Status: Finalised First registered on: 03/04/2020
Last updated on: 06/07/2020
1. Study identification
EU PAS Register NumberEUPAS34497
Official titleHydroxychloroquine safety and potential efficacy as an antiviral prophylaxis in light of potential wide-spread use in COVID-19: a multinational, large-scale network cohort and self-controlled case series study
Study title acronym
Study typeObservational study
Brief description of the studyThe overarching objective is to investigate safety and potential efficacy as an antiviral prophylaxis in light of potential wide-spread use in COVID-19
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 nameUniversity of Oxford
Centre locationUnited Kingdom
Details of (Primary) lead investigator
Title Professor
Last name Prieto-Alhambra
First name Daniel
Is this study being carried out with the collaboration of a research network?
Yes
OHDSI- Observational Health Data Sciences and Informatics
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

IDIAPJGol
IQVIA
Columbia University, US
Erasmus MC, Netherlands
SIDIAP, Spain
UCLA, US
Janssen Research and Development, UK
Countries in which this study is being conducted
International study

Germany
Japan
Netherlands
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed22/11/201822/11/2018
Start date of data collection01/09/200001/09/2000
Start date of data analysis01/03/202001/03/2020
Date of interim report, if expected14/04/2020
Date of final study report30/05/202030/05/2020
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 schemeIMI2 - EHDEN100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Prieto-Alhambra
First name Daniel
Address line 1Botnar Research Cenre
Address line 2Nuffield Orthopaedic Centre 
Address line 3Windmill Road 
CityOxford 
PostcodeOX4 2AP 
CountryUnited Kingdom
Phone number (incl. country code)00441865223401 
Alternative phone number 
Fax number (incl. country code) 
Email address daniel.prietoalhambra@ndorms.ox.ac.uk
Public Enquiries
Title Professor 
Last name Prieto-Alhambra 
First name Daniel 
Address line 1Botnar Research Cenre 
Address line 2Nuffield Orthopaedic Centre 
Address line 3Windmill Road 
CityOxford 
PostcodeOX4 2AP 
CountryUnited Kingdom 
Phone number (incl. country code)00441865223401 
Alternative phone number 
Fax number (incl. country code) 
Email address daniel.prietoalhambra@ndorms.ox.ac.uk 
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