Status: Finalised
First registered on:
15/09/2020
Last updated on:
22/02/2023
1. Study identification
EU PAS Register NumberEUPAS37205
Official titleSociodemographic, clinical and pharmacological characteristics associated with the prognosis of patients with SARS-CoV-2 infection (Características sociodemográficas, clínicas y farmacológicas asociadas con el pronóstico en pacientes con infección por SARS-CoV-2)
Study title acronym
Study typeObservational study
Brief description of the studyStudy to assess the sociodemographic, clinical and pharmacological characteristics of patients with COVID19 in Catalonia, Spain, with data from SIDIAP database.
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 to which the investigator belongsIDIAPJGol
Department/Research groupInstitut Universitari d'Investigació en Atenció Primària Jordi Gol
Organisation/affiliationIDIAPJGol
Details of (Primary) lead investigator
Title Dr
Last name Rosa
First name Morros Pedrós
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/05/202001/06/2020
Start date of data collection01/06/202010/08/2020
Start date of data analysis21/09/202031/10/2020
Date of interim report, if expected
Date of final study report30/11/202031/12/2020
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 councils
EU funding scheme
OtherIDIAPJGol100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Maria
First name Giner-Soriano
Address line 1Gran Via de les Corts Catalanes 587
Address line 2àtic
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34934824110
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Maria
First name Giner-Soriano
Address line 1Gran Via de les Corts Catalanes 587
Address line 2àtic
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34934824110
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)J07 (combinations)
7. Medical conditions to be studied
Medical condition(s)Yes
Coronavirus disease 2019
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
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 subjects800000
Additional information
Study in all SIDIAP population (7 million people)
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Drug utilisation study
Effectiveness evaluation
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
Assess infection rate for SARS-CoV-2 and describe sociodemographic, clinical and pharmacological characteristics.
Are there primary outcomes?Yes
Infection rate for SARS-CoV-2
Are there secondary outcomes?Yes
Association between sociodemographic, clinical and pharmacological characteristics with the prognosis of COVID19 patients
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Exploration of events, logistic conditional regression, risk estimation
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Giner-Soriano M, de Dios V, Ouchi D, Vilaplana-Carnerero C, Monteagudo M, Morros R. Outcomes of COVID-19 Infection in People Previously Vaccinated Against Influenza: Population-Based Cohort Study Using Primary Health Care Electronic Records. JMIR Public Health Surveill 2022;8(11):e36712.https://doi.org/10.2196/36712
Dan Ouchi, Carles Vilaplana-Carnerero, Vanessa de Dios, Maria Giner-Soriano, Rosa Morros. Antidiabetic treatment and COVID-19 Outcomes: A population-based cohort study in primary health care in Catalonia during the first wave of the pandemic. Primary Care Diabetes 2022;16:753-759.https://doi.org/10.1016/j.pcd.2022.10.001
Maria Giner-Soriano, Ainhoa Gomez-Lumbreras, Cristina Vedia, Dan Ouchi, Rosa Morros. Risk of thrombotic events and other complications in anticoagulant users infected with SARS-CoV-2: an observational cohort study in primary health care in SIDIAP (Catalonia, Spain). BMC Primary Care 2022;23:147.https://doi.org/10.1186/s12875-022-01752-5
Carl Llor, Dan Ouchi, Maria Giner-Soriano, Ana García-Sangenís, Lars Bjerrum, Rosa Morros. Correlation between previous antibiotic exposure and COVID-19 severity. A population-based cohort study. Antibiotics 2021;10(11):1364.https://doi.org/10.3390/antibiotics10111364
Francisco Mera Cordero, Sara Bonet Monné, Jesús Almeda Ortega, Sara Contreras-Martos, Dan Ouchi, Maria Giner-Soriano, Rosa Morros Pedrós, Betlem Salvador. Montelukast and COVID-19 related complications in people with SARS-CoV-2 infection: a population-based observational study. XXXI Congreso Nacional Sociedad Española de Farmacología Clínica, virtual, 22-23 marzo 2022. Basic & Clinical Pharmacology & Toxicology 2022;abstract #36https://doi.org/10.3390/Jcm10153293
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
