Association of ACE inhibitors and AT1R blockers and prognosis in hospitalized COVID-19 patients: a cohort study in Italy (ITA-COVID: RAS INHIBITORS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35260
• EU PAS number:
  EUPAS34541
• Study ID:
  35260
• Official title and acronym:
  Association of ACE inhibitors and AT1R blockers and prognosis in hospitalized COVID-19 patients: a cohort study in Italy (ITA-COVID: RAS INHIBITORS)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This observational study will use Italian claims databases from 5 catchment areas (Lombardy, Veneto and Lazio Regions as well as Modena and Reggio Emilia Local Health Unit) linked to COVID-19 patient registries in the same catchment areas. The aim of the study is to evaluate whether treatment with ACE-inhibitors or angiotension receptor blockers modifies the clinical progression or prognosis of patients infected with COVID-19 who have been hospitalised.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacoepidemiology Unit - National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità (ISS)

Italy

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/03/2020

Actual: 31/03/2020

Study start date

Planned: 15/04/2020

Actual: 31/03/2020

Date of interim report, if expected

Planned: 15/05/2020

Date of final study report

Planned: 30/05/2020

Actual: 30/04/2020

Sources of funding

Other

More details on funding

Self-funded

Study protocol

Initial protocol

Protocollo studio ISS_english_ENCePP_redacted

Regulatory

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