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COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor (COVID-BioB)

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ClinicalTrials.gov Identifier: NCT04318366
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

Brief Summary:
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

Condition or disease Intervention/treatment
Coronavirus Infections Other: Observational Study

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : March 19, 2022
Estimated Study Completion Date : March 19, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID-19 patients Other: Observational Study
Not required




Primary Outcome Measures :
  1. 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) ]
    Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 patients
Criteria

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318366


Contacts
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Contact: Giovanni Landoni, Professor +390226436151 landoni.giovanni@hsr.it
Contact: Alberto Zangrillo, Professor +390226436151 zangrillo.alberto@hsr.it

Locations
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Italy
Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 2012
Contact: Angelo AM Manfredi, Prof         
AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Giudo Poli, Prof         
Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Recruiting
Milan, Lombardy, Italy, 20132
Contact: Adriano Lazzarin, Prof         
Sub-Investigator: Antonella Castagna, Prof         
Sub-Investigator: Paolo Scarpellini, Dr         
Sub-Investigator: Andrea Poli, Ing         
Department of Internal Medicine - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Emanuele Bosi, Prof         
Sub-Investigator: Patrizia Rovere Querini, Prof         
Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Lorenzo Piemonti, Prof         
Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Chiara Bonini, Prof         
Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Fabio Ciceri, Prof         
Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Massimo Clementi, Prof         
Sub-Investigator: Nicasio Mancini, Prof         
Nephrology Unit - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Chiara Lanzani, Dr         
Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Paolo Manunta, Prof         
Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute Recruiting
Milan, Lombardy, Italy, 20132
Contact: Elisa Vicenzi, Dr         
Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute Recruiting
Milan, Lombardy, Italy, 2132
Contact: Lorenzo Dagna, Prof         
Sub-Investigator: Moreno Tresoldi, Dr         
Università Vita-Salute San Raffaele Recruiting
Milano, Mi, Italy, 20132
Contact: Giovanni Landoni, Professor       landoni.giovanni@hsr.it   
Contact: Alberto Zangrillo, Professor       zangrillo.alberto@hsr.it   
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT04318366    
Other Study ID Numbers: COVID-BioB/OSR
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases