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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04435795 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 24, 2021, 2 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 24, 2021, 2 a.m. Source : ClinicalTrials.gov |
nicole.ezer@mcgill.ca |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-06-17 |
|
Recruitment status
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Factorial |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : June 24, 2021, 2 a.m. Source : ClinicalTrials.gov |
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
Last imported at : June 24, 2021, 2 a.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Canada |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : June 24, 2021, 2 a.m. Source : ClinicalTrials.gov |
215 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Proportion of participants with no symptoms of cough, fever or dyspnea |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : June 24, 2021, 2 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 282, "treatment_name": "Ciclesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |