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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: 09 Apr 2020

At a glance

  • Drugs Defibrotide (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms COVID-BioB
  • Most Recent Events

    • 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 -

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; prospective
  • Phase of Trial Phase IV
  • Location Italy
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
DefibrotidePrimary Drug Intravenous Infusion

COVID-19 patients

Other: Observational Study (Not required)

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
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-
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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
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
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