Status: Planned
First registered on:
29/03/2020
Last updated on:
29/03/2020
1. Study identification
EU PAS Register NumberEUPAS34343
Official titleSpanish Registry of treatment efficacy against SARS-CoV-2 COVID-19
Study title acronymRER-FAR-COVID-19
Study typeObservational study
Brief description of the studyEvaluated the effectiveness of pharmacotherapy used in the treatment of cases of SARS-CoV2 coronavirus infection, whom have required hospital admission in Spain during the pandemic declared in March 2020.
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 nameSpanish Society of Hospital Pharmacy
Centre locationSpain
Details of (Primary) lead investigator
Title Dr
Last name Sierra Sánchez
First name Jesus F
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?14
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 signed30/03/2020
Start date of data collection30/03/2020
Start date of data analysis03/04/2020
Date of interim report, if expected10/04/2020
Date of final study report29/05/2020
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
OtherSpanish Society of Hospital Pharmacy100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Sierra Sánchez
First name Jesus F
Address line 1Ronda de Circulación s/n
Address line 2
Address line 3
CityJerez de la Frontera
Postcode
CountrySpain
Phone number (incl. country code)34617445704
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Sierra Sánchez
First name Jesus F
Address line 1Ronda de Circulación s/n
Address line 2
Address line 3
CityJerez de la Frontera
Postcode
CountrySpain
Phone number (incl. country code)34617445704
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)LOPINAVIR/RITONAVIR
Single-Constituent (Substance INN)HYDROXYCHLOROQUINE SULFATE
Single-Constituent (Substance INN)Chloroquine
Single-Constituent (Substance INN)REMDESIVIR
Single-Constituent (Substance INN)INTERFERON BETA-1B
Single-Constituent (Substance INN)AZITHROMYCIN
Multi-Constituent (Substance INN(s))DARUNAVIR
COBICISTAT
Single-Constituent (Substance INN)FOSAMPRENAVIR
Multi-Constituent (Substance INN(s))DARUNAVIR
COBICISTAT
EMTRICITABINE
TENOFOVIR
Single-Constituent (Substance INN)TOCILIZUMAB
7. Medical conditions to be studied
Medical condition(s)Yes
Pneumonia
Additional Medical Condition(s)
SARS-CoV-2 infection
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
Other population
Renal impaired
Hepatic impaired
Immunocompromised
9. Number of subjects
Estimated total number of subjects10000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Disease/case registry
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Effectiveness evaluation
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To Evaluate the effectiveness of pharmacotherapy used in the treatment of cases of SARS-CoV2 coronavirus infection who have required hospital admission in Spain during the pandemic declared in March 2020.
Are there primary outcomes?Yes
Remission rate of the disease at 14 days (proportion, 95% CI), understanding remission as:
- Improvement of symptoms (fever, cough ...) together with radiological improvement and/or
- PaFi> o = 300 mm Hg or O2 saturations> 93 without O2 administration.
Are there secondary outcomes?No
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
14 days or discharge or death
15. Data analysis plan
Please provide a brief summary of the analysis method
Accordind the exceptional situation, no sample size has been calculated to achieve the primary objective. However, intermediate analyzes will be made based on the inclusion of completed cases (discharge / exitus or 14 days of treatment) every week. The beta error of each of the treatment groups will be calculated from each analysis cut to determine if the number of patients included is powerful enough to draw conclusions. At least a beta error of 20% (power of 80%) and an alpha error of 5% will be assumed.
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
