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

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

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infections
• Intervention / Treatment: Other: Observational Study

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Giovanni Landoni, Professor; Phone Number: +390226436151; Email: landoni.giovanni@hsr.it
• Study Contact Backup: Name: Alberto Zangrillo, Professor; Phone Number: +390226436151; Email: zangrillo.alberto@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 2012
      • Recruiting
      • Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute
      • Contact: Angelo AM Manfredi, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute
      • Contact: Giudo Poli, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Department of Infection Diseases - IRCCS San Raffaele Scientific Institute -
      • Contact: Adriano Lazzarin, Prof
      • Sub-Investigator: Antonella Castagna, Prof
      • Sub-Investigator: Paolo Scarpellini, Dr
      • Sub-Investigator: Andrea Poli, Ing
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Department of Internal Medicine - IRCCS San Raffaele Scientific Institute
      • Contact: Emanuele Bosi, Prof
      • Sub-Investigator: Patrizia Rovere Querini, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute
      • Contact: Lorenzo Piemonti, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute
      • Contact: Chiara Bonini, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute
      • Contact: Fabio Ciceri, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute
      • Contact: Massimo Clementi, Prof
      • Sub-Investigator: Nicasio Mancini, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Nephrology Unit - IRCCS San Raffaele Scientific Institute
      • Contact: Chiara Lanzani, Dr
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute
      • Contact: Paolo Manunta, Prof
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute
      • Contact: Elisa Vicenzi, Dr
    • Milan, Lombardy, Italy, 2132
      • Recruiting
      • Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute
      • Contact: Lorenzo Dagna, Prof
      • Sub-Investigator: Moreno Tresoldi, Dr
  • Mi
    • Milan, Mi, Italy, 20132
      • Recruiting
      • Università Vita-Salute San Raffaele
      • Contact: Giovanni Landoni, Professor; Email: landoni.giovanni@hsr.it
      • Contact: Alberto Zangrillo, Professor; Email: zangrillo.alberto@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 patients	Other: Observational Study; Not required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Publications and helpful links

General Publications

• De Lorenzo R, Palmisano A, Esposito A, Gnasso C, Nicoletti V, Leone R, Vignale D, Falbo E, Ferrante M, Cilla M, Magnaghi C, Martinenghi S, Vitali G, Molfino A, Rovere-Querini P, Muscaritoli M, Conte C. Myosteatosis Significantly Predicts Persistent Dyspnea and Mobility Problems in COVID-19 Survivors. Front Nutr. 2022 Apr 8;9:846901. doi: 10.3389/fnut.2022.846901. eCollection 2022.
• Dispinseri S, Marzinotto I, Brigatti C, Pirillo MF, Tolazzi M, Bazzigaluppi E, Canitano A, Borghi M, Gallinaro A, Caccia R, Vercesi R, McKay PF, Ciceri F, Piemonti L, Negri D, Cinque P, Cara A, Scarlatti G, Lampasona V. Seasonal Betacoronavirus Antibodies' Expansion Post-BNT161b2 Vaccination Associates with Reduced SARS-CoV-2 VoC Neutralization. J Clin Immunol. 2022 Apr;42(3):448-458. doi: 10.1007/s10875-021-01190-5. Epub 2022 Jan 9.
• Conte C, Esposito A, De Lorenzo R, Di Filippo L, Palmisano A, Vignale D, Leone R, Nicoletti V, Ruggeri A, Gallone G, Secchi A, Bosi E, Tresoldi M, Castagna A, Landoni G, Zangrillo A, De Cobelli F, Ciceri F, Camici P, Rovere-Querini P. Epicardial adipose tissue characteristics, obesity and clinical outcomes in COVID-19: A post-hoc analysis of a prospective cohort study. Nutr Metab Cardiovasc Dis. 2021 Jun 30;31(7):2156-2164. doi: 10.1016/j.numecd.2021.04.020. Epub 2021 May 3.
• Di Filippo L, De Lorenzo R, Cinel E, Falbo E, Ferrante M, Cilla M, Martinenghi S, Vitali G, Bosi E, Giustina A, Rovere-Querini P, Conte C. Weight trajectories and abdominal adiposity in COVID-19 survivors with overweight/obesity. Int J Obes (Lond). 2021 Sep;45(9):1986-1994. doi: 10.1038/s41366-021-00861-y. Epub 2021 May 17.
• Vanella G, Capurso G, Burti C, Fanti L, Ricciardiello L, Souza Lino A, Boskoski I, Bronswijk M, Tyberg A, Krishna Kumar Nair G, Angeletti S, Mauro A, Zingone F, Oppong KW, de la Iglesia-Garcia D, Pouillon L, Papanikolaou IS, Fracasso P, Ciceri F, Rovere-Querini P, Tomba C, Viale E, Eusebi LH, Riccioni ME, van der Merwe S, Shahid H, Sarkar A, Yoo JWG, Dilaghi E, Speight RA, Azzolini F, Buttitta F, Porcari S, Petrone MC, Iglesias-Garcia J, Savarino EV, Di Sabatino A, Di Giulio E, Farrell JJ, Kahaleh M, Roelandt P, Costamagna G, Artifon ELA, Bazzoli F, Testoni PA, Greco S, Arcidiacono PG. Gastrointestinal mucosal damage in patients with COVID-19 undergoing endoscopy: an international multicentre study. BMJ Open Gastroenterol. 2021 Feb;8(1):e000578. doi: 10.1136/bmjgast-2020-000578.
• Di Filippo L, De Lorenzo R, D'Amico M, Sofia V, Roveri L, Mele R, Saibene A, Rovere-Querini P, Conte C. COVID-19 is associated with clinically significant weight loss and risk of malnutrition, independent of hospitalisation: A post-hoc analysis of a prospective cohort study. Clin Nutr. 2021 Apr;40(4):2420-2426. doi: 10.1016/j.clnu.2020.10.043. Epub 2020 Oct 29.
• Secchi M, Bazzigaluppi E, Brigatti C, Marzinotto I, Tresoldi C, Rovere-Querini P, Poli A, Castagna A, Scarlatti G, Zangrillo A, Ciceri F, Piemonti L, Lampasona V. COVID-19 survival associates with the immunoglobulin response to the SARS-CoV-2 spike receptor binding domain. J Clin Invest. 2020 Dec 1;130(12):6366-6378. doi: 10.1172/JCI142804.
• Mushtaq J, Pennella R, Lavalle S, Colarieti A, Steidler S, Martinenghi CMA, Palumbo D, Esposito A, Rovere-Querini P, Tresoldi M, Landoni G, Ciceri F, Zangrillo A, De Cobelli F. Initial chest radiographs and artificial intelligence (AI) predict clinical outcomes in COVID-19 patients: analysis of 697 Italian patients. Eur Radiol. 2021 Mar;31(3):1770-1779. doi: 10.1007/s00330-020-07269-8. Epub 2020 Sep 18.
• Pagnesi M, Baldetti L, Beneduce A, Calvo F, Gramegna M, Pazzanese V, Ingallina G, Napolano A, Finazzi R, Ruggeri A, Ajello S, Melisurgo G, Camici PG, Scarpellini P, Tresoldi M, Landoni G, Ciceri F, Scandroglio AM, Agricola E, Cappelletti AM. Pulmonary hypertension and right ventricular involvement in hospitalised patients with COVID-19. Heart. 2020 Sep;106(17):1324-1331. doi: 10.1136/heartjnl-2020-317355. Epub 2020 Jul 16.
• Cavalli G, De Luca G, Campochiaro C, Della-Torre E, Ripa M, Canetti D, Oltolini C, Castiglioni B, Tassan Din C, Boffini N, Tomelleri A, Farina N, Ruggeri A, Rovere-Querini P, Di Lucca G, Martinenghi S, Scotti R, Tresoldi M, Ciceri F, Landoni G, Zangrillo A, Scarpellini P, Dagna L. Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study. Lancet Rheumatol. 2020 Jun;2(6):e325-e331. doi: 10.1016/S2665-9913(20)30127-2. Epub 2020 May 7.
• 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.
• Zangrillo A, Beretta L, Scandroglio AM, Monti G, Fominskiy E, Colombo S, Morselli F, Belletti A, Silvani P, Crivellari M, Monaco F, Azzolini ML, Reineke R, Nardelli P, Sartorelli M, Votta CD, Ruggeri A, Ciceri F, De Cobelli F, Tresoldi M, Dagna L, Rovere-Querini P, Serpa Neto A, Bellomo R, Landoni G; COVID-BioB Study Group. Characteristics, treatment, outcomes and cause of death of invasively ventilated patients with COVID-19 ARDS in Milan, Italy. Crit Care Resusc. 2020 Sep;22(3):200-211. doi: 10.1016/S1441-2772(23)00387-3.
• Merolla A, De Lorenzo R, Paolazzi G, Critelli S, Palladini M, Damanti S, Vitali G, Canti V, Cilla M, Martinenghi S, Falbo E, Ferrante M, Castellani J, Pacioni G, Magnaghi C, Fumagalli A, Mazza MG, Benedetti F, Rovere-Querini P. Micronized/ultramicronized palmitoylethanolamide improves depression and fatigue in coronavirus disease 2019 (COVID-19) survivors. Int Clin Psychopharmacol. 2024 Nov 1;39(6):361-368. doi: 10.1097/YIC.0000000000000537. Epub 2024 Feb 22.
• Zangrillo A, Colombo S, Scandroglio AM, Fominskiy E, Pieri M, Calabro MG, Beccaria PF, Pasculli N, Guzzo F, Calvi MR, Cipriani A, Sartini C, Nardelli P, Ortalda A, Lombardi G, Sartorelli M, Monti G, Assanelli A, Tresoldi M, Dagna L, Franchini S, Neto AS, Bellomo R, Landoni G. Angiotensin II infusion and markers of organ function in invasively ventilated COVID-19 patients. Crit Care Resusc. 2023 Oct 18;23(2):215-224. doi: 10.51893/2021.2.oa9. eCollection 2021 Jun.
• Negro A, Villa G, Cardinali M, Gianelle N, Ranzani R, Rolandi S, Maimeri N, Zangrillo A. Is Gastrointestinal Bleeding a Problem for COVID-19 Intensive Care Unit Patients? Gastroenterol Nurs. 2023 May-Jun 01;46(3):225-231. doi: 10.1097/SGA.0000000000000722. Epub 2023 Apr 11.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 19, 2026

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; Coronavirus Infections; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: COVID-BioB/OSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No