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

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ClinicalTrials.gov Identifier: NCT04318366

Recruitment Status : Recruiting

First Posted : March 24, 2020

Last Update Posted : December 27, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Giovanni Landoni, Università Vita-Salute San Raffaele

Study Description

Brief 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

Condition or disease	Intervention/treatment
Coronavirus Infections	Other: Observational Study

Study Design

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Study Type :	Observational
Estimated Enrollment :	6000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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
Actual Study Start Date :	March 19, 2020
Estimated Primary Completion Date :	March 19, 2024
Estimated Study Completion Date :	March 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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) ]
Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

COVID-19 patients

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318366

Contacts

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

Locations

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

Sponsors and Collaborators

Università Vita-Salute San Raffaele

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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. Online ahead of print.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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Responsible Party:	Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:	NCT04318366
Other Study ID Numbers:	COVID-BioB/OSR
First Posted:	March 24, 2020 Key Record Dates
Last Update Posted:	December 27, 2022
Last Verified:	December 2022

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Infections Coronavirus Infections Coronaviridae Infections	Nidovirales Infections RNA Virus Infections Virus Diseases

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