EFFECTIVENESS AND SAFETY OF CORTICOSTEROIDS IN SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (CORTICOV-19)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37209
• EU PAS number:
  EUPAS34753
• Study ID:
  37209
• Official title and acronym:
  EFFECTIVENESS AND SAFETY OF CORTICOSTEROIDS IN SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (CORTICOV-19)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This is a retrospective cohort post-authorization drug study. From the patients admitted to the hospital for COVID-19 with a diagnosis of interstitial pneumonia, two cohorts will be selected based on their exposure (or not) to treatment with corticosteroids. The study will be carried out under real healthcare conditions,Data will be collected from days 1, 3 and 7 post inclusion (or treatment)
• Study status:
  Finalised

Research institutions and networks

Institutions

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Study timelines

Date when funding contract was signed

Planned: 13/04/2020

Actual: 13/04/2020

Study start date

Planned: 14/04/2020

Actual: 14/04/2020

Data analysis start date

Planned: 24/04/2020

Actual: 27/04/2020

Date of interim report, if expected

Planned: 30/04/2020

Actual: 04/05/2020

Date of final study report

Planned: 15/05/2020

Actual: 08/05/2020

Sources of funding

Other

More details on funding

Own funds

Study protocol

Initial protocol

PROTOCOLO V1.0 EFECTIVIDAD Y SEGURIDAD DE LOS CORTICOIDES EN LA INFECCIÓN POR SARS

Updated protocol

PROTOCOLO V2.0 EFECTIVIDAD Y SEGURIDAD DE LOS CORTICOIDES EN LA INFECCIÓN POR SARS

Regulatory

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