Characterizing COVID-19 patients to predict treatment outcomes

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

This study looks at COVID-19 patients to see if certain factors can help predict how severe their illness will be and how well they might respond to different treatments.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Università Vita-Salute San Raffaele (other)
• Locations: 13 sites (Milan, Lombardy and 12 other locations)
• Trial ID: NCT04318366 on ClinicalTrials.gov

What this trial studies

This observational study collects and analyzes demographic, clinical, radiographic, and laboratory data from COVID-19 patients to identify predictors of disease severity, mortality, and treatment response. The goal is to determine which subgroups of patients may benefit from specific therapeutic interventions. By examining both positive and clinically suggestive cases of SARS-CoV-2, the study aims to enhance understanding of the disease and improve patient management.

Who should consider this trial

Good fit: Ideal candidates include hospitalized patients with confirmed or highly suspected COVID-19 infection.

Not a fit: Patients with mild symptoms not requiring hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better-targeted treatments for COVID-19 patients based on their individual characteristics.

How similar studies have performed: Other studies have shown success in characterizing COVID-19 patients and identifying predictors of outcomes, making this approach promising.

Eligibility 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

Where this trial is running

Milan, Lombardy and 12 other locations

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

Study contacts

• Study coordinator: Giovanni Landoni, Professor

Conditions: Coronavirus Infections