Study identification

PURI

https://redirect.ema.europa.eu/resource/43811

EU PAS number

EUPAS43810

Study ID

43811

Official title and acronym

Risk of Herpes Zoster in individuals diagnosed with COVID19 infection in the Valencia region of Spain: a retrospective cohort population-based study (AIV_HZ_2021_05_COVIDHZ_AOS)

DARWIN EU® study

No

Study countries

Spain

Study description

Based on the potential association between SARS-CoV-2 and HZ, we propose here a study to estimate the risk of HZ in subjects with SARS-CoV-2 infection using Real World Data (RWD). This population-based retrospective dynamic cohort study (meaning that members can leave or be added over time) will be based on eHR databases/registries from the Valencia Region (Valencia 7 Health System Integrated Database (VID) (27). VID allows linking socio-demographic, inpatients, outpatients, specialists, medication, and microbiology databases (among others) at individual level. The study population will consist of all population covered by the Public Health System (over 98%), representing about 5 million persons. As of March 8th, 2021, more than 381,919 confirmed cases of SARS-CoV-2 have been registered in the Valencian Community (4). Together with the VID makes the region of Valencia the ideal candidate to test the proposed hypothesis.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Alejandro Orrico-Sánchez

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GSK
Study protocol
Initial protocol

PROTOCOL_AIV_V5.0

English (1.06 MB - 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