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AzTrials

Coronavirus InfectionsCOVID-BioBNCT04318366

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

An observational study of Coronavirus Infections, run by Università Vita-Salute San Raffaele at 13 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infections
What is being tested?
Observational Study
How many people
6,000 participants
Where
13 sitesItaly
Study dates
19 Mar 2020to 19 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COVID-19 patients

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Giovanni Landoni, Professor contact

+390226436151

landoni.giovanni@hsr.it

Alberto Zangrillo, Professor contact

+390226436151

zangrillo.alberto@hsr.it

13 sites in 1 country

Italy13 sites, 13 recruiting
  • Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 2012

    Angelo AM Manfredi, Prof

    Recruiting
  • AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 20132

    Giudo Poli, Prof

    Recruiting
  • Department of Infection Diseases - IRCCS San Raffaele Scientific Institute -

    Milan, Lombardy, 20132

    Adriano Lazzarin, Prof

    Antonella Castagna, Prof

    Recruiting
  • Department of Internal Medicine - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 20132

    Emanuele Bosi, Prof

    Patrizia Rovere Querini, Prof

    Recruiting
  • Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute

    Milan, Lombardy, 20132

    Lorenzo Piemonti, Prof

    Recruiting
  • Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 20132

    Chiara Bonini, Prof

    Recruiting
  • Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute

    Milan, Lombardy, 20132

    Fabio Ciceri, Prof

    Recruiting
  • Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 20132

    Massimo Clementi, Prof

    Nicasio Mancini, Prof

    Recruiting
  • Nephrology Unit - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 20132

    Chiara Lanzani, Dr

    Recruiting
  • Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 20132

    Paolo Manunta, Prof

    Recruiting
  • Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute

    Milan, Lombardy, 20132

    Elisa Vicenzi, Dr

    Recruiting
  • Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute

    Milan, Lombardy, 2132

    Lorenzo Dagna, Prof

    Moreno Tresoldi, Dr

    Recruiting
  • Università Vita-Salute San Raffaele

    Milan, Mi, 20132

    Giovanni Landoni, Professor, landoni.giovanni@hsr.it

    Alberto Zangrillo, Professor, zangrillo.alberto@hsr.it

    Recruiting

Other trials in Italy

About this study

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

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

Being tested
Observational Study
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational StudyOther

    Not required

Study groups in NCT04318366
Study groupRoleWhat they receive
COVID-19 patientsNot described
Receives: Other: Observational Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Hospital stay (2-3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2020
  2. Study start19 Mar 2020
  3. Primary completion19 Jun 2026 (estimated)
  4. Study completion19 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04318366
Sponsor's protocol ID
COVID-BioB/OSR
Acronym
COVID-BioB
Status last verified
May 2026
First submitted
19 Mar 2020
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Infections, run by Università Vita-Salute San Raffaele at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giovanni Landoni, Professor (+390226436151, landoni.giovanni@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04318366, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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