Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response
Latest Information Update: 29 Dec 2022
At a glance
- Drugs Sarilumab (Primary) ; Antivirals; Azithromycin; Hydroxychloroquine; Lopinavir/ritonavir
- Indications COVID 2019 infections; Pneumonia
- Focus Therapeutic Use
- Acronyms COVID-BioB
- 23 Dec 2022 Planned End Date changed from 19 Mar 2023 to 19 Mar 2024.
- 23 Dec 2022 Planned primary completion date changed from 19 Mar 2023 to 19 Mar 2024.
- 21 Dec 2021 Planned number of patients changed from 1000 to 6000.
Most Recent Events
Trial Overview
Purpose
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
Primary Endpoints
Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response
description: 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)
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
| Pneumonia | treatment | severe |
Subjects
- Subject Type patients
-
Number
Planned: 6000
- Sex male & female
- Age Group ≥ 18 years; adult
Patient 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
Patient Exclusion Criteria
- None
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04318366 | ClinicalTrials.gov: US National Institutes of Health |
| COVID-BioB-OSR | - |
Trial Dates
-
Initiation Dates
Actual : 19 Mar 2020
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Primary Completion Dates
Planned : 19 Mar 2024
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End Dates
Planned : 19 Mar 2024
Other Details
- Design cohort; multicentre; observational; open; prospective
- Phase of Trial Phase IV
- Location Italy
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Antivirals |
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|
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| Azithromycin |
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|
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| Hydroxychloroquine | Oral |
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| Lopinavir/ritonavir | Oral |
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| SarilumabPrimary Drug | Intravenous | Infusion |
COVID-19 patients
Other: Observational Study (Not required)
Results
Publications
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Della-Torre E, Campochiaro C, Cavalli G, De Luca G, Napolitano A, La Marca S, et al. Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study. . Ann-Rheum-Dis 2020;.
PubMed | CrossRef Fulltext -
Conte C, Esposito A, De Lorenzo R, Di Filippo L, Palmisano A, Vignale D, et al. 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;31(7):2156-2164.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Adriano Lazzarin, Prof | Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - | Italy |
|
Alberto Zangrillo, Professor
zangrillo.alberto@hsr.it
show details
+390226436151 |
Università Vita-Salute San Raffaele | Italy |
| Andrea Poli, Ing | Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - | Italy |
| Angelo AM Manfredi, Prof | Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute | Italy |
| Antonella Castagna, Prof | Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - | Italy |
| Chiara Bonini, Prof | Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute | Italy |
| Chiara Lanzani, Dr | Nephrology Unit - IRCCS San Raffaele Scientific Institute | Italy |
| Elisa Vicenzi, Dr | Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute | Italy |
| Emanuele Bosi, Prof | Department of Internal Medicine - IRCCS San Raffaele Scientific Institute | Italy |
| Fabio Ciceri, Prof | Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute | Italy |
|
Giovanni Landoni, Professor
+390226436151
show details
landoni.giovanni@hsr.it |
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| Giudo Poli, Prof | AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute | Italy |
| Lorenzo Dagna, Prof | Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute | Italy |
| Lorenzo Piemonti, Prof | Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute | Italy |
| Massimo Clementi, Prof | Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute | Italy |
| Moreno Tresoldi, Dr | Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute | Italy |
| Nicasio Mancini, Prof | Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute | Italy |
| Paolo Manunta, Prof | Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute | Italy |
| Paolo Scarpellini, Dr | Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - | Italy |
| Patrizia Rovere Querini, Prof | Department of Internal Medicine - IRCCS San Raffaele Scientific Institute | Italy |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - |
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| AIDS Immunopathogenesis Unit - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Autoimmunity and Vascular Inflammation Unit, Division of Regenerative Medicine, Stem Cells and Gene Therapy - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Department of Infection Diseases - IRCCS San Raffaele Scientific Institute - | Milan, Lombardy | Italy |
| Department of Internal Medicine - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Diabetes Research Institute -IRCCS San Raffaele Scientific Istitute | Milan, Lombardy | Italy |
| Division of Immunology, Transplantation and Infectious Diseases - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Division of Research of Regenerative Medicine, Cell and Gene Therapy - IRCCS San Raffaele Scientific Istitute | Milan, Lombardy | Italy |
| Laboratory of Microbiology and Virology - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Nephrology Unit - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Strategic Program in Nephrology and Dialysis - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Unit of Immunology, Rheumatology, Allergy and Rare Diseases - IRCCS San Raffaele Scientific Institute | Milan, Lombardy | Italy |
| Università Vita-Salute San Raffaele |
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| Università Vita-Salute San Raffaele | Milano, Mi | Italy |
| Viral pathogens and biosafety Unit - IRCCS San Raffaele Scietific Institute | Milan, Lombardy | Italy |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 29 Dec 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 29 Dec 2022 |
| 23 Dec 2022 | Completion date | Planned End Date changed from 19 Mar 2023 to 19 Mar 2024. Updated 29 Dec 2022 |
| 23 Dec 2022 | Other trial event | Planned primary completion date changed from 19 Mar 2023 to 19 Mar 2024. Updated 29 Dec 2022 |
| 21 Dec 2021 | Other trial event | Planned number of patients changed from 1000 to 6000. Updated 29 Dec 2021 |
| 21 Dec 2021 | Completion date | Planned End Date changed from 19 Mar 2022 to 19 Mar 2023. Updated 29 Dec 2021 |
| 21 Dec 2021 | Other trial event | Planned primary completion date changed from 19 Mar 2022 to 19 Mar 2023. Updated 29 Dec 2021 |
| 30 Jun 2021 | Results | Results (n=192) of post-hoc analysis assessing EAT volume and attenuation (EAT-At, a marker of EAT inflammation) ,Epicardial adipose tissue characteristics, obesity and clinical outcomes in COVID-19 published in the Nutrition, Metabolism and Cardiovascular Diseases Updated 23 Jul 2021 |
| 03 Jul 2020 | Results | Results (n=56) published in the Annals of the Rheumatic Diseases Updated 16 Jul 2020 |
| 09 Apr 2020 | New trial record | New trial record Updated 09 Apr 2020 |
References
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Della-Torre E, Campochiaro C, Cavalli G, De Luca G, Napolitano A, La Marca S, et al. Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study. . Ann-Rheum-Dis 2020;.
PubMed | CrossRef Fulltext -
Conte C, Esposito A, De Lorenzo R, Di Filippo L, Palmisano A, Vignale D, et al. 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;31(7):2156-2164.
PubMed | CrossRef Fulltext
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