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

Sponsor
Università Vita-Salute San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT04318366
Collaborator
(none)
6,000
13
36
461.5
12.8

Study Details

Study Description

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 Phase
  • Other: Observational Study

Study Design

Study Type:
Observational
Anticipated Enrollment :
6000 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 :
Mar 19, 2020
Anticipated Primary Completion Date :
Mar 19, 2023
Anticipated Study Completion Date :
Mar 19, 2023

Arms and Interventions

Arm Intervention/Treatment
COVID-19 patients

Other: Observational Study
Not required

Outcome Measures

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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 2012
2 AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 20132
3 Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - Milan Lombardy Italy 20132
4 Department of Internal Medicine - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 20132
5 Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute Milan Lombardy Italy 20132
6 Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 20132
7 Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute Milan Lombardy Italy 20132
8 Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 20132
9 Nephrology Unit - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 20132
10 Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 20132
11 Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute Milan Lombardy Italy 20132
12 Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute Milan Lombardy Italy 2132
13 Università Vita-Salute San Raffaele Milano Mi Italy 20132

Sponsors and Collaborators

  • Università Vita-Salute San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

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:
Mar 24, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022