Study identification

PURI

https://redirect.ema.europa.eu/resource/36203

EU PAS number

EUPAS34497

Study ID

36203

Official title and acronym

Hydroxychloroquine 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

DARWIN EU® study

No

Study countries

Germany
Japan
Netherlands
Spain
United Kingdom
United States

Study description

The overarching objective is to investigate safety and potential efficacy as an antiviral prophylaxis in light of potential wide-spread use in COVID-19

Study status

Finalised
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
Columbia University US, Erasmus MC Netherlands, SIDIAP Spain, UCLA US, Janssen Research and Development UK

Networks

Contact details

Daniel Prieto-Alhambra

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme

More details on funding

IMI2 - EHDEN
Study protocol
Initial protocol

PLE_HCQ_Protocol

English (764.57 KB - PDF)View document
Updated protocol

PLE_HCQ_Protocol_1.6

English (849.78 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable