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RecruitingNCT04318366COVID-BioBUpdated May 8, 2026

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

An observational study in Coronavirus Infections, sponsored by Università Vita-Salute San Raffaele. Recruiting at 13 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Università Vita-Salute San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Coronavirus Infections
03

In context

Coronavirus Infections

1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 308 across 387 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COVID-19 patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • COVID-19 patients

    Other: Observational Study

Interventions

  • OtherObservational Study

    Not required

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Hospital stay (2-3 weeks)

07

Study locations

13 of 13 sites recruiting
  • Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 2012, Italy
    Recruiting
    • Angelo AM Manfredi, Prof · Contact
  • AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Giudo Poli, Prof · Contact
  • Department of Infection Diseases - IRCCS San Raffaele Scientific Institute -
    Milan, Lombardy 20132, Italy
    Recruiting
    • Adriano Lazzarin, Prof · Contact
    • Antonella Castagna, Prof · Sub investigator
    • Paolo Scarpellini, Dr · Sub investigator
    • Andrea Poli, Ing · Sub investigator
  • Department of Internal Medicine - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Emanuele Bosi, Prof · Contact
    • Patrizia Rovere Querini, Prof · Sub investigator
  • Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Lorenzo Piemonti, Prof · Contact
  • Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Chiara Bonini, Prof · Contact
  • Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Fabio Ciceri, Prof · Contact
  • Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Massimo Clementi, Prof · Contact
    • Nicasio Mancini, Prof · Sub investigator
  • Nephrology Unit - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Chiara Lanzani, Dr · Contact
  • Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Paolo Manunta, Prof · Contact
  • Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute
    Milan, Lombardy 20132, Italy
    Recruiting
    • Elisa Vicenzi, Dr · Contact
  • Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute
    Milan, Lombardy 2132, Italy
    Recruiting
    • Lorenzo Dagna, Prof · Contact
    • Moreno Tresoldi, Dr · Sub investigator
  • Università Vita-Salute San Raffaele
    Milan, Mi 20132, Italy
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32294809 ↗
  • 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. PubMed 38381905 ↗
  • 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. PubMed 38045523 ↗
  • 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. PubMed 37053376 ↗
  • 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. PubMed 35464004 ↗
  • 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. PubMed 35000058 ↗
  • 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. PubMed 34059384 ↗
  • 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. PubMed 34002039 ↗
  • 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. PubMed 33627313 ↗
  • 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. PubMed 33160700 ↗
  • 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. PubMed 32991329 ↗
  • 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. PubMed 32945968 ↗
  • 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. PubMed 32900326 ↗
  • 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. PubMed 32675217 ↗
  • 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. PubMed 32501454 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04318366
Lead sponsor
Università Vita-Salute San Raffaele
Responsible party
Giovanni Landoni (MD, Associate Professor, Università Vita-Salute San Raffaele) — Principal investigator
First posted
Mar 24, 2020
Start date
Mar 19, 2020
Primary completion
Jun 19, 2026 (estimated)
Completion
Jun 19, 2026 (estimated)
Last update
May 8, 2026

Study contacts

Giovanni Landoni, Professor
Contact
landoni.giovanni@hsr.it
+390226436151
Alberto Zangrillo, Professor
Contact
zangrillo.alberto@hsr.it
+390226436151

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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