Status: Ongoing
First registered on:
12/05/2020
Last updated on:
24/06/2020
1. Study identification
EU PAS Register NumberEUPAS35254
Official titleA retrospective study to evaluate the clinical effectiveness and safety of treatments for Covid-19 hospitalised patients and to determine prognostic factors.
Study title acronymRAPID COVID-19
Study typeObservational study
Brief description of the studyRAPID COVID-19 (Retrospective Analysis of Potential Interventions and Determinants). This retrospective study aims to evaluate the clinical effectiveness and safety of various treatments and regimes and prognostic factors in hospitalised patients with COVID-19 in Spain.
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 belongsOXON
Department/Research groupOXON Epidemiology
Organisation/affiliationOXON Epidemiology Ltd.
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MRCP DPhil(Oxon)
First name Nawab
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 signed25/05/202019/05/2020
Start date of data collection25/05/202019/05/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report24/02/2021
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
OtherOXON Epidemiology100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Qizilbash MRCP DPhil(Oxon)
First name Nawab
Address line 1London School of Hygiene & Tropical Medicine
Address line 2Keppel Street
Address line 3
CityLondon
PostcodeWC1E 7HT
CountryUnited Kingdom
Phone number (incl. country code)34-913459395
Alternative phone number34-629846059
Fax number (incl. country code)34-913459394
Public Enquiries
Title Dr
Last name Castellano
First name Jose
Address line 1Pl. del Conde del Valle de SĂșchil, 16,
Address line 2
Address line 3
CityMadrid
Postcode28015
CountrySpain
Phone number (incl. country code)34-686013599
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)HYDROXYCHLOROQUINE
Single-Constituent (Substance INN)LOPINAVIR/RITONAVIR
Single-Constituent (Substance INN)AZITHROMYCIN
Single-Constituent (Substance INN)REMDESIVIR
Single-Constituent (Substance INN)INTERFERON ALFA
Single-Constituent (Substance INN)INTERFERON BETA
Single-Constituent (Substance INN)TOCILIZUMAB
Single-Constituent (Substance INN)SARILUMAB
Multi-Constituent (Substance INN(s))DARUNAVIR
COBICISTAT
Single-Constituent (Substance INN)SARS-CoV-2 convalescent plasma
7. Medical conditions to be studied
Medical condition(s)Yes
COVID-19
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
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects2000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Disease/case registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To compare in-hospital clinical status in patients with Covid-19 treated with standard care and various treatments and determine prognostic factors.
Are there primary outcomes?Yes
6-point ordinal scale at 14 days:
Are there secondary outcomes?Yes
6-point ordinal scale at 7 and 28 days;
In-hospital death at 28 days;
mechanical ventilation;
renal replacement therapy,
duration of hospitalization;
duration of ICU stay;
serious complications and serious adverse events
Prediction score
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
Patients will be followed up until the earlier of death or hospital discharge.
15. Data analysis plan
Please provide a brief summary of the analysis method
The primary analysis will use an ordered polytomous logistic regression model to assess 14 day in-hospital clinical status on a 6-point ordinal scale, with adjustments. Results will be presented as odds ratios
Secondary analysis of death at 28 days will use logistic regression, also with adjustments.
Multivariable ordered polytomous logistic regression will be used to determine key predictors of the primary ordinal scale outcome. Multivariable logistic regression will be used to determine key predictors of the secondary outcome of death at 28 days, mechanical ventilation and renal replacement therapy. The final predictive model will be converted into a clinician-friendly index.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
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
