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

Recruiting

• Conditions: Coronavirus Infections
• Interventions: Other: Observational Study

• Registration Number: NCT04318366
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-19
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-03-19
• Study Completion: 2026-03-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients	Observational Study	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Lombardy, Italy

Department of Internal Medicine - IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Lombardy, Italy

AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Lombardy, Italy

Department of Infection 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

Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Lombardy, Italy

Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Lombardy, Italy

Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute; 🇮🇹 Milan, Lombardy, Italy

Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Lombardy, Italy

Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute; 🇮🇹 Milan, Lombardy, Italy

Università Vita-Salute San Raffaele; 🇮🇹 Milano, Mi, Italy