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Giuseppe Ippolito
Scientific Direction, National Institute for Infectious Diseases “Lazzaro Spallanzani”—IRCCS, 00149 Rome, Italy

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Journal article
Published: 31 August 2021 in Cells
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COVID-19 presents with a wide range of clinical neurological manifestations. It has been recognized that SARS-CoV-2 infection affects both the central and peripheral nervous system, leading to smell and taste disturbances; acute ischemic and hemorrhagic cerebrovascular disease; encephalopathies and seizures; and causes most surviving patients to have long lasting neurological symptoms. Despite this, typical neuropathological features associated with the infection have still not been identified. Studies of post-mortem examinations of the cerebral cortex are obtained with difficulty due to laboratory safety concerns. In addition, they represent cases with different neurological symptoms, age or comorbidities, thus a larger number of brain autoptic data from multiple institutions would be crucial. Histopathological findings described here are aimed to increase the current knowledge on neuropathology of COVID-19 patients. We report post-mortem neuropathological findings of ten COVID-19 patients. A wide range of neuropathological lesions were seen. The cerebral cortex of all patients showed vascular changes, hyperemia of the meninges and perivascular inflammation in the cerebral parenchyma with hypoxic neuronal injury. Perivascular lymphocytic inflammation of predominantly CD8-positive T cells mixed with CD68-positive macrophages, targeting the disrupted vascular wall in the cerebral cortex, cerebellum and pons were seen. Our findings support recent reports highlighting a role of microvascular injury in COVID-19 neurological manifestations.

ACS Style

Daniele Colombo; Laura Falasca; Luisa Marchioni; Antonella Tammaro; Ganiyat Adenike Ralitsa Adebanjo; Giuseppe Ippolito; Alimuddin Zumla; Mauro Piacentini; Roberta Nardacci; Franca Del Nonno. Neuropathology and Inflammatory Cell Characterization in 10 Autoptic COVID-19 Brains. Cells 2021, 10, 2262 .

AMA Style

Daniele Colombo, Laura Falasca, Luisa Marchioni, Antonella Tammaro, Ganiyat Adenike Ralitsa Adebanjo, Giuseppe Ippolito, Alimuddin Zumla, Mauro Piacentini, Roberta Nardacci, Franca Del Nonno. Neuropathology and Inflammatory Cell Characterization in 10 Autoptic COVID-19 Brains. Cells. 2021; 10 (9):2262.

Chicago/Turabian Style

Daniele Colombo; Laura Falasca; Luisa Marchioni; Antonella Tammaro; Ganiyat Adenike Ralitsa Adebanjo; Giuseppe Ippolito; Alimuddin Zumla; Mauro Piacentini; Roberta Nardacci; Franca Del Nonno. 2021. "Neuropathology and Inflammatory Cell Characterization in 10 Autoptic COVID-19 Brains." Cells 10, no. 9: 2262.

Brief report
Published: 17 August 2021 in Cells
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Massive platelet activation and thrombotic events characterize severe COVID-19, highlighting their critical role in SARS-CoV-2-induced immunopathology. Since there is a well-described expansion of myeloid-derived suppressor cells (MDSC) in severe COVID-19, we evaluated their possible role in platelet activation during SARS-CoV-2 infection. During COVID-19, a lower plasmatic L-arginine level was observed compared to healthy donors, which correlated with MDSC frequency. Additionally, activated GPIIb/IIIa complex (PAC-1) expression was higher on platelets from severe COVID-19 patients compared to healthy controls and inversely correlated with L-arginine plasmatic concentration. Notably, MDSC were able to induce PAC-1 expression in vitro by reducing L-arginine concentration, indicating a direct role of PMN-MDSC in platelet activation. Accordingly, we found a positive correlation between ex vivo platelet PAC-1 expression and PMN-MDSC frequency. Overall, our data demonstrate the involvement of PMN-MDSC in triggering platelet activation during COVID-19, highlighting a novel role of MDSC in driving COVID-19 pathogenesis.

ACS Style

Alessandra Sacchi; Germana Grassi; Stefania Notari; Simona Gili; Veronica Bordoni; Eleonora Tartaglia; Rita Casetti; Eleonora Cimini; Davide Mariotti; Gabriele Garotto; Alessia Beccacece; Luisa Marchioni; Michele Bibas; Emanuele Nicastri; Giuseppe Ippolito; Chiara Agrati. Expansion of Myeloid Derived Suppressor Cells Contributes to Platelet Activation by L-Arginine Deprivation during SARS-CoV-2 Infection. Cells 2021, 10, 2111 .

AMA Style

Alessandra Sacchi, Germana Grassi, Stefania Notari, Simona Gili, Veronica Bordoni, Eleonora Tartaglia, Rita Casetti, Eleonora Cimini, Davide Mariotti, Gabriele Garotto, Alessia Beccacece, Luisa Marchioni, Michele Bibas, Emanuele Nicastri, Giuseppe Ippolito, Chiara Agrati. Expansion of Myeloid Derived Suppressor Cells Contributes to Platelet Activation by L-Arginine Deprivation during SARS-CoV-2 Infection. Cells. 2021; 10 (8):2111.

Chicago/Turabian Style

Alessandra Sacchi; Germana Grassi; Stefania Notari; Simona Gili; Veronica Bordoni; Eleonora Tartaglia; Rita Casetti; Eleonora Cimini; Davide Mariotti; Gabriele Garotto; Alessia Beccacece; Luisa Marchioni; Michele Bibas; Emanuele Nicastri; Giuseppe Ippolito; Chiara Agrati. 2021. "Expansion of Myeloid Derived Suppressor Cells Contributes to Platelet Activation by L-Arginine Deprivation during SARS-CoV-2 Infection." Cells 10, no. 8: 2111.

Journal article
Published: 12 August 2021 in Cell Death & Disease
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In the last months, many studies have clearly described several mechanisms of SARS-CoV-2 infection at cell and tissue level, but the mechanisms of interaction between host and SARS-CoV-2, determining the grade of COVID-19 severity, are still unknown. We provide a network analysis on protein–protein interactions (PPI) between viral and host proteins to better identify host biological responses, induced by both whole proteome of SARS-CoV-2 and specific viral proteins. A host-virus interactome was inferred, applying an explorative algorithm (Random Walk with Restart, RWR) triggered by 28 proteins of SARS-CoV-2. The analysis of PPI allowed to estimate the distribution of SARS-CoV-2 proteins in the host cell. Interactome built around one single viral protein allowed to define a different response, underlining as ORF8 and ORF3a modulated cardiovascular diseases and pro-inflammatory pathways, respectively. Finally, the network-based approach highlighted a possible direct action of ORF3a and NS7b to enhancing Bradykinin Storm. This network-based representation of SARS-CoV-2 infection could be a framework for pathogenic evaluation of specific clinical outcomes. We identified possible host responses induced by specific proteins of SARS-CoV-2, underlining the important role of specific viral accessory proteins in pathogenic phenotypes of severe COVID-19 patients.

ACS Style

Francesco Messina; Emanuela Giombini; Chiara Montaldo; Ashish Arunkumar Sharma; Antonio Zoccoli; Rafick-Pierre Sekaly; Franco Locatelli; Alimuddin Zumla; Markus Maeurer; Maria R. Capobianchi; Francesco Nicola Lauria; Giuseppe Ippolito. Looking for pathways related to COVID-19: confirmation of pathogenic mechanisms by SARS-CoV-2–host interactome. Cell Death & Disease 2021, 12, 1 .

AMA Style

Francesco Messina, Emanuela Giombini, Chiara Montaldo, Ashish Arunkumar Sharma, Antonio Zoccoli, Rafick-Pierre Sekaly, Franco Locatelli, Alimuddin Zumla, Markus Maeurer, Maria R. Capobianchi, Francesco Nicola Lauria, Giuseppe Ippolito. Looking for pathways related to COVID-19: confirmation of pathogenic mechanisms by SARS-CoV-2–host interactome. Cell Death & Disease. 2021; 12 (8):1.

Chicago/Turabian Style

Francesco Messina; Emanuela Giombini; Chiara Montaldo; Ashish Arunkumar Sharma; Antonio Zoccoli; Rafick-Pierre Sekaly; Franco Locatelli; Alimuddin Zumla; Markus Maeurer; Maria R. Capobianchi; Francesco Nicola Lauria; Giuseppe Ippolito. 2021. "Looking for pathways related to COVID-19: confirmation of pathogenic mechanisms by SARS-CoV-2–host interactome." Cell Death & Disease 12, no. 8: 1.

Article
Published: 04 August 2021
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Summary Background The emerging threat represented by SARS-CoV-2 variants, demands the development of therapies for better clinical management of COVID-19. MAD0004J08 is an extremely potent Fc-engineered monoclonal antibody (mAb) able to neutralise in vitro all current SARS-CoV-2 variants of concern (VoCs). This ongoing study, evaluates safety, pharmacokinetics and SARS-CoV-2 sera neutralization effect of MAD0004J08 when administered as single dose intramuscularly in healthy adults. Method We conducted a dose escalation study with sequential enrolment of three cohorts, each with an increasing dose level of MAD0004J08 (48mg, 100mg and 400mg). Within each cohort, 10 young healthy adults were randomized with 4:1 ratio to a single intramuscular (i.m.) injection of MAD0004J08 or placebo. The primary endpoint is the proportion of subjects with severe and/or serious treatment emergent adverse events (TEAEs) within 7 days post-treatment. Secondary endpoints reported in this paper are the proportion of subjects with solicited TEAEs up 7 days post dosing, MAD0004J08 serum concentrations and neutralising activity versus the original SARS-COV-2 Wuhan virus at different timepoints post-dosing. As post-hoc analyses, we compared the sera neutralising titres of subjects who received MAD0004J08 with those of people that had received the COVID-19 BNT162b2 mRNA vaccine in the previous sixty days (n=10) and COVID-19 convalescent patients (n=20), and assessed serum neutralisation activity against the B.1.1.7 (alpha), B.1.351 (beta) and B.1.1.248 (gamma) SARS-CoV-2 variants of concern. Findings A total of 30 subjects, 10 per cohort, were enrolled and randomized. Data up to 30 days were available and analysed in this report. No severe TEAEs were reported in any of the cohorts in the 7 days post-treatment. MAD0004J08 was detected in the sera of treated subjects within few hours post-administration and reached almost maximal levels on day 8. The geometric mean neutralising titres (GMT) assessed against the original Wuhan virus peaked on day 8 and ranged 226 – 905, 905 – 2,560, and 1,280 – 5,120 for cohort 1, 2 and 3 respectively. The sera neutralising GMT in MAD0004J08 treated subjects in all the three cohorts were found to be 1·5-54·5-fold higher compared to sera from convalescent patients and 1·83– 76·4-fold higher compared to sera from COVID-19 vaccinees. Finally, GMT in MAD0004J08 treated subjects showed high neutralising titres versus the B.1.1.7 (alpha), B.1.351 (beta) and B.1.1.248 (gamma) SARS-CoV-2 VoCs. Interpretation A single dose administration of MAD0004J08 via i.m. route is safe and well tolerated and results in a rapid systemic distribution of the MAD0004J08 and sera neutralising titres higher than COVID-19 convalescent and vaccinated subjects. A single dose administration of MAD0004J08 is also sufficient to effectively neutralise major SARS-CoV-2 variants of concern. Based on these results, a Phase 2-3 trial is ongoing to further assess the safety, dosage, and efficacy of MAD0004J08 in asymptomatic or mild-moderate symptomatic COVID-19 patients. Funding EU Malaria Fund, Ministero dello Sviluppo Economico, Ministero della Salute, Regione Toscana, Toscana Life Sciences Sviluppo and European Research Council. Research in context Evidence before this study We searched PUBMED, MEDLINE and MedRxiv for clinical trials, meta-analyses and randomized controlled trials evaluating the antibody neutralization titres vs. different SARS-CoV-2 variants of concern obtained from subjects who received monoclonal antibodies for the treatment of COVID-19 using the following search terms: (“COVID-19” OR “SARS-CoV-2”) AND (“monoclonal antibody” OR “neutralising antibody”) AND (“variants” OR “variants of concern”). No relevant studies were identified. Added value of this study This is the first human study assessing safety, PK and neutralising potential of MAD0004J08, a monoclonal antibody against SARS-CoV-2 wild type Wuhan virus and variants of concern, administered intramuscularly at low dosages (48, 100 and 400 mg). MAD0004J08 showed to be safe and well tolerated in the tested dose range. Anti-spike antibodies were detected in the sera of tested SARS-CoV-2 negative healthy adults few hours post-injection. In addition, the sera obtained from MAD0004J08treated subjects, showed to have high neutralisation titres against the Wuhan virus, the B.1.1.7 (alpha), B.1.351 (beta) and B.1.1.248 (gamma) variants of concern. Implications of all the available evidence A potent monoclonal antibody such as MAD0004J08, capable of neutralising multiple variants of concern of SARS-CoV-2 rapidly and long lastingly when given as a single intramuscular injection. The antibody, presently tested in a phase 2-3 efficacy trial, can be a major advancement in the prophylaxis and clinical management of COVID-19, because of its broad spectrum, ease of use in non-hospital settings and economic sustainability.

ACS Style

Simone Lanini; Stefano Milleri; Emanuele Andreano; Sarah Nosari; Ida Paciello; Giulia Piccini; Alessandra Gentili; Adhuna Phogat; Inesa Hyseni; Margherita Leonardi; Alessandro Torelli; Emanuele Montomoli; Andrea Paolini; Andrea Frosini; Andrea Antinori; Emanuele Nicastri; Enrico Girardi; Maria Maddalena Plazzi; Giuseppe Ippolito; Francesco Vaia; Giovanni Della Cioppa; Rino Rappuoli. A single intramuscular injection of monoclonal antibody MAD0004J08 induces in healthy adults SARS-CoV-2 neutralising antibody titres exceeding those induced by infection and vaccination. 2021, 1 .

AMA Style

Simone Lanini, Stefano Milleri, Emanuele Andreano, Sarah Nosari, Ida Paciello, Giulia Piccini, Alessandra Gentili, Adhuna Phogat, Inesa Hyseni, Margherita Leonardi, Alessandro Torelli, Emanuele Montomoli, Andrea Paolini, Andrea Frosini, Andrea Antinori, Emanuele Nicastri, Enrico Girardi, Maria Maddalena Plazzi, Giuseppe Ippolito, Francesco Vaia, Giovanni Della Cioppa, Rino Rappuoli. A single intramuscular injection of monoclonal antibody MAD0004J08 induces in healthy adults SARS-CoV-2 neutralising antibody titres exceeding those induced by infection and vaccination. . 2021; ():1.

Chicago/Turabian Style

Simone Lanini; Stefano Milleri; Emanuele Andreano; Sarah Nosari; Ida Paciello; Giulia Piccini; Alessandra Gentili; Adhuna Phogat; Inesa Hyseni; Margherita Leonardi; Alessandro Torelli; Emanuele Montomoli; Andrea Paolini; Andrea Frosini; Andrea Antinori; Emanuele Nicastri; Enrico Girardi; Maria Maddalena Plazzi; Giuseppe Ippolito; Francesco Vaia; Giovanni Della Cioppa; Rino Rappuoli. 2021. "A single intramuscular injection of monoclonal antibody MAD0004J08 induces in healthy adults SARS-CoV-2 neutralising antibody titres exceeding those induced by infection and vaccination." , no. : 1.

Journal article
Published: 28 July 2021 in Journal of Clinical Medicine
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Background: The benefits and timing of percutaneous dilatational tracheostomy (PDT) in Intensive Care Unit (ICU) COVID-19 patients are still controversial. PDT is considered a high-risk procedure for the transmission of SARS-CoV-2 to healthcare workers (HCWs). The present study analyzed the optimal timing of PDT, the clinical outcomes of patients undergoing PDT, and the safety of HCWs performing PDT. Methods: Of the 133 COVID-19 patients who underwent PDT in our ICU from 1 April 2020 to 31 March 2021, 13 patients were excluded, and 120 patients were enrolled. A trained medical team was dedicated to the PDT procedure. Demographic, clinical history, and outcome data were collected. Patients who underwent PDT were stratified into two groups: an early group (PDT ≤ 12 days after orotracheal intubation (OTI) and a late group (>12 days after OTI). An HCW surveillance program was also performed. Results: The early group included 61 patients and the late group included 59 patients. The early group patients had a shorter ICU length of stay and fewer days of mechanical ventilation than the late group (p< 0.001). On day 7 after tracheostomy, early group patients required fewer intravenous anesthetic drugs and experienced an improvement of the ventilation parameters PaO2/FiO2 ratio, PEEP, and FiO2 (p< 0.001). No difference in the case fatality ratio between the two groups was observed. No SARS-CoV-2 infections were reported in the HCWs performing the PDTs. Conclusions: PDT was safe and effective for COVID-19 patients since it improved respiratory support parameters, reduced ICU length of stay and duration of mechanical ventilation, and optimized the weaning process. The procedure was safe for all HCWs involved in the dedicated medical team. The development of standardized early PDT protocols should be implemented, and PDT could be considered a first-line approach in ICU COVID-19 patients requiring prolonged mechanical ventilation.

ACS Style

Nardi Tetaj; Micaela Maritti; Giulia Stazi; Maria Marini; Daniele Centanni; Gabriele Garotto; Ilaria Caravella; Cristina Dantimi; Matteo Fusetti; Carmen Santagata; Manuela Macchione; Giada De Angelis; Filippo Giansante; Donatella Busso; Rachele Di Lorenzo; Silvana Scarcia; Alessandro Carucci; Ricardo Cabas; Ilaria Gaviano; Nicola Petrosillo; Andrea Antinori; Fabrizio Palmieri; Gianpiero D’Offizi; Stefania Ianniello; Paolo Campioni; Francesco Pugliese; Francesco Vaia; Emanuele Nicastri; Giuseppe Ippolito; Luisa Marchioni; ICU COVID-19 Study Group. Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients over a Year in the Intensive Care Unit. Journal of Clinical Medicine 2021, 10, 3335 .

AMA Style

Nardi Tetaj, Micaela Maritti, Giulia Stazi, Maria Marini, Daniele Centanni, Gabriele Garotto, Ilaria Caravella, Cristina Dantimi, Matteo Fusetti, Carmen Santagata, Manuela Macchione, Giada De Angelis, Filippo Giansante, Donatella Busso, Rachele Di Lorenzo, Silvana Scarcia, Alessandro Carucci, Ricardo Cabas, Ilaria Gaviano, Nicola Petrosillo, Andrea Antinori, Fabrizio Palmieri, Gianpiero D’Offizi, Stefania Ianniello, Paolo Campioni, Francesco Pugliese, Francesco Vaia, Emanuele Nicastri, Giuseppe Ippolito, Luisa Marchioni, ICU COVID-19 Study Group. Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients over a Year in the Intensive Care Unit. Journal of Clinical Medicine. 2021; 10 (15):3335.

Chicago/Turabian Style

Nardi Tetaj; Micaela Maritti; Giulia Stazi; Maria Marini; Daniele Centanni; Gabriele Garotto; Ilaria Caravella; Cristina Dantimi; Matteo Fusetti; Carmen Santagata; Manuela Macchione; Giada De Angelis; Filippo Giansante; Donatella Busso; Rachele Di Lorenzo; Silvana Scarcia; Alessandro Carucci; Ricardo Cabas; Ilaria Gaviano; Nicola Petrosillo; Andrea Antinori; Fabrizio Palmieri; Gianpiero D’Offizi; Stefania Ianniello; Paolo Campioni; Francesco Pugliese; Francesco Vaia; Emanuele Nicastri; Giuseppe Ippolito; Luisa Marchioni; ICU COVID-19 Study Group. 2021. "Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients over a Year in the Intensive Care Unit." Journal of Clinical Medicine 10, no. 15: 3335.

Journal article
Published: 22 July 2021 in Journal of Clinical Medicine
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Introduction: The use of steroid therapy in patients within the context of SARS-CoV-2 infection is still a matter of debate. This study aimed to evaluate if potential steroid benefits could be predicted by the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) (P/F) in COVID-19 patients at admission. Materials and Methods: Medical records were retrospectively collected from all adult patients admitted because of COVID-19 from 29 January to 31 July 2020. The association of steroid therapy with 28-day all-cause mortality outcome was analysed in a multivariable logistic regression model adjusted for confounding factors. Results: Overall, 511 patients were analysed, of which 39.1% underwent steroid therapy. Steroid treated patients were mostly male, older, and more frequently treated with antiviral drugs and aminoquinolines; the most common comorbidities were hypertension, followed by cardiovascular disease. Overall, 51 patients died within 28-days, and overall 28-days mortality was 19.5% in the cohort of patients exposed to steroids versus 3.9% mortality in unexposed patients (p< 0.001). Steroid therapy on patients with P/F ratio of 235 mmHg or higher at admission can be considered as detrimental, with an 8% increased probability of death. Conclusions: Steroid therapy is associated with increased 28-day mortality in COVID-19 in patients with mild or no ARDS.

ACS Style

Serena Vita; Daniele Centanni; Simone Lanini; Pierluca Piselli; Silvia Rosati; Maria Giancola; Annalisa Mondi; Carmela Pinnetti; Simone Topino; Pierangelo Chinello; Silvia Mosti; Gina Gualano; Francesca Faraglia; Fabio Iacomi; Luisa Marchioni; Micaela Maritti; Enrico Girardi; Giuseppe Ippolito; Emanuele Nicastri; on behalf of the ReCOVeRI Study Group. Benefits of Steroid Therapy in COVID-19 Patients with Different PaO2/FiO2 Ratio at Admission. Journal of Clinical Medicine 2021, 10, 3236 .

AMA Style

Serena Vita, Daniele Centanni, Simone Lanini, Pierluca Piselli, Silvia Rosati, Maria Giancola, Annalisa Mondi, Carmela Pinnetti, Simone Topino, Pierangelo Chinello, Silvia Mosti, Gina Gualano, Francesca Faraglia, Fabio Iacomi, Luisa Marchioni, Micaela Maritti, Enrico Girardi, Giuseppe Ippolito, Emanuele Nicastri, on behalf of the ReCOVeRI Study Group. Benefits of Steroid Therapy in COVID-19 Patients with Different PaO2/FiO2 Ratio at Admission. Journal of Clinical Medicine. 2021; 10 (15):3236.

Chicago/Turabian Style

Serena Vita; Daniele Centanni; Simone Lanini; Pierluca Piselli; Silvia Rosati; Maria Giancola; Annalisa Mondi; Carmela Pinnetti; Simone Topino; Pierangelo Chinello; Silvia Mosti; Gina Gualano; Francesca Faraglia; Fabio Iacomi; Luisa Marchioni; Micaela Maritti; Enrico Girardi; Giuseppe Ippolito; Emanuele Nicastri; on behalf of the ReCOVeRI Study Group. 2021. "Benefits of Steroid Therapy in COVID-19 Patients with Different PaO2/FiO2 Ratio at Admission." Journal of Clinical Medicine 10, no. 15: 3236.

Journal article
Published: 06 July 2021 in Viruses
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Complex systems are inherently multilevel and multiscale systems. The infectious disease system is considered a complex system resulting from the interaction between three sub-systems (host, pathogen, and environment) organized into a hierarchical structure, ranging from the cellular to the macro-ecosystem level, with multiscales. Therefore, to describe infectious disease phenomena that change through time and space and at different scales, we built a model framework where infectious disease must be considered the set of biological responses of human hosts to pathogens, with biological pathways shared with other pathologies in an ecological interaction context. In this paper, we aimed to design a framework for building a disease model for COVID-19 based on current literature evidence. The model was set up by identifying the molecular pathophysiology related to the COVID-19 phenotypes, collecting the mechanistic knowledge scattered across scientific literature and bioinformatic databases, and integrating it using a logical/conceptual model systems biology. The model framework building process began from the results of a domain-based literature review regarding a multiomics approach to COVID-19. This evidence allowed us to define a framework of COVID-19 conceptual model and to report all concepts in a multilevel and multiscale structure. The same interdisciplinary working groups that carried out the scoping review were involved. The conclusive result is a conceptual method to design multiscale models of infectious diseases. The methodology, applied in this paper, is a set of partially ordered research and development activities that result in a COVID-19 multiscale model.

ACS Style

Francesco Messina; Chiara Montaldo; Isabella Abbate; Manuela Antonioli; Veronica Bordoni; Giulia Matusali; Alessandra Sacchi; Emanuela Giombini; Gian Fimia; Mauro Piacentini; Maria Capobianchi; Francesco Lauria; Giuseppe Ippolito; on behalf of COVID-19 Scoping Review Working Group. Rationale and Criteria for a COVID-19 Model Framework. Viruses 2021, 13, 1309 .

AMA Style

Francesco Messina, Chiara Montaldo, Isabella Abbate, Manuela Antonioli, Veronica Bordoni, Giulia Matusali, Alessandra Sacchi, Emanuela Giombini, Gian Fimia, Mauro Piacentini, Maria Capobianchi, Francesco Lauria, Giuseppe Ippolito, on behalf of COVID-19 Scoping Review Working Group. Rationale and Criteria for a COVID-19 Model Framework. Viruses. 2021; 13 (7):1309.

Chicago/Turabian Style

Francesco Messina; Chiara Montaldo; Isabella Abbate; Manuela Antonioli; Veronica Bordoni; Giulia Matusali; Alessandra Sacchi; Emanuela Giombini; Gian Fimia; Mauro Piacentini; Maria Capobianchi; Francesco Lauria; Giuseppe Ippolito; on behalf of COVID-19 Scoping Review Working Group. 2021. "Rationale and Criteria for a COVID-19 Model Framework." Viruses 13, no. 7: 1309.

Article
Published: 06 July 2021 in Cell Death & Differentiation
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Patients with cancer are at higher risk of severe coronavirus infectious disease 2019 (COVID-19), but the mechanisms underlying virus–host interactions during cancer therapies remain elusive. When comparing nasopharyngeal swabs from cancer and noncancer patients for RT-qPCR cycle thresholds measuring acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in 1063 patients (58% with cancer), we found that malignant disease favors the magnitude and duration of viral RNA shedding concomitant with prolonged serum elevations of type 1 IFN that anticorrelated with anti-RBD IgG antibodies. Cancer patients with a prolonged SARS-CoV-2 RNA detection exhibited the typical immunopathology of severe COVID-19 at the early phase of infection including circulation of immature neutrophils, depletion of nonconventional monocytes, and a general lymphopenia that, however, was accompanied by a rise in plasmablasts, activated follicular T-helper cells, and non-naive Granzyme B+FasL+, EomeshighTCF-1high, PD-1+CD8+ Tc1 cells. Virus-induced lymphopenia worsened cancer-associated lymphocyte loss, and low lymphocyte counts correlated with chronic SARS-CoV-2 RNA shedding, COVID-19 severity, and a higher risk of cancer-related death in the first and second surge of the pandemic. Lymphocyte loss correlated with significant changes in metabolites from the polyamine and biliary salt pathways as well as increased blood DNA from Enterobacteriaceae and Micrococcaceae gut family members in long-term viral carriers. We surmise that cancer therapies may exacerbate the paradoxical association between lymphopenia and COVID-19-related immunopathology, and that the prevention of COVID-19-induced lymphocyte loss may reduce cancer-associated death.

ACS Style

Anne-Gaëlle Goubet; Agathe Dubuisson; Arthur Geraud; François-Xavier Danlos; Safae Terrisse; Carolina Alves Costa Silva; Damien Drubay; Lea Touri; Marion Picard; Marine Mazzenga; Aymeric Silvin; Garett Dunsmore; Yacine Haddad; Eugenie Pizzato; Pierre Ly; Caroline Flament; Cléa Melenotte; Eric Solary; Michaela Fontenay; Gabriel Garcia; Corinne Balleyguier; Nathalie Lassau; Markus Maeurer; Claudia Grajeda-Iglesias; Nitharsshini Nirmalathasan; Fanny Aprahamian; Sylvère Durand; Oliver Kepp; Gladys Ferrere; Cassandra Thelemaque; Imran Lahmar; Jean-Eudes Fahrner; Lydia Meziani; Abdelhakim Ahmed-Belkacem; Nadia Saïdani; Bernard La Scola; Didier Raoult; Stéphanie Gentile; Sébastien Cortaredona; Giuseppe Ippolito; Benjamin Lelouvier; Alain Roulet; Fabrice Andre; Fabrice Barlesi; Jean-Charles Soria; Caroline Pradon; Emmanuelle Gallois; Fanny Pommeret; Emeline Colomba; Florent Ginhoux; Suzanne Kazandjian; Arielle Elkrief; Bertrand Routy; Makoto Miyara; Guy Gorochov; Eric Deutsch; Laurence Albiges; Annabelle Stoclin; Bertrand Gachot; Anne Florin; Mansouria Merad; Florian Scotte; Souad Assaad; Guido Kroemer; Jean-Yves Blay; Aurélien Marabelle; Frank Griscelli; Laurence Zitvogel; Lisa Derosa. Prolonged SARS-CoV-2 RNA virus shedding and lymphopenia are hallmarks of COVID-19 in cancer patients with poor prognosis. Cell Death & Differentiation 2021, 1 -19.

AMA Style

Anne-Gaëlle Goubet, Agathe Dubuisson, Arthur Geraud, François-Xavier Danlos, Safae Terrisse, Carolina Alves Costa Silva, Damien Drubay, Lea Touri, Marion Picard, Marine Mazzenga, Aymeric Silvin, Garett Dunsmore, Yacine Haddad, Eugenie Pizzato, Pierre Ly, Caroline Flament, Cléa Melenotte, Eric Solary, Michaela Fontenay, Gabriel Garcia, Corinne Balleyguier, Nathalie Lassau, Markus Maeurer, Claudia Grajeda-Iglesias, Nitharsshini Nirmalathasan, Fanny Aprahamian, Sylvère Durand, Oliver Kepp, Gladys Ferrere, Cassandra Thelemaque, Imran Lahmar, Jean-Eudes Fahrner, Lydia Meziani, Abdelhakim Ahmed-Belkacem, Nadia Saïdani, Bernard La Scola, Didier Raoult, Stéphanie Gentile, Sébastien Cortaredona, Giuseppe Ippolito, Benjamin Lelouvier, Alain Roulet, Fabrice Andre, Fabrice Barlesi, Jean-Charles Soria, Caroline Pradon, Emmanuelle Gallois, Fanny Pommeret, Emeline Colomba, Florent Ginhoux, Suzanne Kazandjian, Arielle Elkrief, Bertrand Routy, Makoto Miyara, Guy Gorochov, Eric Deutsch, Laurence Albiges, Annabelle Stoclin, Bertrand Gachot, Anne Florin, Mansouria Merad, Florian Scotte, Souad Assaad, Guido Kroemer, Jean-Yves Blay, Aurélien Marabelle, Frank Griscelli, Laurence Zitvogel, Lisa Derosa. Prolonged SARS-CoV-2 RNA virus shedding and lymphopenia are hallmarks of COVID-19 in cancer patients with poor prognosis. Cell Death & Differentiation. 2021; ():1-19.

Chicago/Turabian Style

Anne-Gaëlle Goubet; Agathe Dubuisson; Arthur Geraud; François-Xavier Danlos; Safae Terrisse; Carolina Alves Costa Silva; Damien Drubay; Lea Touri; Marion Picard; Marine Mazzenga; Aymeric Silvin; Garett Dunsmore; Yacine Haddad; Eugenie Pizzato; Pierre Ly; Caroline Flament; Cléa Melenotte; Eric Solary; Michaela Fontenay; Gabriel Garcia; Corinne Balleyguier; Nathalie Lassau; Markus Maeurer; Claudia Grajeda-Iglesias; Nitharsshini Nirmalathasan; Fanny Aprahamian; Sylvère Durand; Oliver Kepp; Gladys Ferrere; Cassandra Thelemaque; Imran Lahmar; Jean-Eudes Fahrner; Lydia Meziani; Abdelhakim Ahmed-Belkacem; Nadia Saïdani; Bernard La Scola; Didier Raoult; Stéphanie Gentile; Sébastien Cortaredona; Giuseppe Ippolito; Benjamin Lelouvier; Alain Roulet; Fabrice Andre; Fabrice Barlesi; Jean-Charles Soria; Caroline Pradon; Emmanuelle Gallois; Fanny Pommeret; Emeline Colomba; Florent Ginhoux; Suzanne Kazandjian; Arielle Elkrief; Bertrand Routy; Makoto Miyara; Guy Gorochov; Eric Deutsch; Laurence Albiges; Annabelle Stoclin; Bertrand Gachot; Anne Florin; Mansouria Merad; Florian Scotte; Souad Assaad; Guido Kroemer; Jean-Yves Blay; Aurélien Marabelle; Frank Griscelli; Laurence Zitvogel; Lisa Derosa. 2021. "Prolonged SARS-CoV-2 RNA virus shedding and lymphopenia are hallmarks of COVID-19 in cancer patients with poor prognosis." Cell Death & Differentiation , no. : 1-19.

Preprint
Published: 01 July 2021
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(1) Background: Benefits and timing of percutaneous dilatational tracheostomy (PDT) in Intensive Care Unit (ICU) COVID-19 patients are still controversial. PDT is considered a high risk procedure for transmission of SARS CoV-2 to health care workers (HCWs). The present study analyzed optimal timing of PDT, clinical outcomes of patients undergoing PDT and safety of HCWs performing PDT. (2) Methods: 133 COVID-19 patients underwent PDT in our ICU from April 1, 2020 to March 31, 2021, 23 patients were excluded and 110 patients were enrolled. A trained medical team was dedicated to the PDT procedure. Demographic, clinical history and outcome data were collected. Patients who underwent PDT were stratified into two groups: early group, PDT ≤ 12 days from orotracheal-intubation (OTI) and late group, >12 days from OTI; HCW surveillance program was performed. (3) Results: Early group included 57 patients and late group included 53 patients. Early group patients showed shorter ICU length of stay and fewer days of mechanical ventilation than the late group (p<0.001). At day 7 after tracheostomy, early group patients required fewer intravenous anesthetic drugs and experienced an improvement of ventilation parameters, PaO2/FiO2-Ratio, PEEP and FiO2 (p<0.001). No difference in case fatality ratio between the two groups was reported. No SARS-CoV-2 infection was reported in HCWs performing PDT. (4) Conclusions: PDT was safe and effective for COVID-19 patients, since it improved respiratory support parameters, reduced ICU length of stay and duration of mechanical ventilation, and optimized the weaning process. The procedure was safe for all HCWs involved in the dedicated medical team. The development of standardized early PDT protocols should be implemented and PDT procedure could be considered as first line approach in ICU COVID-19 requiring prolonged mechanical ventilation.

ACS Style

Nardi Tetaj; Micaela Maritti; Giulia Stazi; Maria Cristina Marini; Daniele Centanni; Gabriele Garotto; Ilaria Caravella; Cristina Dantimi; Matteo Fusetti; Carmen Santagata; Manuela Macchione; Giada De Angelis; Filippo Giansante; Donatella Busso; Rachele Di Lorenzo; Silvana Scarcia; Alessandro Carucci; Ricardo Cabas; Ilaria Gaviano; Nicola Petrosillo; Andrea Antinori; Fabrizio Palmieri; Gianpiero D'Offizi; Stefania Ianniello; Paolo Campioni; Francesco Pugliese; Francesco Vaia; Emanuele Nicastri; Giuseppe Ippolito; Luisa Marchioni. Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients Over a Year in Intensive Care Unit. 2021, 1 .

AMA Style

Nardi Tetaj, Micaela Maritti, Giulia Stazi, Maria Cristina Marini, Daniele Centanni, Gabriele Garotto, Ilaria Caravella, Cristina Dantimi, Matteo Fusetti, Carmen Santagata, Manuela Macchione, Giada De Angelis, Filippo Giansante, Donatella Busso, Rachele Di Lorenzo, Silvana Scarcia, Alessandro Carucci, Ricardo Cabas, Ilaria Gaviano, Nicola Petrosillo, Andrea Antinori, Fabrizio Palmieri, Gianpiero D'Offizi, Stefania Ianniello, Paolo Campioni, Francesco Pugliese, Francesco Vaia, Emanuele Nicastri, Giuseppe Ippolito, Luisa Marchioni. Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients Over a Year in Intensive Care Unit. . 2021; ():1.

Chicago/Turabian Style

Nardi Tetaj; Micaela Maritti; Giulia Stazi; Maria Cristina Marini; Daniele Centanni; Gabriele Garotto; Ilaria Caravella; Cristina Dantimi; Matteo Fusetti; Carmen Santagata; Manuela Macchione; Giada De Angelis; Filippo Giansante; Donatella Busso; Rachele Di Lorenzo; Silvana Scarcia; Alessandro Carucci; Ricardo Cabas; Ilaria Gaviano; Nicola Petrosillo; Andrea Antinori; Fabrizio Palmieri; Gianpiero D'Offizi; Stefania Ianniello; Paolo Campioni; Francesco Pugliese; Francesco Vaia; Emanuele Nicastri; Giuseppe Ippolito; Luisa Marchioni. 2021. "Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients Over a Year in Intensive Care Unit." , no. : 1.

Preprint content
Published: 25 June 2021
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Early recognition of risk and start of treatment may improve unfavorable outcome of COVID-19. In the SAVE-MORE double-blind randomized trial, 594 patients with pneumonia without respiratory dysfunction at risk as defined by plasma suPAR (soluble urokinase plasminogen activator receptor) ≥ 6 ng/ml were 1:2 randomized to subcutaneous placebo or 100 mg anakinra once daily for 10 days; 85.9% were co-administered dexamethasone. After 28 days, anakinra-treated patients were distributed to lower strata of the 11-point World Health Organization ordinal Clinical Progression Scale (WHO-CPS) (adjusted odds ratio-OR 0.36; 95%CI 0.26–0.50; P < 0.001); anakinra protected from severe disease or death (≥ 6 points of WHO-CPS) (OR: 0.46; P: 0.010). The median WHO-CPS decrease in the placebo and anakinra groups was 3 and 4 points (OR 0.40; P < 0.0001); the median decrease of SOFA score was 0 and 1 points (OR 0.63; P: 0.004). 28-day mortality decreased (hazard ratio: 0.45; P: 0.045) and hospital stay was shorter. (Sponsored by the Hellenic Institute for the Study of Sepsis ClinicalTrials.gov identifier, NCT04680949)

ACS Style

Evangelos Giamarellos-Bourboulis; Evdoxia Kyriazopoulou; Garyfallia Poulakou; Haralampos Milionis; Simeon Metallidis; Georgios Adamis; Konstantinos Tsiakos; Archontoula Fragkou; Aggeliki Rapti; Christina Damoulari; Massimo Fantoni; Ioannis Kalomenidis; Georgios Chrysos; Andrea Angeheben; Ilias Kainis; Zoi Alexiou; Francesco Castelli; Francesco Saverio Serino; Maria Tsilika; Petros Bakakos; Emanuele Nicastri; Vassiliki Tzavara; Evangelos Kostis; Lorenzo Dagna; Panayiotis Koufargyris; Katerina Dimakou; Spyridon Savvanis; Glykeria Tzatzagou; Maria Chini; Giulio Cavalli; Matteo Bassetti; Konstantina Katrini; Vasileios Kotsis; George Tsoukalas; Carlo Selmi; Ioannis Bliziotis; Michael Samarkos; Michael Doumas; Sofia Ktena; Aikaterini Masgala; Ilias Papanikolaou; Maria Kosmidou; Dimitra-Melia Myrodia; Aikaterini Argyraki; Chiara Simona Cardellino; Katerina Koliakou; Eleni-Ioanna Katsigianni; Vassiliki Rapti; Efthymia Giannitsioti; Antonella Cingolani; Styliani Micha; Karolina Akinosoglou; Orestis Liatsis-Douvitsas; Styliani Symbardi; Nikolaos Gatselis; Maria Mouktaroudi; Giuseppe Ippolito; Eleni Florou; Antigone Kotsaki; Mihai Netea; Jesper Eugen-Olsen; Miltiades Kyprianou; Periklis Panagopoulos; George Dalekos. Early Treatment of COVID-19 Pneumonia with Anakinra Guided by Urokinase Plasminogen Receptor. 2021, 1 .

AMA Style

Evangelos Giamarellos-Bourboulis, Evdoxia Kyriazopoulou, Garyfallia Poulakou, Haralampos Milionis, Simeon Metallidis, Georgios Adamis, Konstantinos Tsiakos, Archontoula Fragkou, Aggeliki Rapti, Christina Damoulari, Massimo Fantoni, Ioannis Kalomenidis, Georgios Chrysos, Andrea Angeheben, Ilias Kainis, Zoi Alexiou, Francesco Castelli, Francesco Saverio Serino, Maria Tsilika, Petros Bakakos, Emanuele Nicastri, Vassiliki Tzavara, Evangelos Kostis, Lorenzo Dagna, Panayiotis Koufargyris, Katerina Dimakou, Spyridon Savvanis, Glykeria Tzatzagou, Maria Chini, Giulio Cavalli, Matteo Bassetti, Konstantina Katrini, Vasileios Kotsis, George Tsoukalas, Carlo Selmi, Ioannis Bliziotis, Michael Samarkos, Michael Doumas, Sofia Ktena, Aikaterini Masgala, Ilias Papanikolaou, Maria Kosmidou, Dimitra-Melia Myrodia, Aikaterini Argyraki, Chiara Simona Cardellino, Katerina Koliakou, Eleni-Ioanna Katsigianni, Vassiliki Rapti, Efthymia Giannitsioti, Antonella Cingolani, Styliani Micha, Karolina Akinosoglou, Orestis Liatsis-Douvitsas, Styliani Symbardi, Nikolaos Gatselis, Maria Mouktaroudi, Giuseppe Ippolito, Eleni Florou, Antigone Kotsaki, Mihai Netea, Jesper Eugen-Olsen, Miltiades Kyprianou, Periklis Panagopoulos, George Dalekos. Early Treatment of COVID-19 Pneumonia with Anakinra Guided by Urokinase Plasminogen Receptor. . 2021; ():1.

Chicago/Turabian Style

Evangelos Giamarellos-Bourboulis; Evdoxia Kyriazopoulou; Garyfallia Poulakou; Haralampos Milionis; Simeon Metallidis; Georgios Adamis; Konstantinos Tsiakos; Archontoula Fragkou; Aggeliki Rapti; Christina Damoulari; Massimo Fantoni; Ioannis Kalomenidis; Georgios Chrysos; Andrea Angeheben; Ilias Kainis; Zoi Alexiou; Francesco Castelli; Francesco Saverio Serino; Maria Tsilika; Petros Bakakos; Emanuele Nicastri; Vassiliki Tzavara; Evangelos Kostis; Lorenzo Dagna; Panayiotis Koufargyris; Katerina Dimakou; Spyridon Savvanis; Glykeria Tzatzagou; Maria Chini; Giulio Cavalli; Matteo Bassetti; Konstantina Katrini; Vasileios Kotsis; George Tsoukalas; Carlo Selmi; Ioannis Bliziotis; Michael Samarkos; Michael Doumas; Sofia Ktena; Aikaterini Masgala; Ilias Papanikolaou; Maria Kosmidou; Dimitra-Melia Myrodia; Aikaterini Argyraki; Chiara Simona Cardellino; Katerina Koliakou; Eleni-Ioanna Katsigianni; Vassiliki Rapti; Efthymia Giannitsioti; Antonella Cingolani; Styliani Micha; Karolina Akinosoglou; Orestis Liatsis-Douvitsas; Styliani Symbardi; Nikolaos Gatselis; Maria Mouktaroudi; Giuseppe Ippolito; Eleni Florou; Antigone Kotsaki; Mihai Netea; Jesper Eugen-Olsen; Miltiades Kyprianou; Periklis Panagopoulos; George Dalekos. 2021. "Early Treatment of COVID-19 Pneumonia with Anakinra Guided by Urokinase Plasminogen Receptor." , no. : 1.

Brief report
Published: 16 June 2021 in Microorganisms
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Vaccination is the main public health measure to reduce SARS-CoV-2 transmission and hospitalization, and a massive worldwide scientific effort resulted in the rapid development of effective vaccines. This work aimed to define the dynamics of humoral and cell-mediated immune response in a cohort of health care workers (HCWs) who received a two-dose BNT162b2-mRNA vaccination. The serological response was evaluated by quantifying the anti-RBD and neutralizing antibodies. The cell-mediated response was performed by a whole blood test quantifying Th1 cytokines (IFN-γ, TNF-α, IL-2), produced in response to spike peptides. The BNT162b2-mRNA vaccine induced both humoral and cell-mediated immune responses against spike peptides in virtually all HCWs without previous SARS-CoV-2 infection, with a moderate inverse relation with age in the anti-RBD response. Spike-specific T cells produced several Th1 cytokines (IFN-γ, TNF-α, and IL-2), which correlated with the specific-serological response. Overall, our study describes the ability of the BNT162b2 mRNA vaccine to elicit a coordinated neutralizing humoral and spike-specific T cell response in HCWs. Assessing the dynamics of these parameters by an easy immune monitoring protocol can allow for the evaluation of the persistence of the vaccine response in order to define the optimal vaccination strategy.

ACS Style

Chiara Agrati; Concetta Castilletti; Delia Goletti; Silvia Meschi; Alessandra Sacchi; Giulia Matusali; Veronica Bordoni; Linda Petrone; Daniele Lapa; Stefania Notari; Valentina Vanini; Francesca Colavita; Alessandra Aiello; Alessandro Agresta; Chiara Farroni; Germana Grassi; Sara Leone; Francesco Vaia; Maria Capobianchi; Giuseppe Ippolito; Vincenzo Puro; on behalf of the INMI COVID-190 Vaccine Study Group. Coordinate Induction of Humoral and Spike Specific T-Cell Response in a Cohort of Italian Health Care Workers Receiving BNT162b2 mRNA Vaccine. Microorganisms 2021, 9, 1315 .

AMA Style

Chiara Agrati, Concetta Castilletti, Delia Goletti, Silvia Meschi, Alessandra Sacchi, Giulia Matusali, Veronica Bordoni, Linda Petrone, Daniele Lapa, Stefania Notari, Valentina Vanini, Francesca Colavita, Alessandra Aiello, Alessandro Agresta, Chiara Farroni, Germana Grassi, Sara Leone, Francesco Vaia, Maria Capobianchi, Giuseppe Ippolito, Vincenzo Puro, on behalf of the INMI COVID-190 Vaccine Study Group. Coordinate Induction of Humoral and Spike Specific T-Cell Response in a Cohort of Italian Health Care Workers Receiving BNT162b2 mRNA Vaccine. Microorganisms. 2021; 9 (6):1315.

Chicago/Turabian Style

Chiara Agrati; Concetta Castilletti; Delia Goletti; Silvia Meschi; Alessandra Sacchi; Giulia Matusali; Veronica Bordoni; Linda Petrone; Daniele Lapa; Stefania Notari; Valentina Vanini; Francesca Colavita; Alessandra Aiello; Alessandro Agresta; Chiara Farroni; Germana Grassi; Sara Leone; Francesco Vaia; Maria Capobianchi; Giuseppe Ippolito; Vincenzo Puro; on behalf of the INMI COVID-190 Vaccine Study Group. 2021. "Coordinate Induction of Humoral and Spike Specific T-Cell Response in a Cohort of Italian Health Care Workers Receiving BNT162b2 mRNA Vaccine." Microorganisms 9, no. 6: 1315.

Brief report
Published: 08 June 2021 in Vaccines
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Vaccination against SARS-CoV-2 is considered the most effective method of prevention to contain the pandemic. While highly effective SARS-CoV-2 vaccines are being applied on a large-scale, whether and to what extent the strength of the vaccine-induced immune response could be further potentiated is still an object of debate. Several reports studied the effect of different vaccines on the susceptibility and mortality of COVID-19, with conflicting results. We aimed to evaluate whether previous influenza and/or pneumococcal vaccination had an impact on the specific immune response to the SARS-CoV-2 BNT162b2 mRNA vaccine. The study population consists of 710 workers from our Institute who completed the BNT162b2 schedule and have been tested at least once after the second dose, from 27 December 2020 up to 15 April 2021. Of these, 152 (21.4%) had received an influenza and 215 (30.3%) a concomitant influenza and pneumococcal vaccination, a median of 102 days before the second dose of BNT162b2. Overall, 100% of workers were tested for anti-Spike receptor-binding domain (anti-S/RBD) antibodies, 224 workers for neutralization titer (Micro-neutralization assay, MNA), and 155 workers for a spike-specific T cell interferon-γ response (IFN-γ). The levels of anti-S/RBD, MNA and IFN-γ were evaluated and compared according to sex, age, involvement in direct care of COVID-19 patients, and previous influenza/pneumococcal vaccination. At the univariate analysis, no statistically significant association was observed with regard to a previous influenza and pneumococcal vaccination. A significant lower anti-S/RBD response was observed according to an older age and male sex, while MNA titers were significantly associated to sex but not to age. At the multivariable analysis, workers receiving a concomitant influenza and pneumococcal vaccination or only influenza showed a 58% (p 0.01) and 42% (p 0.07) increase in MNA titers, respectively, compared to those who did not receive an influenza/pneumococcal vaccination. Female workers showed an 81% MNA and a 44% anti-S/RBD increase compared to male workers (p< 0.001). Compared to workers aged 21 to 49 years, those aged 50 or older were associated with a reduction in the anti-S/RBD (16%; p 0.005), MNA (31%; p 0.019), and IFN.g (32%) immune response. Maintaining the influenza and pneumococcal immunization program for the coming season, in which COVID-19 could still be spreading, remains strongly recommended to protect those who are more vulnerable and to limit the potential burden of these infections on the healthcare system.

ACS Style

Vincenzo Puro; Concetta Castilletti; Chiara Agrati; Delia Goletti; Sara Leone; Alessandro Agresta; Eleonora Cimini; Eleonora Tartaglia; Rita Casetti; Francesca Colavita; Silvia Meschi; Giulia Matusali; Daniele Lapa; Saeid Najafi Fard; Alessandra Aiello; Chiara Farrone; Paola Gallì; Maria Capobianchi; Giuseppe Ippolito; on behalf of the INMI COVID-19 Vaccine Study Group. Impact of Prior Influenza and Pneumoccocal Vaccines on Humoral and Cellular Response to SARS-CoV-2 BNT162b2 Vaccination. Vaccines 2021, 9, 615 .

AMA Style

Vincenzo Puro, Concetta Castilletti, Chiara Agrati, Delia Goletti, Sara Leone, Alessandro Agresta, Eleonora Cimini, Eleonora Tartaglia, Rita Casetti, Francesca Colavita, Silvia Meschi, Giulia Matusali, Daniele Lapa, Saeid Najafi Fard, Alessandra Aiello, Chiara Farrone, Paola Gallì, Maria Capobianchi, Giuseppe Ippolito, on behalf of the INMI COVID-19 Vaccine Study Group. Impact of Prior Influenza and Pneumoccocal Vaccines on Humoral and Cellular Response to SARS-CoV-2 BNT162b2 Vaccination. Vaccines. 2021; 9 (6):615.

Chicago/Turabian Style

Vincenzo Puro; Concetta Castilletti; Chiara Agrati; Delia Goletti; Sara Leone; Alessandro Agresta; Eleonora Cimini; Eleonora Tartaglia; Rita Casetti; Francesca Colavita; Silvia Meschi; Giulia Matusali; Daniele Lapa; Saeid Najafi Fard; Alessandra Aiello; Chiara Farrone; Paola Gallì; Maria Capobianchi; Giuseppe Ippolito; on behalf of the INMI COVID-19 Vaccine Study Group. 2021. "Impact of Prior Influenza and Pneumoccocal Vaccines on Humoral and Cellular Response to SARS-CoV-2 BNT162b2 Vaccination." Vaccines 9, no. 6: 615.

Journal article
Published: 31 May 2021 in Scientific Reports
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Prophylactic low molecular weight heparin (pLMWH) is currently recommended in COVID-19 to reduce the risk of coagulopathy. The aim of this study was to evaluate whether the antinflammatory effects of pLMWH could translate in lower rate of clinical progression in patients with COVID-19 pneumonia. Patients admitted to a COVID-hospital in Rome with SARS-CoV-2 infection and mild/moderate pneumonia were retrospectively evaluated. The primary endpoint was the time from hospital admission to orotracheal intubation/death (OTI/death). A total of 449 patients were included: 39% female, median age 63 (IQR, 50–77) years. The estimated probability of OTI/death for patients receiving pLMWH was: 9.5% (95% CI 3.2–26.4) by day 20 in those not receiving pLMWH vs. 10.4% (6.7–15.9) in those exposed to pLMWH; p-value = 0.144. This risk associated with the use of pLMWH appeared to vary by PaO2/FiO2 ratio: aHR 1.40 (95% CI 0.51–3.79) for patients with an admission PaO2/FiO2 ≤ 300 mmHg and 0.27 (0.03–2.18) for those with PaO2/FiO2 > 300 mmHg; p-value at interaction test 0.16. pLMWH does not seem to reduce the risk of OTI/death mild/moderate COVID-19 pneumonia, especially when respiratory function had already significantly deteriorated. Data from clinical trials comparing the effect of prophylactic vs. therapeutic dosage of LMWH at various stages of COVID-19 disease are needed.

ACS Style

Alessandra Vergori; The ReCOVeRI Study Group; Patrizia Lorenzini; Alessandro Cozzi-Lepri; Davide Roberto Donno; Gina Gualano; Emanuele Nicastri; Fabio Iacomi; Luisa Marchioni; Paolo Campioni; Vincenzo Schininà; Stefania Cicalini; Chiara Agrati; Maria Rosaria Capobianchi; Enrico Girardi; Giuseppe Ippolito; Francesco Vaia; Nicola Petrosillo; Andrea Antinori; Fabrizio Taglietti. Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia. Scientific Reports 2021, 11, 11334 .

AMA Style

Alessandra Vergori, The ReCOVeRI Study Group, Patrizia Lorenzini, Alessandro Cozzi-Lepri, Davide Roberto Donno, Gina Gualano, Emanuele Nicastri, Fabio Iacomi, Luisa Marchioni, Paolo Campioni, Vincenzo Schininà, Stefania Cicalini, Chiara Agrati, Maria Rosaria Capobianchi, Enrico Girardi, Giuseppe Ippolito, Francesco Vaia, Nicola Petrosillo, Andrea Antinori, Fabrizio Taglietti. Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia. Scientific Reports. 2021; 11 (1):11334.

Chicago/Turabian Style

Alessandra Vergori; The ReCOVeRI Study Group; Patrizia Lorenzini; Alessandro Cozzi-Lepri; Davide Roberto Donno; Gina Gualano; Emanuele Nicastri; Fabio Iacomi; Luisa Marchioni; Paolo Campioni; Vincenzo Schininà; Stefania Cicalini; Chiara Agrati; Maria Rosaria Capobianchi; Enrico Girardi; Giuseppe Ippolito; Francesco Vaia; Nicola Petrosillo; Andrea Antinori; Fabrizio Taglietti. 2021. "Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia." Scientific Reports 11, no. 1: 11334.

Journal article
Published: 14 May 2021 in Cells
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Autophagy is a lysosomal-dependent degradative mechanism essential in maintaining cellular homeostasis, but it is also considered an ancient form of innate eukaryotic fighting against invading microorganisms. Mounting evidence has shown that HIV-1 is a critical target of autophagy that plays a role in HIV-1 replication and disease progression. In a special subset of HIV-1-infected patients that spontaneously and durably maintain extremely low viral replication, namely, long-term nonprogressors (LTNP), the resistance to HIV-1-induced pathogenesis is accompanied, in vivo, by a significant increase in the autophagic activity in peripheral blood mononuclear cells. Recently, a new player in the battle of autophagy against HIV-1 has been identified, namely, tripartite motif protein 5α (TRIM5α). In vitro data demonstrated that TRIM5α directly recognizes HIV-1 and targets it for autophagic destruction, thus protecting cells against HIV-1 infection. In this paper, we analyzed the involvement of this factor in the control of HIV-1 infection through autophagy, in vivo, in LTNP. The results obtained showed significantly higher levels of TRIM5α expression in cells from LTNP with respect to HIV-1-infected normal progressor patients. Interestingly, the colocalization of TRIM5α and HIV-1 proteins in autophagic vacuoles in LTNP cells suggested the participation of TRIM5α in the autophagy containment of HIV-1 in LTNP. Altogether, our results point to a protective role of TRIM5α in the successful control of the chronic viral infection in HIV-1-controllers through the autophagy mechanism. In our opinion, these findings could be relevant in fighting against HIV-1 disease, because autophagy inducers might be employed in combination with antiretroviral drugs.

ACS Style

Fabiola Ciccosanti; Marco Corazzari; Rita Casetti; Alessandra Amendola; Diletta Collalto; Giulia Refolo; Alessandra Vergori; Chiara Taibi; Gianpiero D’Offizi; Andrea Antinori; Chiara Agrati; Gian Fimia; Giuseppe Ippolito; Mauro Piacentini; Roberta Nardacci. High Levels of TRIM5α Are Associated with Xenophagy in HIV-1-Infected Long-Term Nonprogressors. Cells 2021, 10, 1207 .

AMA Style

Fabiola Ciccosanti, Marco Corazzari, Rita Casetti, Alessandra Amendola, Diletta Collalto, Giulia Refolo, Alessandra Vergori, Chiara Taibi, Gianpiero D’Offizi, Andrea Antinori, Chiara Agrati, Gian Fimia, Giuseppe Ippolito, Mauro Piacentini, Roberta Nardacci. High Levels of TRIM5α Are Associated with Xenophagy in HIV-1-Infected Long-Term Nonprogressors. Cells. 2021; 10 (5):1207.

Chicago/Turabian Style

Fabiola Ciccosanti; Marco Corazzari; Rita Casetti; Alessandra Amendola; Diletta Collalto; Giulia Refolo; Alessandra Vergori; Chiara Taibi; Gianpiero D’Offizi; Andrea Antinori; Chiara Agrati; Gian Fimia; Giuseppe Ippolito; Mauro Piacentini; Roberta Nardacci. 2021. "High Levels of TRIM5α Are Associated with Xenophagy in HIV-1-Infected Long-Term Nonprogressors." Cells 10, no. 5: 1207.

Preprint content
Published: 05 May 2021
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Patients with cancer are at higher risk of severe coronavirus infectious disease 2019 (COVID-19), but the mechanisms underlying virus-host interactions during cancer therapies remain elusive. When comparing nasopharyngeal swabs from cancer and non-cancer patients for RT-qPCR cycle thresholds measuring acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in 1063 patients (58% with cancer, 89% COVID-19+), we found that malignant disease favors the magnitude and duration of viral RNA shedding concomitant with prolonged serum elevations of type 1 IFN that anticorrelated with anti-RBD IgG antibodies. Chronic viral RNA carriers exhibited the typical immunopathology of severe COVID-19 at the early phase of infection including circulation of immature neutrophils, depletion of non-conventional monocytes and a general lymphopenia that, however, was accompanied by a rise in plasmablasts, activated follicular T helper cells, and non-naive Granzyme B+ FasL+, EomehighTCF-1high, PD-1+CD8+ Tc1 cells. Virus-induced lymphopenia worsened cancer-associated lymphocyte loss, and low lymphocyte counts correlated with chronic SARS-CoV-2 RNA shedding, COVID-19 severity and a higher risk of cancer-related death in the first and second surge of the pandemic. Lymphocyte loss correlated with significant changes in metabolites from the polyamine and biliary salt pathways as well as increased blood DNA from Enterobacteriaceae and Micrococcaceae gut family members in long term viral carriers. We surmise that cancer therapies may exacerbate the paradoxical association between lymphopenia and COVID-19-related immunopathology, and that the prevention of COVID-19-induced lymphocyte loss may reduce cancer-associated death.

ACS Style

Anne-Gaëlle Goubet; Agathe Dubuisson; Arthur Geraud; François-Xavier Danlos; Safae Terrisse; Carolina Alves Costa Silva; Damien Drubay; Lea Touri; Marion Picard; Marine Mazzenga; Aymeric Silvin; Garett Dunsmore; Yacine Haddad; Eugenie Pizzato; Pierre Ly; Caroline Flament; Cléa Melenotte; Eric Solary; Michaela Fontenay; Gabriel Garcia; Corinne Balleyguier; Nathalie Lassau; Markus Maeurer; Claudia Grajeda-Iglesias; Nitharsshini Nirmalathasan; Fanny Aprahamian; Sylvère Durand; Oliver Kepp; Gladys Ferrere; Cassandra Thelemaque; Imran Lahmar; Jean-Eudes Fahrner; Lydia Meziani; Abdelhakim Ahmed-Belkacem; Nadia Saïdani; Bernard La Scola; Didier Raoult; Stéphanie Gentile; Sébastien Cortaredona; Giuseppe Ippolito; Benjamin Lelouvier; Alain Roulet; Fabrice Andre; Fabrice Barlesi; Jean-Charles Soria; Caroline Pradon; Emmanuelle Gallois; Fanny Pommeret; Emeline Colomba; Florent Ginhoux; Suzanne Kazandjian; Arielle Elkrief; Bertrand Routy; Makoto Miyara; Guy Gorochov; Eric Deutsch; Laurence Albiges; Annabelle Stoclin; Bertrand Gachot; Anne Florin; Mansouria Merad; Florian Scotte; Souad Assaad; Guido Kroemer; Jean-Yves Blay; Aurélien Marabelle; Frank Griscelli; Laurence Zitvogel; Lisa Derosa. Prolonged SARS-CoV-2 RNA virus shedding and lymphopenia are hallmarks of COVID-19 in cancer patients with poor prognosis. 2021, 1 .

AMA Style

Anne-Gaëlle Goubet, Agathe Dubuisson, Arthur Geraud, François-Xavier Danlos, Safae Terrisse, Carolina Alves Costa Silva, Damien Drubay, Lea Touri, Marion Picard, Marine Mazzenga, Aymeric Silvin, Garett Dunsmore, Yacine Haddad, Eugenie Pizzato, Pierre Ly, Caroline Flament, Cléa Melenotte, Eric Solary, Michaela Fontenay, Gabriel Garcia, Corinne Balleyguier, Nathalie Lassau, Markus Maeurer, Claudia Grajeda-Iglesias, Nitharsshini Nirmalathasan, Fanny Aprahamian, Sylvère Durand, Oliver Kepp, Gladys Ferrere, Cassandra Thelemaque, Imran Lahmar, Jean-Eudes Fahrner, Lydia Meziani, Abdelhakim Ahmed-Belkacem, Nadia Saïdani, Bernard La Scola, Didier Raoult, Stéphanie Gentile, Sébastien Cortaredona, Giuseppe Ippolito, Benjamin Lelouvier, Alain Roulet, Fabrice Andre, Fabrice Barlesi, Jean-Charles Soria, Caroline Pradon, Emmanuelle Gallois, Fanny Pommeret, Emeline Colomba, Florent Ginhoux, Suzanne Kazandjian, Arielle Elkrief, Bertrand Routy, Makoto Miyara, Guy Gorochov, Eric Deutsch, Laurence Albiges, Annabelle Stoclin, Bertrand Gachot, Anne Florin, Mansouria Merad, Florian Scotte, Souad Assaad, Guido Kroemer, Jean-Yves Blay, Aurélien Marabelle, Frank Griscelli, Laurence Zitvogel, Lisa Derosa. Prolonged SARS-CoV-2 RNA virus shedding and lymphopenia are hallmarks of COVID-19 in cancer patients with poor prognosis. . 2021; ():1.

Chicago/Turabian Style

Anne-Gaëlle Goubet; Agathe Dubuisson; Arthur Geraud; François-Xavier Danlos; Safae Terrisse; Carolina Alves Costa Silva; Damien Drubay; Lea Touri; Marion Picard; Marine Mazzenga; Aymeric Silvin; Garett Dunsmore; Yacine Haddad; Eugenie Pizzato; Pierre Ly; Caroline Flament; Cléa Melenotte; Eric Solary; Michaela Fontenay; Gabriel Garcia; Corinne Balleyguier; Nathalie Lassau; Markus Maeurer; Claudia Grajeda-Iglesias; Nitharsshini Nirmalathasan; Fanny Aprahamian; Sylvère Durand; Oliver Kepp; Gladys Ferrere; Cassandra Thelemaque; Imran Lahmar; Jean-Eudes Fahrner; Lydia Meziani; Abdelhakim Ahmed-Belkacem; Nadia Saïdani; Bernard La Scola; Didier Raoult; Stéphanie Gentile; Sébastien Cortaredona; Giuseppe Ippolito; Benjamin Lelouvier; Alain Roulet; Fabrice Andre; Fabrice Barlesi; Jean-Charles Soria; Caroline Pradon; Emmanuelle Gallois; Fanny Pommeret; Emeline Colomba; Florent Ginhoux; Suzanne Kazandjian; Arielle Elkrief; Bertrand Routy; Makoto Miyara; Guy Gorochov; Eric Deutsch; Laurence Albiges; Annabelle Stoclin; Bertrand Gachot; Anne Florin; Mansouria Merad; Florian Scotte; Souad Assaad; Guido Kroemer; Jean-Yves Blay; Aurélien Marabelle; Frank Griscelli; Laurence Zitvogel; Lisa Derosa. 2021. "Prolonged SARS-CoV-2 RNA virus shedding and lymphopenia are hallmarks of COVID-19 in cancer patients with poor prognosis." , no. : 1.

Review
Published: 26 April 2021 in International Journal of Molecular Sciences
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Angiotensin-converting enzyme 2 (ACE2) is the entry receptor for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of Coronavirus Disease-2019 (COVID-19) in humans. ACE-2 is a type I transmembrane metallocarboxypeptidase expressed in vascular endothelial cells, alveolar type 2 lung epithelial cells, renal tubular epithelium, Leydig cells in testes and gastrointestinal tract. ACE2 mediates the interaction between host cells and SARS-CoV-2 spike (S) protein. However, ACE2 is not only a SARS-CoV-2 receptor, but it has also an important homeostatic function regulating renin-angiotensin system (RAS), which is pivotal for both the cardiovascular and immune systems. Therefore, ACE2 is the key link between SARS-CoV-2 infection, cardiovascular diseases (CVDs) and immune response. Susceptibility to SARS-CoV-2 seems to be tightly associated with ACE2 availability, which in turn is determined by genetics, age, gender and comorbidities. Severe COVID-19 is due to an uncontrolled and excessive immune response, which leads to acute respiratory distress syndrome (ARDS) and multi-organ failure. In spite of a lower ACE2 expression on cells surface, patients with CVDs have a higher COVID-19 mortality rate, which is likely driven by the imbalance between ADAM metallopeptidase domain 17 (ADAM17) protein (which is required for cleavage of ACE-2 ectodomain resulting in increased ACE2 shedding), and TMPRSS2 (which is required for spike glycoprotein priming). To date, ACE inhibitors and Angiotensin II Receptor Blockers (ARBs) treatment interruption in patients with chronic comorbidities appears unjustified. The rollout of COVID-19 vaccines provides opportunities to study the effects of different COVID-19 vaccines on ACE2 in patients on treatment with ACEi/ARB.

ACS Style

Aneta Aleksova; Giulia Gagno; Gianfranco Sinagra; Antonio Beltrami; Milijana Janjusevic; Giuseppe Ippolito; Alimuddin Zumla; Alessandra Fluca; Federico Ferro. Effects of SARS-CoV-2 on Cardiovascular System: The Dual Role of Angiotensin-Converting Enzyme 2 (ACE2) as the Virus Receptor and Homeostasis Regulator-Review. International Journal of Molecular Sciences 2021, 22, 4526 .

AMA Style

Aneta Aleksova, Giulia Gagno, Gianfranco Sinagra, Antonio Beltrami, Milijana Janjusevic, Giuseppe Ippolito, Alimuddin Zumla, Alessandra Fluca, Federico Ferro. Effects of SARS-CoV-2 on Cardiovascular System: The Dual Role of Angiotensin-Converting Enzyme 2 (ACE2) as the Virus Receptor and Homeostasis Regulator-Review. International Journal of Molecular Sciences. 2021; 22 (9):4526.

Chicago/Turabian Style

Aneta Aleksova; Giulia Gagno; Gianfranco Sinagra; Antonio Beltrami; Milijana Janjusevic; Giuseppe Ippolito; Alimuddin Zumla; Alessandra Fluca; Federico Ferro. 2021. "Effects of SARS-CoV-2 on Cardiovascular System: The Dual Role of Angiotensin-Converting Enzyme 2 (ACE2) as the Virus Receptor and Homeostasis Regulator-Review." International Journal of Molecular Sciences 22, no. 9: 4526.

Case report
Published: 23 April 2021 in International Journal of Infectious Diseases
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Prolonged B-cell depletion due to anti-CD20 monoclonal antibody (mAbs) therapy impairs the adaptive immune response, causing severe manifestations during COronaVIrus Disease-2019 (COVID-19). The cases of two patients under anti-CD20 therapy who experienced prolonged and severe COVID-19 successfully treated with mAbs against Severe Acute Respiratory Syndrome-CoV-2 spike proteins are reported.

ACS Style

Alessandra D’Abramo; Serena Vita; Gaetano Maffongelli; Andrea Mariano; Chiara Agrati; Concetta Castilletti; Delia Goletti; Giuseppe Ippolito; Emanuele Nicastri. Prolonged and severe SARS-CoV-2 infection in patients under B-cell-depleting drug successfully treated: A tailored approach. International Journal of Infectious Diseases 2021, 107, 247 -250.

AMA Style

Alessandra D’Abramo, Serena Vita, Gaetano Maffongelli, Andrea Mariano, Chiara Agrati, Concetta Castilletti, Delia Goletti, Giuseppe Ippolito, Emanuele Nicastri. Prolonged and severe SARS-CoV-2 infection in patients under B-cell-depleting drug successfully treated: A tailored approach. International Journal of Infectious Diseases. 2021; 107 ():247-250.

Chicago/Turabian Style

Alessandra D’Abramo; Serena Vita; Gaetano Maffongelli; Andrea Mariano; Chiara Agrati; Concetta Castilletti; Delia Goletti; Giuseppe Ippolito; Emanuele Nicastri. 2021. "Prolonged and severe SARS-CoV-2 infection in patients under B-cell-depleting drug successfully treated: A tailored approach." International Journal of Infectious Diseases 107, no. : 247-250.

Preprint content
Published: 13 April 2021
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Safe and effective vaccines against coronavirus disease 2019 (COVID-19) are urgently needed to control the ongoing pandemic. Although impressive progress has been made with several COVID-19 vaccines already approved, it is clear that those developed so far cannot meet the global vaccine demand. We have developed a COVID-19 vaccine based on a replication-defective gorilla adenovirus expressing the stabilized pre-fusion SARS-CoV-2 Spike protein, named GRAd-COV2. We aimed to assess the safety and immunogenicity of a single-dose regimen of this vaccine in healthy younger and older adults to select the appropriate dose for each age group. To this purpose, a phase 1, dose-escalation, open-label trial was conducted including 90 healthy subjects, (45 aged 18-55 years and 45 aged 65-85 years), who received a single intramuscular administration of GRAd-CoV2 at three escalating doses. Local and systemic adverse reactions were mostly mild or moderate and of short duration, and no serious AE was reported. Four weeks after vaccination, seroconversion to Spike/RBD was achieved in 43/44 young volunteers and in 45/45 older subjects. Consistently, neutralizing antibodies were detected in 42/44 younger age and 45/45 older age volunteers. In addition, GRAd-COV2 induced a robust and Th1-skewed T cell response against the S antigen in 89/90 subjects from both age groups. Overall, the safety and immunogenicity data from the phase 1 trial support further development of this vaccine.

ACS Style

Simone Lanini; Stefania Capone; Andrea Antinori; Stefano Milleri; Emanuele Nicastri; Roberto Camerini; Chiara Agrati; Concetta Castilletti; Federica Mori; Alessandra Sacchi; Giulia Matusali; Roberta Gagliardini; Virginia Ammendola; Eleonora Cimini; Fabiana Grazioli; Laura Scorzolini; Federico Napolitano; Maria Maddalena Plazzi; Marco Soriani; Aldo De Luca; Simone Battella; Andrea Sommella; Alessandra Maria Contino; Federica Barra; Michela Gentile; Angelo Raggioli; Youfang Shi; Enrico Girardi; Markus Maeurer; Maria Rosaria Capobianchi; Francesco Vaia; Mauro Piacentini; Guido Kroemer; Alessandra Vitelli; Stefano Colloca; Antonella Folgori; Giuseppe Ippolito. GRAd-COV2, a gorilla adenovirus based candidate vaccine against COVID-19, is safe and immunogenic in young and older adults. 2021, 1 .

AMA Style

Simone Lanini, Stefania Capone, Andrea Antinori, Stefano Milleri, Emanuele Nicastri, Roberto Camerini, Chiara Agrati, Concetta Castilletti, Federica Mori, Alessandra Sacchi, Giulia Matusali, Roberta Gagliardini, Virginia Ammendola, Eleonora Cimini, Fabiana Grazioli, Laura Scorzolini, Federico Napolitano, Maria Maddalena Plazzi, Marco Soriani, Aldo De Luca, Simone Battella, Andrea Sommella, Alessandra Maria Contino, Federica Barra, Michela Gentile, Angelo Raggioli, Youfang Shi, Enrico Girardi, Markus Maeurer, Maria Rosaria Capobianchi, Francesco Vaia, Mauro Piacentini, Guido Kroemer, Alessandra Vitelli, Stefano Colloca, Antonella Folgori, Giuseppe Ippolito. GRAd-COV2, a gorilla adenovirus based candidate vaccine against COVID-19, is safe and immunogenic in young and older adults. . 2021; ():1.

Chicago/Turabian Style

Simone Lanini; Stefania Capone; Andrea Antinori; Stefano Milleri; Emanuele Nicastri; Roberto Camerini; Chiara Agrati; Concetta Castilletti; Federica Mori; Alessandra Sacchi; Giulia Matusali; Roberta Gagliardini; Virginia Ammendola; Eleonora Cimini; Fabiana Grazioli; Laura Scorzolini; Federico Napolitano; Maria Maddalena Plazzi; Marco Soriani; Aldo De Luca; Simone Battella; Andrea Sommella; Alessandra Maria Contino; Federica Barra; Michela Gentile; Angelo Raggioli; Youfang Shi; Enrico Girardi; Markus Maeurer; Maria Rosaria Capobianchi; Francesco Vaia; Mauro Piacentini; Guido Kroemer; Alessandra Vitelli; Stefano Colloca; Antonella Folgori; Giuseppe Ippolito. 2021. "GRAd-COV2, a gorilla adenovirus based candidate vaccine against COVID-19, is safe and immunogenic in young and older adults." , no. : 1.

Journal article
Published: 10 April 2021 in Viruses
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SARS-CoV-2 serum neutralization assay represents the gold standard for assessing antibody-mediated protection in naturally infected and vaccinated individuals. In the present study, 662 serum samples collected from February 2020 to January 2021 from acute and convalescent COVID-19 patients were tested to determine neutralizing antibody (NAb) titers using a microneutralization test (MNT) for live SARS-CoV-2. Moreover, anti-SARS-CoV-2 IgG, IgA, and IgM directed against different viral antigens were measured by high-throughput automated platforms. We observed higher levels of NAbs in elderly (>60 years old) individuals and in patients presenting acute respiratory distress syndrome. SARS-CoV-2 NAbs develop as soon as five days from symptom onset and, despite a decline after the second month, persist for over 11 months, showing variable dynamics. Through correlation and receiver operating characteristic (ROC) curve analysis, we set up a testing algorithm, suitable for the laboratory workload, by establishing an optimal cutoff value of anti-SARS-CoV-2 IgG for convalescent plasma donors to exclude from MNT samples foreseen to have low/negative NAb titers and ineligible for plasma donation. Overall, MNT, although cumbersome and not suitable for routine testing of large sample sizes, remains the reference tool for the assessment of antibody-mediated immunity after SARS-CoV-2 infection. Smart testing algorithms may optimize the laboratory workflow to monitor antibody-mediated protection in COVID-19 patients, plasma donors, and vaccinated individuals.

ACS Style

Giulia Matusali; Francesca Colavita; Daniele Lapa; Silvia Meschi; Licia Bordi; Pierluca Piselli; Roberta Gagliardini; Angela Corpolongo; Emanuele Nicastri; Andrea Antinori; Giuseppe Ippolito; Maria Rosaria Capobianchi; Concetta Castilletti. SARS-CoV-2 Serum Neutralization Assay: A Traditional Tool for a Brand-New Virus. Viruses 2021, 13, 655 .

AMA Style

Giulia Matusali, Francesca Colavita, Daniele Lapa, Silvia Meschi, Licia Bordi, Pierluca Piselli, Roberta Gagliardini, Angela Corpolongo, Emanuele Nicastri, Andrea Antinori, Giuseppe Ippolito, Maria Rosaria Capobianchi, Concetta Castilletti. SARS-CoV-2 Serum Neutralization Assay: A Traditional Tool for a Brand-New Virus. Viruses. 2021; 13 (4):655.

Chicago/Turabian Style

Giulia Matusali; Francesca Colavita; Daniele Lapa; Silvia Meschi; Licia Bordi; Pierluca Piselli; Roberta Gagliardini; Angela Corpolongo; Emanuele Nicastri; Andrea Antinori; Giuseppe Ippolito; Maria Rosaria Capobianchi; Concetta Castilletti. 2021. "SARS-CoV-2 Serum Neutralization Assay: A Traditional Tool for a Brand-New Virus." Viruses 13, no. 4: 655.

Journal article
Published: 02 April 2021 in Journal of Clinical Medicine
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Diagnostic methods based on SARS-CoV-2 antigens detection are a promising alternative to SARS-CoV-2 RNA amplification. We evaluated the automated chemiluminescence-based Lumipulse® G SARS-CoV-2 Ag assay on saliva samples, using Simplexa™ COVID-19 Direct assay as a reference test. Analytical performance was established on a pool of healthy donors’ saliva samples spiked with the 2019-nCoV/Italy-INMI1 isolate, whereas clinical performance was assessed on fresh saliva specimens collected from hospitalized patients with suspect or confirmed COVID-19 diagnosis. The limit of detection (LOD) was 0.65 Log TCID50/mL, corresponding to 18,197 copies/mL of SARS-CoV-2 RNA. Antigen concentrations and SARS-CoV-2 RNA were highly correlated (r = 0.99; p < 0.0001). Substantial agreement (80.3%) and significant correlation (r = −0.675; p = 0.0006) were observed between Lumipulse® G assay results and Ct values on clinical samples, with 52.4% sensitivity and specificity 94.1%. Sensitivity exceeded 90.0% when calculated on samples with Ct < 25, and specificity was 100% when excluding samples from recovered patients with previous COVID-19 diagnosis. Overall, chemiluminescence-based antigen assay may be reliably applied to saliva samples to identify individuals with high viral loads, more likely to transmit the virus. However, the low positive predictive value in a context of low SARS-CoV-2 prevalence underscores the need for confirmatory testing in SARS-CoV-2 antigen-positive cases.

ACS Style

Alessandra Amendola; Giuseppe Sberna; Eleonora Lalle; Francesca Colavita; Concetta Castilletti; Giulia Menchinelli; Brunella Posteraro; Maurizio Sanguinetti; Giuseppe Ippolito; Licia Bordi; Maria Capobianchi; on behalf of INMI COVID-19 Study Group. Saliva Is a Valid Alternative to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detection of SARS-CoV-2 Antigen. Journal of Clinical Medicine 2021, 10, 1471 .

AMA Style

Alessandra Amendola, Giuseppe Sberna, Eleonora Lalle, Francesca Colavita, Concetta Castilletti, Giulia Menchinelli, Brunella Posteraro, Maurizio Sanguinetti, Giuseppe Ippolito, Licia Bordi, Maria Capobianchi, on behalf of INMI COVID-19 Study Group. Saliva Is a Valid Alternative to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detection of SARS-CoV-2 Antigen. Journal of Clinical Medicine. 2021; 10 (7):1471.

Chicago/Turabian Style

Alessandra Amendola; Giuseppe Sberna; Eleonora Lalle; Francesca Colavita; Concetta Castilletti; Giulia Menchinelli; Brunella Posteraro; Maurizio Sanguinetti; Giuseppe Ippolito; Licia Bordi; Maria Capobianchi; on behalf of INMI COVID-19 Study Group. 2021. "Saliva Is a Valid Alternative to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detection of SARS-CoV-2 Antigen." Journal of Clinical Medicine 10, no. 7: 1471.