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Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Trial Profile

Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 03 Jul 2020

At a glance

  • Drugs Sarilumab (Primary) ; Antivirals; Azithromycin; Hydroxychloroquine; Lopinavir/ritonavir
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Acronyms COVID-BioB
  • Most Recent Events

    • 03 Jul 2020 Results (n=56) published in the Annals of the Rheumatic Diseases
    • 09 Apr 2020 New trial record

Trial Overview

Purpose

Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions

Primary Endpoints

Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

description: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response
time_frame: Hospital stay (2-3 weeks)

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 1000

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

- Patients admitted to hospital with biological samples positive for SARS-CoV-2 - Patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of SARS-CoV-2 disease - Patients discharged from emergency department with biological samples positive for SARS-CoV-2

Patient Exclusion Criteria

- None

Trial Details

Identifiers

Identifier Owner
NCT04318366 ClinicalTrials.gov: US National Institutes of Health
COVID-BioB-OSR -

Trial Dates

  • Initiation Dates

    Actual : 19 Mar 2020

  • Primary Completion Dates

    Planned : 19 Mar 2022

  • End Dates

    Planned : 19 Mar 2022

Other Details

  • Design cohort; multicentre; observational; open; prospective
  • Phase of Trial Phase IV
  • Location Italy
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Antivirals
-
-
Azithromycin
-
-
Hydroxychloroquine Oral
-
Lopinavir/ritonavir Oral
-
SarilumabPrimary Drug Intravenous Infusion

COVID-19 patients

Other: Observational Study (Not required)

Results

Publications

  1. Della-Torre E, Campochiaro C, Cavalli G, De Luca G, Napolitano A, La Marca S, et al. Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study. . Ann-Rheum-Dis 2020;.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Boffini N 1 - -
Campochiaro C 1 - -
Cavalli G 1 - -
Ciceri F 1 - -
Da Prat V 1 - -
Dagna L 1 - 1
De Cobelli F 1 - -
De Luca G 1 - -
Della-Torre E 1 1 -
Di Terlizzi G 1 - -
La Marca S 1 - -
Landoni G 1 - -
Lanzillotta M 1 - -
Napolitano A 1 - -
Rovere Querini P 1 - -
Ruggeri A 1 - -
Tresoldi M 1 - -
Zangrillo A 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Adriano Lazzarin, Prof Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Italy
Alberto Zangrillo, Professor
zangrillo.alberto@hsr.it
+390226436151
show details
Università Vita-Salute San Raffaele Italy
Andrea Poli, Ing Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Italy
Angelo AM Manfredi, Prof Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute Italy
Antonella Castagna, Prof Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Italy
Chiara Bonini, Prof Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute Italy
Chiara Lanzani, Dr Nephrology Unit - IRCCS San Raffaele Scientific Institute Italy
Elisa Vicenzi, Dr Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute Italy
Emanuele Bosi, Prof Department of Internal Medicine - IRCCS San Raffaele Scientific Institute Italy
Fabio Ciceri, Prof Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute Italy
Giovanni Landoni, Professor
+390226436151
landoni.giovanni@hsr.it
show details
-
Giudo Poli, Prof AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute Italy
Lorenzo Dagna, Prof Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute Italy
Lorenzo Piemonti, Prof Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute Italy
Massimo Clementi, Prof Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute Italy
Moreno Tresoldi, Dr Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute Italy
Nicasio Mancini, Prof Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute Italy
Paolo Manunta, Prof Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute Italy
Paolo Scarpellini, Dr Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Italy
Patrizia Rovere Querini, Prof Department of Internal Medicine - IRCCS San Raffaele Scientific Institute Italy

Centres

Centre Name Location Trial Centre Country
-
-
-
AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Milan, Lombardy Italy
Department of Internal Medicine - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute Milan, Lombardy Italy
Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute Milan, Lombardy Italy
Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Nephrology Unit - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute Milan, Lombardy Italy
Università Vita-Salute San Raffaele
-
-
Università Vita-Salute San Raffaele Milano, Mi Italy
Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute Milan, Lombardy Italy

Trial History

Event Date Event Type Comment
03 Jul 2020 Results Results (n=56) published in the Annals of the Rheumatic Diseases Updated 16 Jul 2020
09 Apr 2020 New trial record New trial record Updated 09 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Della-Torre E, Campochiaro C, Cavalli G, De Luca G, Napolitano A, La Marca S, et al. Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study. . Ann-Rheum-Dis 2020;.

    PubMed | CrossRef Fulltext
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