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

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 institutions and networks

Institutions

National Perinatal Epidemiology Unit (NPEU), University of Oxford

United Kingdom

IQVIA

United Kingdom

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Columbia University US, Erasmus MC Netherlands, SIDIAP Spain, UCLA US, Janssen Research and Development UK

Networks

Observational Health Data Sciences and Informatics (OHDSI) Network

Study timelines

Date when funding contract was signed

Planned: 22/11/2018

Actual: 22/11/2018

Study start date

Planned: 01/09/2000

Actual: 01/09/2000

Data analysis start date

Planned: 01/03/2020

Actual: 01/03/2020

Date of interim report, if expected

Planned: 14/04/2020

Date of final study report

Planned: 30/05/2020

Actual: 30/05/2020

Sources of funding

EU institutional research programme

More details on funding

IMI2 - EHDEN

Study protocol

Initial protocol

PLE_HCQ_Protocol

Updated protocol

PLE_HCQ_Protocol_1.6

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable