Study identification

PURI

https://redirect.ema.europa.eu/resource/45837

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

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

Contact details

Belen Ruiz-Antoran

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Own funds
Study protocol
Initial protocol

PROTOCOLO ESTUDIO DE COHORTES TOCI VERSION 0_REV

English (866.64 KB - PDF)View document
Updated protocol

PROTOCOLO ESTUDIO DE COHORTES TOCI VERSION 1.0 08042020

English (403.65 KB - 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