EFFECTIVENESS AND SAFETY OF TOCILIZUMAB IN INTERSTITIAL PNEUMONIA WITH SERIOUS RESPIRATORY FAILURE SECONDARY TO SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (TOCICOV-19)

Study identification

• EU PAS number:
  EUPAS34415
• Study ID:
  45837
• Official title and acronym:
  EFFECTIVENESS AND SAFETY OF TOCILIZUMAB IN INTERSTITIAL PNEUMONIA WITH SERIOUS RESPIRATORY FAILURE SECONDARY TO SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (TOCICOV-19)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This is a prospective multi-center cohort post-authorization drug study. A percentage of the patients included in this cohort will be recruited retrospectively, therefore, the overall study design is ambispective. From the patients admitted to the hospital for COVID-19 with a diagnosis of interstitial pneumonia with severe respiratory failure, two cohorts will be selected based on their exposure (or not) to treatment with tocilizumab. The study will be carried out under real healthcare conditions. Data will be collected from days 1, 3, 7, 15 and 28 post inclusion (or treatment)
• Study status:
  Finalised

Research institutions and networks

Institutions

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

Spain

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

Spain

HOSPITAL UNIVERSITARIO DE PUERTO REAL Spain, HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO Spain, HOSPITAL UNIVERSITARIO TORRECÁRDENAS Spain, HOSPITAL UNIV. GERMANS TRIAS I PUJOL Spain, HOSPITAL DEL MAR- PARC DE SALUT MAR Spain, HOSPITAL DE LA SANTA CREU I SANT PAU Spain, HOSPITAL UNIVERSITARIO DE CANARIAS Spain, HOSPITAL UNIVERSITARIO Nra Sra. CANDELARIA/ C.H. UNIV. DE SANTIAGO DE COMPOSTELA Spain, HOSPITAL UNIVERSITARI DE BELLVITGE/ HOSPITAL UNIVERSITARIO GREGORIO MARAÑON/HOSPITAL UNIVERSITARIO CLÍNICO SAN CARLOS/ HOSPITAL UNIVERSITARIO RAMÓN Y CAJAL Spain, HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA/ HOSPITAL INFANTA CRISTINA BADAJOZ/ HOSPITAL DE CÁCERES/ HOSPITAL UNIVERSITARIO DE LA PRINCESA/ HOSPITAL CENTRAL DE LA DEFENSA GÓMEZ ULLA Spain

Study timelines

Date when funding contract was signed

Planned:03/04/2020

Actual:06/04/2020

Study start date

Planned:09/04/2020

Actual:10/04/2020

Data analysis start date

Planned:23/04/2020

Date of interim report, if expected

Planned:01/05/2020

Date of final study report

Planned:15/05/2020

Actual:07/09/2020

Sources of funding

Other

More details on funding

Own funds

Regulatory

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