Status: Ongoing
First registered on:
19/06/2020
Last updated on:
06/07/2020
1. Study identification
EU PAS Register NumberEUPAS35897
Official titleInhaled corticosteroids and COVID-19 morbidity: Nationwide cohort study
Study title acronym
Study typeObservational study
Brief description of the studyStudy of corticosteroids in COVID-19 in comparison with influenza.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameStatens Serum Institut
Centre locationArtillerivej 5, DK-2300, Copenhagen
Details of (Primary) lead investigator
Title Mr
Last name Husby
First name Anders
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?2
Statens Serum Institut, Copenhagen, Denmark
Countries in which this study is being conducted
National study
Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/07/2020
Start date of data collection06/07/2020
Start date of data analysis06/07/2020
Date of interim report, if expected
Date of final study report03/08/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councilsvarious100
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Husby
First name Anders
Address line 1Artillerivej 5
Address line 2
Address line 3
CityCopenhagen
PostcodeD-2300
CountryDenmark
Phone number (incl. country code)004532688662
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Mr
Last name Husby
First name Anders
Address line 1Artillerivej 5
Address line 2
Address line 3
CityCopenhagen
PostcodeD-2300
CountryDenmark
Phone number (incl. country code)004532688662
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)R03BA (Glucocorticoids)
7. Medical conditions to be studied
Medical condition(s)Yes
COVID-19
Influenza
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects50000
Additional information
Approximately 12,000 test positive hospitalized SARS-CoV-2 subjects.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Prospective patient-based data collection
Disease/case registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The investigate the effect of inhaled corticosteroids on SARS-CoV-2 morbidity.
Are there primary outcomes?Yes
We investigate the 30-day hazard ratio of mechanical ventilation or death among users of inhaled corticosteroids (ICS) compared with users of inhaled β2-receptor agonist and/or muscarinic receptor antagonists but not ICS (non-ICS inhaler), or no inhaled pharmaceutical use. The analysis was done for COVID-19 and influenza patients, respectively.
Are there secondary outcomes?Yes
Substudy of subtypes of inhaled corticosteroids with regards to the primary outcomes.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
30-day follow-up from positive test date.
15. Data analysis plan
Please provide a brief summary of the analysis method
Our main analysis was conducted among hospitalized test-positive individuals for influenza (in 2010-2018) and COVID-19 (in 2020), respectively. We followed participants for 30 days from the date of testing positive until either mechanical ventilation, death, or loss to follow-up from other causes. We used Cox proportional hazards regression to estimate the hazard ratios of death and mechanical ventilation comparing exposure groups. We estimated 30-day cumulative hazards according to exposure status taking competing risks into account using the Nelson-Aalen estimator. In the Cox models, we took potential confounders into account through direct propensity score adjustment. Propensity scores was estimated using logistic regression of probability of exposure on the above-mentioned covariates as main effects. We estimated separate propensity scores for each exposure group of interest.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
