Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 4:28 PM
Study NCT ID:
NCT04318366
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2020-03-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response', 'timeFrame': 'Hospital stay (2-3 weeks)', 'description': 'Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infections']}, 'referencesModule': {'references': [{'pmid': '32294809', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '38381905', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38045523', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37053376', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35464004', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35000058', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '34059384', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34002039', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33627313', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33160700', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '32991329', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32945968', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32900326', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32675217', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32501454', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to hospital with biological samples positive for SARS-CoV-2\n* Patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of SARS-CoV-2 disease\n* Patients discharged from emergency department with biological samples positive for SARS-CoV-2\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04318366', 'acronym': 'COVID-BioB', 'briefTitle': 'COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response', 'orgStudyIdInfo': {'id': 'COVID-BioB/OSR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 patients', 'interventionNames': ['Other: Observational Study']}], 'interventions': [{'name': 'Observational Study', 'type': 'OTHER', 'description': 'Not required', 'armGroupLabels': ['COVID-19 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2012', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo AM Manfredi, Prof', 'role': 'CONTACT'}], 'facility': 'Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giudo Poli, Prof', 'role': 'CONTACT'}], 'facility': 'AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Adriano Lazzarin, Prof', 'role': 'CONTACT'}, {'name': 'Antonella Castagna, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paolo Scarpellini, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Poli, Ing', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Infection Diseases - IRCCS San Raffaele Scientific Institute -', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Bosi, Prof', 'role': 'CONTACT'}, {'name': 'Patrizia Rovere Querini, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Internal Medicine - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Piemonti, Prof', 'role': 'CONTACT'}], 'facility': 'Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Bonini, Prof', 'role': 'CONTACT'}], 'facility': 'Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Ciceri, Prof', 'role': 'CONTACT'}], 'facility': 'Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Clementi, Prof', 'role': 'CONTACT'}, {'name': 'Nicasio Mancini, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Lanzani, Dr', 'role': 'CONTACT'}], 'facility': 'Nephrology Unit - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Manunta, Prof', 'role': 'CONTACT'}], 'facility': 'Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Vicenzi, Dr', 'role': 'CONTACT'}], 'facility': 'Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '2132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Dagna, Prof', 'role': 'CONTACT'}, {'name': 'Moreno Tresoldi, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'state': 'Mi', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Landoni, Professor', 'role': 'CONTACT', 'email': 'landoni.giovanni@hsr.it'}, {'name': 'Alberto Zangrillo, Professor', 'role': 'CONTACT', 'email': 'zangrillo.alberto@hsr.it'}], 'facility': 'Università Vita-Salute San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Giovanni Landoni, Professor', 'role': 'CONTACT', 'email': 'landoni.giovanni@hsr.it', 'phone': '+390226436151'}, {'name': 'Alberto Zangrillo, Professor', 'role': 'CONTACT', 'email': 'zangrillo.alberto@hsr.it', 'phone': '+390226436151'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Giovanni Landoni', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}