Coronavirus Infections Clinical Trial
— COVID-BioBOfficial 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
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
| Status | Recruiting |
| Enrollment | 6000 |
| Est. completion date | March 19, 2025 |
| Est. primary completion date | March 19, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute | Milan | Lombardy |
| Italy | Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute | Milan | Lombardy |
| Italy | Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - | Milan | Lombardy |
| Italy | Department of Internal Medicine - IRCCS San Raffaele Scientific Institute | Milan | Lombardy |
| Italy | Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute | Milan | Lombardy |
| Italy | Division of Immunology, Transplantation and Infectious 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 | Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute | Milan | Lombardy |
| Italy | Unit of Immunology, Rheumatology, Allergy and Rare Diseases - 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Università Vita-Salute San Raffaele |
Italy,
Ciceri F, Beretta L, Scandroglio AM, Colombo S, Landoni G, Ruggeri A, Peccatori J, D'Angelo A, De Cobelli F, Rovere-Querini P, Tresoldi M, Dagna L, Zangrillo A. Microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome (MicroCLOTS): an atypical acute respiratory distress syndrome working hypothesis. Crit Care Resusc. 2020 Apr 15;22(2):95-97. doi: 10.51893/2020.2.pov2. Online ahead of print. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response | 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) |
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