7 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 89 | 86 |
Count of Participants [Participants] |
57
54.3%
|
54
55.1%
|
Title | Proportion of Participants Hospitalized for SARS-CoV-2 |
---|---|
Description | Hospitalization for SARS-CoV-2 related illness |
Time Frame | day 14 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 105 | 98 |
Count of Participants [Participants] |
6
5.7%
|
3
3.1%
|
Title | Mortality |
---|---|
Description | All cause mortality |
Time Frame | day 29 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 105 | 98 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Adverse Events
Time Frame | 29 Days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Ciclesonide Inhaled and Nasal | Placebo | ||
Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
Ciclesonide Inhaled and Nasal | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/105 (0%) | 0/98 (0%) | ||
Serious Adverse Events |
||||
Ciclesonide Inhaled and Nasal | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/105 (6.7%) | 5/98 (5.1%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Hospithalization | 6/105 (5.7%) | 3/98 (3.1%) | ||
Visit to the emergency department | 1/105 (1%) | 3/98 (3.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
Ciclesonide Inhaled and Nasal | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 23/105 (21.9%) | 15/98 (15.3%) | ||
General disorders | ||||
Severe headache | 13/105 (12.4%) | 5/98 (5.1%) | ||
Voice change | 2/105 (1.9%) | 2/98 (2%) | ||
throat irritaiton | 7/105 (6.7%) | 5/98 (5.1%) | ||
Dry mouth | 2/105 (1.9%) | 3/98 (3.1%) | ||
Dry nose, irritated nose or nosebleed | 4/105 (3.8%) | 1/98 (1%) | ||
Dizziness | 1/105 (1%) | 0/98 (0%) | ||
Nausea | 11/105 (10.5%) | 2/98 (2%) | ||
Wheeze | 0/105 (0%) | 1/98 (1%) | ||
Other | 6/105 (5.7%) | 3/98 (3.1%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Thrush | 2/105 (1.9%) | 0/98 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr Nicole EZER |
---|---|
Organization | Research Institute of the McGill University Health Center |
Phone | 514-934-1934 ext 76192 |
nicole.ezer@mcgill.ca |
- 2021-6696