Status: Ongoing First registered on: 31/03/2020
Last updated on: 15/09/2020
1. Study identification
EU PAS Register NumberEUPAS34415
Official titleEFFECTIVENESS AND SAFETY OF TOCILIZUMAB IN INTERSTITIAL PNEUMONIA WITH SERIOUS RESPIRATORY FAILURE SECONDARY TO SARS-COV-2 INFECTION (COVID-19): COHORT STUDY
Study title acronymTOCICOV-19
Study typeObservational study
Brief description of the studyThis 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)
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsClinical Pharmacology Service HUPHM
Department/Research groupClinical Pharmacology Service
Organisation/affiliationPuerta de Hierro-Majadahonda University Hospital
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name Ruiz-Antoran
First name Belen
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?22

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
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/04/202006/04/2020
Start date of data collection09/04/202010/04/2020
Start date of data analysis23/04/2020
Date of interim report, if expected01/05/2020
Date of final study report15/05/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherOwn funds100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ruiz-Antoran
First name Belen
Address line 1Manuel de Falla 1.
Address line 2 
Address line 3 
CityMadrid 
Postcode28222 
CountrySpain
Phone number (incl. country code)0034911916481 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Ruiz-Antoran 
First name Belen 
Address line 1Manuel de Falla 1. 
Address line 2 
Address line 3 
CityMadrid 
Postcode28222 
CountrySpain 
Phone number (incl. country code)0034911916481 
Alternative phone number 
Fax number (incl. country code) 
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