Clinical trial Recruiting at 13 sites Observational Ages 18 and up

Characterizing COVID-19 patients to predict treatment outcomes

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

Run by Università Vita-Salute San Raffaele · NCT04318366 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment6000 (estimated)
SponsorUniversità Vita-Salute San Raffaele
Academic / other
Locations13 sites (Milan, Lombardy and 12 other locations)
StatusRecruiting
StartedMarch 19, 2020
Main results expectedJune 19, 2026
Study endsJune 19, 2026
Registry record updatedMay 8, 2026
Trial IDNCT04318366 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

Patients with mild symptoms not requiring hospitalization may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
Show 7 more locations
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Evaluating Baricitinib for Long COVID Symptoms

    This study is testing if the medication baricitinib can help adults with Long COVID feel better physically and mentally compared to a placebo.

    Recruiting at 17 sites Phase 3 Vanderbilt University Medical Center · Tucson, Arizona and 16 other locations · NCT06631287

  • Examining the incidence of COVID-19 infections

    This study is trying to see how common COVID-19 infections are and how air pollution affects people's immune responses and health during the reopening phase after lockdowns.

    Recruiting Centre Hospitalier Universitaire de Nice · Nice · NCT04429594

  • In-depth investigation of the immune response to COVID-19

    This study looks at the immune responses of hospitalized COVID-19 patients to see what makes some people get sicker than others.

    Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT04327570

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.