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1. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., and Marcellini V.

Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3 weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific T cell response peaks after the first dose and is characterized by high frequencies of CD8s. T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Published
2023

2. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, Stefania, Fusco, Francesco M, Milleri, Stefano, Borrè, Silvio, Carbonara, Sergio, Lo Caputo, Sergio, Leone, Sebastiano, Gori, Giovanni, Maggi, Paolo, Cascio, Antonio, Lichtner, Miriam, Cauda, Roberto, Dal Zoppo, Sarah, Cossu, Maria V, Gori, Andrea, Roda, Silvia, Confalonieri, Paola, Bonora, Stefano, Missale, Gabriele, Codeluppi, Mauro, Mezzaroma, Ivano, Capici, Serena, Pontali, Emanuele, Libanore, Marco, Diani, Augusta, Lanini, Simone, Battella, Simone, Contino, Alessandra M, Piano Mortari, Eva, Genova, Francesco, Parente, Gessica, Dragonetti, Rosella, Colloca, Stefano, Visani, Luigi, Iannacone, Claudio, Carsetti, Rita, Folgori, Antonella, Camerini, Roberto, Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, and Marcellini, V

Subjects
immunological memory, phase 2 clinical trial, safety, Sars-CoV-2 vaccine, COVID-19, CD8, T cell response, simian adenoviral vector, General Biochemistry, Genetics and Molecular Biology, CD4, neutralizing antibodie
Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific Tcell response peaks after the first dose and is characterized by high frequencies of CD8s. Tcells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Published
2023

4. Identification of an inflammation-associated psychosis onset subgroup by applying unsupervised machine learning to whole-blood expression levels of immune gene transcripts

Author

Enrico, P., Delvecchio, G., Turtulici, N., Aronica, R., Pigoni, A., Squarcina, L., Villa, F.M., Perlini, C., Rossetti, M.G., Lasalvia, A., Bonetto, C., Scocco, P., D'Agostino, A., Torresani, S., Imbesi, M., Bellini, F., Veronese, A., Bocchio-Chiavetto, L., Gennarelli, M., Balestrieri, M., Colombo, G.I., Finardi, A., Ruggeri, M., Furlan, R., and Brambilla, P.

Published
2022
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6. Arterial and venous thrombosis in coronavirus 2019 disease (Covid-19):relationship with mortality

Author

Violi, F., Ceccarelli, G., Cangemi, R., Cipollone, F., D'Ardes, D., Oliva, A., Pirro, M., Rocco, M., Alessandri, F., D'Ettorre, G., Lichtner, M., Pignatelli, P., Ferro, D., Ruberto, F., Lip, G. Y. H., Pugliese, F., Mastroianni, C. M., Albante, A., Auricchio, D., De Lazzaro, F., M. De Lauri D., Di Santo, C., Ianni, S., Magnanimi, E., Ratini, F., Sabani, A., Titi, L., Vaccaro, P., Giordano, G., Manganelli, C., Mancone, M., Bruno, K., Celli, P., Consolo, S., Croce, C., Giannetti, L., Martelli, S., Messina, T., Pattelli, E., Perrella, S., Portieri, M., Ricci, C., Almenrader, N., Arzilla, R., Delia, E., Di Giovanni, C., Laderchi, A., Macri, C., Marandola, M., Nardecchia, G., Pacilli, M., Pacini, F., Araimo Morselli, F., Imperiale, C., Tordiglione, P., Ciardi, M. R., Ajassa, C., D'Agostino, C., Russo, G., Trinchieri, V., Guariglia, P., Antonelli, L., Cuomo, R. M., Carnevalini, M., Mastropietro, C., Iaiani, G., Mezzaroma, I., Falciano, M., Brogi, A., Celani, L., Cavallari, N. E., Rivano Capparuccia, M., Massetti, A. P., Fimiani, C., Santori, M., Bianchi, A., Franchi, C., De Angelis, M., Sereno, S., Furlan, C., De Sanctis, G., Paoletti, F., Pasculli, P., Cogliati Dezza, F., Vassalini, P., Cancelli, F., De Girolamo, G., Savelloni, G., Valeri, S., Siccardi, G., Alessi, F., Recchia, G., Ridolfi, M., Romani, F. E., Aronica, R., Filippi, V., Vera, M., Volpicelli, L., Candy, M., Alban, R., Di Bari, S., Gavaruzzi, F., Casali, E., Carli, M. S., Zingaropoli, A. M., Perri, V., Santinelli, L., Pinacchio, C., Nijhawan, P., Miele, C. M., Innocenti, P. G., and Mengoni, F.

Subjects
Male, covid-19, mortality, sars-cov-2, thrombosis, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 0302 clinical medicine, law, 80 and over, Coronary Artery Disease/epidemiology, Odds Ratio, SARS-cov-2, 030212 general & internal medicine, Prospective Studies, Aged, 80 and over, Thromboembolism/epidemiology, biology, Hazard ratio, Middle Aged, Mortality/trends, Intensive care unit, Thrombosis, Venous thrombosis, Intensive Care Units, C-Reactive Protein, Emergency Medicine, Cardiology, COVID-19/complications, Female, medicine.medical_specialty, Fibrin Fibrinogen Degradation Products/analysis, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, C-Reactive Protein/analysis, Internal medicine, Thromboembolism, Internal Medicine, medicine, Humans, Mortality, Aged, Proportional Hazards Models, Intensive Care Units/organization & administration, business.industry, C-reactive protein, COVID-19, Odds ratio, medicine.disease, Im - Original, Logistic Models, Heart failure, biology.protein, business
Abstract

Background Patients with coronavirus disease 2019 (Covid-19) may experience venous thrombosis while data regarding arterial thrombosis are sparse. Methods Prospective multicenter study in 5 hospitals including 373 patients with Covid-19-related pneumonia. Demographic data, laboratory findings including coagulation tests and comorbidities were reported. During the follow-up any arterial or venous thrombotic events and death were registered. Results Among 373 patients, 75 (20%) had a thrombotic event and 75 (20%) died. Thrombotic events included 41 venous thromboembolism and 34 arterial thrombosis. Age, cardiovascular disease, intensive care unit treatment, white blood cells, D-dimer, albumin and troponin blood levels were associated with thrombotic events. In a multivariable regression logistic model, intensive care unit treatment (Odds Ratio [OR]: 6.0; 95% Confidence Interval [CI] 2.8–12.6; p p = 0.022); and albumin levels (OR: 0.49; 95% CI 0.28–0.87; p = 0.014) were associated with ischemic events. Age, sex, chronic obstructive pulmonary disease, diabetes, heart failure, coronary heart disease, intensive care unit treatment, in-hospital thrombotic events, D-dimer, C-reactive protein, troponin, and albumin levels were associated with mortality. A multivariable Cox regression analysis showed that in-hospital thrombotic events (hazard ratio [HR]: 2.72; 95% CI 1.59–4.65; p p = 0.001), and albumin (HR: 0.447; 95% CI 0.277–0.723; p = 0.001) predicted morality. Conclusions Covid-19 patients experience an equipollent rate of venous and arterial thrombotic events, that are associated with poor survival. Early identification and appropriate treatment of Covid-19 patients at risk of thrombosis may improve prognosis.

Published
2021
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8. Cardiometabolic multimorbidity is associated with a worse Covid-19 prognosis than individual cardiometabolic risk factors: a multicentre retrospective study (CoViDiab II)

Author

Maddaloni, E., D'Onofrio, L., Alessandri, F., Mignogna, C., Leto, G., Pascarella, G., Mezzaroma, I., Lichtner, M., Pozzilli, P., Agro, F. E., Rocco, M., Pugliese, F., Lenzi, A., Holman, R. R., Mastroianni, C. M., Buzzetti, R., Ajassa, C., Alban, R., Alessi, F., Aronica, R., Belvisi, V., Candy, M., Caputi, A., Carrara, A., Casali, E., Cavallari, E. N., Ceccarelli, G., Celani, L., Ciardi, M. R., Coraggio, L., Curtolo, A., D'Agostino, C., D'Ettorre, G., De Giorgi, F., De Girolamo, G., Filippi, V., Gnessi, L., Luordi, C., Moretti, C., Recchia, G., Ridolfi, M., Romani, F. E., Russo, G., Ruberto, F., Savelloni, G., Siccardi, G., Siena, A., Sterpetti, S., Valeri, S., Vera, M., Volpicelli, L., Watanabe, M., Aiuti, M., Campagna, G., Del Borgo, C., Fondaco, L., Kertusha, B., Leonetti, F., Marocco, R., Masala, R., Zuccala, P., Nonnis, G., Rigoli, A., Strumia, A., and Alampi, D.

Subjects
lcsh:Diseases of the circulatory (Cardiovascular) system, medicine.medical_specialty, multimorbidity, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Pneumonia, Viral, pandemics, Logistic regression, metabolic diseases, law.invention, coronavirus infections, male, law, Diabetes mellitus, Internal medicine, middle aged, medicine, 80 and over, copd, covid-19, diabetes, hypertension, sars-cov-2, aged, cardiovascular diseases, diabetes mellitus, female, follow-up studies, humans, pneumonia, viral, prognosis, retrospective studies, risk factors, betacoronavirus, COPD, Original Investigation, Aged, 80 and over, Mechanical ventilation, business.industry, SARS-CoV-2, Confounding, Diabetes, Retrospective cohort study, Odds ratio, medicine.disease, Intensive care unit, lcsh:RC666-701, Hypertension, Cardiology and Cardiovascular Medicine, business, Covid-19
Abstract

Background Cardiometabolic disorders may worsen Covid-19 outcomes. We investigated features and Covid-19 outcomes for patients with or without diabetes, and with or without cardiometabolic multimorbidity. Methods We collected and compared data retrospectively from patients hospitalized for Covid-19 with and without diabetes, and with and without cardiometabolic multimorbidity (defined as ≥ two of three risk factors of diabetes, hypertension or dyslipidaemia). Multivariate logistic regression was used to assess the risk of the primary composite outcome (any of mechanical ventilation, admission to an intensive care unit [ICU] or death) in patients with diabetes and in those with cardiometabolic multimorbidity, adjusting for confounders. Results Of 354 patients enrolled, those with diabetes (n = 81), compared with those without diabetes (n = 273), had characteristics associated with the primary composite outcome that included older age, higher prevalence of hypertension and chronic obstructive pulmonary disease (COPD), higher levels of inflammatory markers and a lower PaO2/FIO2 ratio. The risk of the primary composite outcome in the 277 patients who completed the study as of May 15th, 2020, was higher in those with diabetes (Adjusted Odds Ratio (adjOR) 2.04, 95%CI 1.12–3.73, p = 0.020), hypertension (adjOR 2.31, 95%CI: 1.37–3.92, p = 0.002) and COPD (adjOR 2.67, 95%CI 1.23–5.80, p = 0.013). Patients with cardiometabolic multimorbidity were at higher risk compared to patients with no cardiometabolic conditions (adjOR 3.19 95%CI 1.61–6.34, p = 0.001). The risk for patients with a single cardiometabolic risk factor did not differ with that for patients with no cardiometabolic risk factors (adjOR 1.66, 0.90–3.06, adjp = 0.10). Conclusions Patients with diabetes hospitalized for Covid-19 present with high-risk features. They are at increased risk of adverse outcomes, likely because diabetes clusters with other cardiometabolic conditions.

Published
2020

24. Investigations on Protein Nonenzymatic Glycation by a New and Effective Mass Spectrometric Method

Author

Traldi, P., Lapolla, A., Seraglia, R., Catinella, S., D'alpaos, M., Aronica, R., and Fedele, D.

Abstract

Protein nonenzymatic glyco-oxidation has been studied eitherin vitroorin vivoby matrix assisted laser desorption/ionization (MALDI). Bovine serum albumin and ribonuclease have been incubated in pseudophysiological conditions with different sugar (glucose or fructose) concentrations. Mass increases of incubated proteins have been determined by MALDI and related to different numbers of sugar molecules condensed on the active sites of the protein. The kinetics of glyco-oxidation has been determined for the various sugar concentrations showing in all cases the reaching of a steady-state, corresponding to the complete saturation of the reactive sites. The same methodology has been applied in the study of human serum albumin from healthy subjects and well-controlled and badly controlled diabetic patients. Also in this case, clear differences have been evidenced among the three groups of subjects under investigation. In the case of badly controlled patients, the molecular weight of human serum albumin shows increases with respect to genuine human serum albumin, in the range 439–2403, corresponding to the condensation on that protein from 3 to 15 glucose units.

Published
1996
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27. Digital Mental Health for Schizophrenia and Other Severe Mental Illnesses: An International Consensus on Current Challenges and Potential Solutions.

Author

Smith KA, Hardy A, Vinnikova A, Blease C, Milligan L, Hidalgo-Mazzei D, Lambe S, Marzano L, Uhlhaas PJ, Ostinelli EG, Anmella G, Zangani C, Aronica R, Dwyer B, Torous J, and Cipriani A

Subjects
Humans, Telemedicine ethics, Telemedicine methods, Mental Health Services organization & administration, Mental Disorders therapy, Schizophrenia therapy, Consensus
Abstract

Background: Digital approaches may be helpful in augmenting care to address unmet mental health needs, particularly for schizophrenia and severe mental illness (SMI)., Objective: An international multidisciplinary group was convened to reach a consensus on the challenges and potential solutions regarding collecting data, delivering treatment, and the ethical challenges in digital mental health approaches for schizophrenia and SMI., Methods: The consensus development panel method was used, with an in-person meeting of 2 groups: the expert group and the panel. Membership was multidisciplinary including those with lived experience, with equal participation at all stages and coproduction of the consensus outputs and summary. Relevant literature was shared in advance of the meeting, and a systematic search of the recent literature on digital mental health interventions for schizophrenia and psychosis was completed to ensure that the panel was informed before the meeting with the expert group., Results: Four broad areas of challenge and proposed solutions were identified: (1) user involvement for real coproduction; (2) new approaches to methodology in digital mental health, including agreed standards, data sharing, measuring harms, prevention strategies, and mechanistic research; (3) regulation and funding issues; and (4) implementation in real-world settings (including multidisciplinary collaboration, training, augmenting existing service provision, and social and population-focused approaches). Examples are provided with more detail on human-centered research design, lived experience perspectives, and biomedical ethics in digital mental health approaches for SMI., Conclusions: The group agreed by consensus on a number of recommendations: (1) a new and improved approach to digital mental health research (with agreed reporting standards, data sharing, and shared protocols), (2) equal emphasis on social and population research as well as biological and psychological approaches, (3) meaningful collaborations across varied disciplines that have previously not worked closely together, (4) increased focus on the business model and product with planning and new funding structures across the whole development pathway, (5) increased focus and reporting on ethical issues and potential harms, and (6) organizational changes to allow for true communication and coproduction with those with lived experience of SMI. This study approach, combining an international expert meeting with patient and public involvement and engagement throughout the process, consensus methodology, discussion, and publication, is a helpful way to identify directions for future research and clinical implementation in rapidly evolving areas and can be combined with measurements of real-world clinical impact over time. Similar initiatives will be helpful in other areas of digital mental health and similarly fast-evolving fields to focus research and organizational change and effect improved real-world clinical implementation., (©Katharine A Smith, Amy Hardy, Anastasia Vinnikova, Charlotte Blease, Lea Milligan, Diego Hidalgo-Mazzei, Sinéad Lambe, Lisa Marzano, Peter J Uhlhaas, Edoardo G Ostinelli, Gerard Anmella, Caroline Zangani, Rosario Aronica, Bridget Dwyer, John Torous, Andrea Cipriani. Originally published in JMIR Mental Health (https://mental.jmir.org), 08.05.2024.)

Published
2024
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28. Digital health interventions for schizophrenia: Setting standards for mental health.

Author

Torous J, Smith KA, Hardy A, Vinnikova A, Blease C, Milligan L, Hidalgo-Mazzei D, Lambe S, Marzano L, Uhlhaas PJ, Ostinelli EG, Anmella G, Zangani C, Aronica R, Dwyer B, and Cipriani A

Subjects
Humans, Digital Health, Schizophrenia therapy, Telemedicine standards
Abstract

Competing Interests: Declaration of competing interest KAS, AH, CZ, RA and LM have no conflicts of interest to declare. AC has received research and consultancy fees from INCiPiT (Italian Network for Pediatric Trials), CARIPLO Foundation, Lundbeck, and Angelini Pharma, outside the submitted work. EGO has received research and consultancy fees from Angelini Pharma outside the submitted work. PJU has received honoraria from Boehringer Ingelheim and research funding from Lundbeck and Lilly UK. SL has received consultancy fees from OxfordVR, a University of Oxford spin-out company, which is commercialising the gameChange treatment. JT is co-founder of a mental wellness company called Precision Mental Wellness.

Published
2024
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29. A machine learning approach on whole blood immunomarkers to identify an inflammation-associated psychosis onset subgroup.

Author

Enrico P, Delvecchio G, Turtulici N, Aronica R, Pigoni A, Squarcina L, Villa FM, Perlini C, Rossetti MG, Bellani M, Lasalvia A, Bonetto C, Scocco P, D'Agostino A, Torresani S, Imbesi M, Bellini F, Veronese A, Bocchio-Chiavetto L, Gennarelli M, Balestrieri M, Colombo GI, Finardi A, Ruggeri M, Furlan R, and Brambilla P

Subjects
Humans, Inflammation, Biomarkers, Machine Learning, Brain metabolism, Psychotic Disorders pathology
Abstract

Psychosis onset is a transdiagnostic event that leads to a range of psychiatric disorders, which are currently diagnosed through clinical observation. The integration of multimodal biological data could reveal different subtypes of psychosis onset to target for the personalization of care. In this study, we tested the existence of subgroups of patients affected by first-episode psychosis (FEP) with a possible immunopathogenic basis. To do this, we designed a data-driven unsupervised machine learning model to cluster a sample of 127 FEP patients and 117 healthy controls (HC), based on the peripheral blood expression levels of 12 psychosis-related immune gene transcripts. To validate the model, we applied a resampling strategy based on the half-splitting of the total sample with random allocation of the cases. Further, we performed a post-hoc univariate analysis to verify the clinical, cognitive, and structural brain correlates of the subgroups identified. The model identified and validated two distinct clusters: 1) a FEP cluster characterized by the high expression of inflammatory and immune-activating genes (IL1B, CCR7, IL12A and CXCR3); 2) a cluster consisting of an equal number of FEP and HC subjects, which did not show a relative over or under expression of any immune marker (balanced subgroup). None of the subgroups was related to specific symptoms dimensions or longitudinal diagnosis of affective vs non-affective psychosis. FEP patients included in the balanced immune subgroup showed a thinning of the left supramarginal and superiorfrontal cortex (FDR-adjusted p-values < 0.05). Our results demonstrated the existence of a FEP patients' subgroup identified by a multivariate pattern of immunomarkers involved in inflammatory activation. This evidence may pave the way to sample stratification in clinical studies aiming to develop diagnostic tools and therapies targeting specific immunopathogenic pathways of psychosis., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)

Published
2023
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30. Association between Diffusion Tensor Imaging, inflammation and immunological alterations in unipolar and bipolar depression: A review.

Author

Aronica R, Enrico P, Squarcina L, Brambilla P, and Delvecchio G

Subjects
Humans, Diffusion Tensor Imaging methods, Inflammation pathology, Bipolar Disorder pathology, Depressive Disorder, Major diagnostic imaging, Depressive Disorder, Major pathology, White Matter pathology
Abstract

Major Depressive Disorder (MDD) and Bipolar Disorder Depression (BDD) are common psychiatric illnesses characterized by structural and functional brain alterations and signs of neuroinflammation. In line with the neuroinflammatory pathogenesis of depressive syndromes, recent studies have demonstrated how white matter (WM) microstructural impairments detected by Diffusion Tensor Imaging, are correlated to peripheral immunomarkers in depressed patients. In this context, we performed a comprehensive systematic search on PubMed, Medline and Scopus of the original studies published till June 2022, exploring the association between immunomarkers and WM alteration patterns in patients affected by MDD or BDD. Overall, the studies included in this review showed a consistent association between blood proinflammatory and counter-regulatory immunomarkers, including regulatory T cells and natural killer cells markers, as well as measures of demyelination and dysmyelination in both MDD and BDD patients. These pathogenetic insights could outline an integrated clinical perspective to affective disorders, helping psychiatrists to develop novel biotype-to-phenotype models of depression and opening the way to tailored approaches in treatments., Competing Interests: Competing interests None., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Published
2022
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31. Real-life use of remdesivir-containing regimens in COVID-19: a retrospective case-control study.

Author

Cogliati Dezza F, Oliva A, Mauro V, Romani FE, Aronica R, Savelloni G, Casali E, Valeri S, Cancelli F, and Mastroianni CM

Abstract

Background: Remdesivir (REM) has shown potent antiviral activity in vitro and efficacy in animal models of COVID-19; nevertheless, clinical trials and real-life reports have shown conflicting data on its effectiveness. Aims of the study were to evaluate the impact of remdesivir on I) Intensive Care Unit (ICU) admission, II) need for orotracheal intubation (OTI) and III) in-hospital mortality. Furthermore, we estimated the kinetics of laboratory parameters and assessed the risk factors for in-hospital mortality in the remdesivir population., Methods: We conducted a retrospective, single-center, case-control (1:1) study including hospitalized patients with confirmed SARS-CoV-2 infection. Cases were patients treated with remdesivir for 5 days, controls were patients not receiving remdesivir., Results: A total of 192 patients (96 cases and 96 controls) were included in the study. Patients receiving remdesivir had a lower rate of ICU admission and need for OTI than controls, whereas no difference between cases and controls were observed as for mortality rate. However, at multivariable analysis remdesivir was not associated with ICU admission neither with OTI. Instead, presence of haematological malignancies, lower duration of symptoms, higher severity of infection and low lymphocytes count at admission were independently associated with in-hospital mortality. In patients treated with remdesivir a low albumin value and duration of lymphopenia were significantly associated with mortality., Conclusions: Our real-life study showed that therapy with remdesivir did not have impact on either ICU admission, need for OTI or in-hospital mortality., Competing Interests: Conflict of interest The authors declare that there are no conflicts of interest., (Copyright © 2016 - 2022 InfezMed.)

Published
2022
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32. Comparison of Thrombotic Events and Mortality in Patients with Community-Acquired Pneumonia and COVID-19: A Multicenter Observational Study.

Author

Cangemi R, Calvieri C, Falcone M, Cipollone F, Ceccarelli G, Pignatelli P, D'Ardes D, Pirro M, Alessandri F, Lichtner M, D'Ettorre G, Oliva A, Aronica R, Rocco M, Venditti M, Romiti GF, Tiseo G, Taliani G, Menichetti F, Pugliese F, Mastroianni CM, and Violi F

Subjects
Aged, COVID-19 mortality, Cohort Studies, Community-Acquired Infections mortality, Female, Hospitalization, Humans, Italy epidemiology, Male, Middle Aged, Pneumonia mortality, Risk Factors, Survival Analysis, Thrombosis mortality, COVID-19 epidemiology, Community-Acquired Infections epidemiology, Pneumonia epidemiology, SARS-CoV-2 physiology, Thrombosis epidemiology
Abstract

Background: It is still unclear if patients with community-acquired pneumonia (CAP) and coronavirus disease 2019 (COVID-19) have different rate, typology, and impact of thrombosis on survival., Methods: In this multicenter observational cohort study, 1,138 patients, hospitalized for CAP ( n  = 559) or COVID-19 ( n  = 579) from seven clinical centers in Italy, were included in the study. Consecutive adult patients (age ≥ 18 years) with confirmed COVID-19-related pneumonia, with or without mechanical ventilation, hospitalized from March 1, 2020 to April 30, 2020, were enrolled. COVID-19 was diagnosed based on the World Health Organization interim guidance. Patients were followed-up until discharge or in-hospital death, registering the occurrence of thrombotic events including ischemic/embolic events., Results: During the in-hospital stay, 11.4% of CAP and 15.5% of COVID-19 patients experienced thrombotic events ( p  = 0.046). In CAP patients all the events were arterial thromboses, while in COVID-19 patients 8.3% were venous and 7.2% arterial thromboses.During the in-hospital follow-up, 3% of CAP patients and 17% of COVID-19 patients died ( p  < 0.001). The highest mortality rate was found among COVID-19 patients with thrombotic events (47.6 vs. 13.4% in thrombotic-event-free patients; p  < 0.001). In CAP, 13.8% of patients experiencing thrombotic events died versus 1.8% of thrombotic event-free ones ( p  < 0.001). A multivariable Cox-regression analysis confirmed a higher risk of death in COVID-19 patients with thrombotic events (hazard ratio: 2.1; 95% confidence interval: 1.4-3.3; p  < 0.001)., Conclusion: Compared with CAP, COVID-19 is characterized by a higher burden of thrombotic events, different thrombosis typology and higher risk of thrombosis-related in-hospital mortality., Competing Interests: None declared., (Thieme. All rights reserved.)

Published
2022
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34. SARS-CoV-2 Among Migrants Recently Arrived in Europe From Low- and Middle-Income Countries: Containment Strategies and Special Features of Management in Reception Centers.

Author

Fabris S, d'Ettorre G, Spagnolello O, Russo A, Lopalco M, D'Agostino F, Vassalini P, Celani L, Aronica R, Gabrielli S, d'Ettorre G, Angeletti S, Mastroianni CM, Ciccozzi M, and Ceccarelli G

Subjects
Developing Countries, Europe, Humans, SARS-CoV-2, COVID-19, Transients and Migrants
Abstract

Despite the "migrants and COVID-19" topic has been neglected since felt marginal concerning other aspects of the SARS-CoV-2 pandemic, it represents a relevant public health issue in the European countries. This report describes COVID-19 containment strategies adopted in a large Italian reception center hosting recently arrived asylum-seeker migrants. Risk assessment and prevention measures adopted were described. Geo-spatial epidemiological analysis of the outbreak was reported. Significant gaps in the knowledge of self-protection measures from contagious diseases and in the perception of the pandemic risk were observed in migrants; health promotion activities, targeted to remove cultural barriers and improve behaviors appropriate to individual protection, were able to fulfill this gap. In low-resource settings, especially in closed communities, the implementation of social distancing strategies, the systematic use of individual protection devices, and active syndromic surveillance are essential tools to limit the risk of outbreaks. In the event of an outbreak, it is relevant to rapidly activate containment procedures based on systematic screening, isolation, and quarantine, taking into consideration the limits of tracing contacts within a closed community. Not being able to trace certain contacts, the geo-spatial epidemiological analysis of cases distribution could be key in the management of the outbreak. Interestingly, positive cases identified in our facility were all clinically pauci-symptomatic or asymptomatic. Dedicated strategies are needed to minimize the chance of SARS-CoV-2 transmission in a limited space such as reception centers and a vulnerable population such as migrants., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Fabris, d'Ettorre, Spagnolello, Russo, Lopalco, D'Agostino, Vassalini, Celani, Aronica, Gabrielli, d'Ettorre, Angeletti, Mastroianni, Ciccozzi and Ceccarelli.)

Published
2021
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35. Role of Serum E-Selectin as a Biomarker of Infection Severity in Coronavirus Disease 2019.

Author

Oliva A, Rando E, Al Ismail D, De Angelis M, Cancelli F, Miele MC, Aronica R, Mauro V, Di Timoteo F, Loffredo L, and Mastroianni CM

Abstract

Introduction: E-selectin is a recognized marker of endothelial activation; however, its place in Coronavirus Disease 2019 (COVID-19) has not been fully explored. Aims of the study are to compare sE-selectin values among the Intensive Care Unit (ICU)-admitted and non-admitted, survived and non-survived patients and those with or without thrombosis., Methods: A single-center study of patients with COVID-19 hospitalized at Policlinico Umberto I (Rome) from March to May 2020 was performed. Simple and multiple logistic regression models were developed., Results: One hundred patients were included, with a median age (IQR) of 65 years (58-78). Twenty-nine (29%) were admitted to ICU, twenty-eight (28%) died and nineteen (19%) had a thrombotic event. The median value (IQR) of sE-selectin was 26.1 ng/mL (18.1-35). sE-selectin values did not differ between deceased and survivors ( p = 0.06) and among patients with or without a thrombotic event ( p = 0.22). Compared with patients who did not receive ICU treatments, patients requiring ICU care had higher levels of sE-selectin (36.6 vs. 24.1 ng/mL; p < 0.001). In the multiple logistic regression model, sE-selectin levels > 33 ng/mL, PaO 2 /FiO 2 < 200 and PaO 2 /FiO 2 200-300 were significantly associated with an increased risk of ICU admission. sE-selectin values significantly correlated with a neutrophil count (R = 0.32 ( p = 0.001)) and the number of days from the symptoms onset to hospitalization (R = 0.28 ( p = 0.004))., Conclusions: sE-selectin levels are predictive of ICU admission in COVID-19 patients. Since data on the relation between sE-selectin and COVID-19 are scarce, this study aims to contribute toward the comprehension of the pathogenic aspects of COVID-19 disease, giving a possible clinical marker able to predict its severity.

Published
2021
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36. Candida fracture-related infection: a systematic review.

Author

De Meo D, Cera G, Ceccarelli G, Castagna V, Aronica R, Pieracci EM, Persiani P, and Villani C

Abstract

Background : The aim of this study is to summarize and improve knowledge regarding a Candida fracture-related infection (CFRI) through a systematic review on the topic, accompanied by a case report. Methods : A systematic review and meta-analysis based on PRISMA statement were conducted on the CFRI topic. The following combined search terms were used to explore PubMed, Cochrane, and the Embase database: "fungal infection", "candida", "fracture related infection", "bone infection", "orthopedic infection", "internal fixation", "post-traumatic infection", and "osteomyelitis". Results : Out of 1514 records, only 5 case reports matched the selection criteria and were included. Moreover, a new case of CFRI, not previously described, was reported in this paper and reviewed. The main risk factors for CFRI were open wounds (three cases) and immunodeficiency (three cases). Initial improvement of clinical and laboratory signs of infection was noted in all cases. In the available short-term follow-up (mean 12.1 months; range 3-42), the reoperation rate was 33.3 %. Using a strategy based on extensive debridement/resection methods and prolonged systemic antifungal therapy (mean 8.8 weeks; range 6-18), four of six cases (66.6 %) were cured. Bone union occurred in three out of six cases. Conclusion : There is very low-quality evidence available regarding CFRI. Candida infections in surgically treated fractures are rare but difficult-to-treat events, with a slow onset, unspecific symptoms or signs, and a significant relapse risk; therefore, they still represent a current diagnostic challenge. The existing fracture-related infection treatment algorithm combined with long-term systemic antifungal therapy has an anecdotal value and needs more extensive studies to be validated., Competing Interests: The authors declare that they have no conflict of interest., (Copyright: © 2021 Daniele De Meo et al.)

Published
2021
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37. Persistent Systemic Microbial Translocation and Intestinal Damage During Coronavirus Disease-19.

Author

Oliva A, Miele MC, Di Timoteo F, De Angelis M, Mauro V, Aronica R, Al Ismail D, Ceccarelli G, Pinacchio C, d'Ettorre G, Mascellino MT, and Mastroianni CM

Subjects
Acute-Phase Proteins metabolism, Aged, Biomarkers metabolism, COVID-19 diagnosis, COVID-19 mortality, COVID-19 pathology, Carrier Proteins metabolism, Disease Progression, Fatty Acid-Binding Proteins metabolism, Female, Humans, Intensive Care Units, Intestinal Mucosa pathology, Male, Membrane Glycoproteins metabolism, Middle Aged, Predictive Value of Tests, Prognosis, Survival Analysis, Tight Junctions metabolism, COVID-19 metabolism, Intestinal Mucosa metabolism, SARS-CoV-2 physiology
Abstract

Microbial translocation (MT) and intestinal damage (ID) are poorly explored in COVID-19. Aims were to assess whether alteration of gut permeability and cell integrity characterize COVID-19 patients, whether it is more pronounced in severe infections and whether it influences the development of subsequent bloodstream infection (BSI). Furthermore, we looked at the potential predictive role of TM and ID markers on Intensive Care Unit (ICU) admission and in-hospital mortality. Over March-July 2020, 45 COVID-19 patients were enrolled. Markers of MT [LPB (Lipopolysacharide Binding Protein) and EndoCab IgM] and ID [I-FABP (Intestinal Fatty Acid Binding Protein)] were evaluated at COVID-19 diagnosis and after 7 days. As a control group, age- and gender-matched healthy donors (HDs) enrolled during the same study period were included. Median age was 66 (56-71) years. Twenty-one (46.6%) were admitted to ICU and mortality was 22% (10/45). Compared to HD, a high degree of MT and ID was observed. ICU patients had higher levels of MT, but not of ID, than non-ICU ones. Likewise, patients with BSI had lower EndoCab IgM than non-BSI. Interestingly, patients with high degree of MT and low ID were likely to be admitted to ICU (AUC 0.822). Patients with COVID-19 exhibited high level of MT, especially subjects admitted to ICU. COVID-19 is associated with gut permeability., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Oliva, Miele, Di Timoteo, De Angelis, Mauro, Aronica, Al Ismail, Ceccarelli, Pinacchio, d’Ettorre, Mascellino and Mastroianni.)

Published
2021
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38. Migrants rescued on the Mediterranean Sea route: nutritional, psychological status and infectious disease control.

Author

Angeletti S, Ceccarelli G, Bazzardi R, Fogolari M, Vita S, Antonelli F, De Florio L, Khazrai YM, De Noia V, Lopalco M, Alagia D, Pedone C, Lauri G, Aronica R, Riva E, Demir AB, Abacioglu H, and Ciccozzi M

Subjects
Child, Communicable Disease Control methods, Communicable Diseases epidemiology, Eritrea, Europe epidemiology, Female, Humans, Libya, Male, Malnutrition epidemiology, Mass Screening, Mediterranean Sea, Refugees statistics & numerical data, Rescue Work, Transients and Migrants statistics & numerical data, Communicable Disease Control statistics & numerical data, Malnutrition etiology, Refugees psychology, Transients and Migrants psychology
Abstract

Introduction: North Africa has become a key migratory hub where a large number of migrants attempt the journey by sea from the Libyan coastline to the south of Europe. In this humanitarian disaster scenario, the Mediterranean route has been one of the most used by illegal boats., Methodology: In this report, the state of physical and psychological health of a cluster of Eritrean migrants, escaped from Libya and rescued in the Mediterranean Sea after a shipwreck, was described by epidemiological, clinical and laboratory investigations., Results: Data suggest that despite the majority  of the migrants being apparently in good health upon a syndromic surveillance approach, most of them suffered a decline in psychological status as well as severe malnutrition. The emergence of infectious diseases, related to poor living conditions during the journey, is not a rare event., Conclusion: The present report highlights the risks of failures of the syndromic medical approach in the setting of the extremely challenging migration route and underlines migrant frailties consequent to a prolonged journey and long period of detention. These stressors, which can degrade the initial health condition of traveling migrants, can lead to a premature "exhausted migrant effect" that should be carefully investigated in order to avoid the early emergence of diseases related to frailty., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2020 Silvia Angeletti, Giancarlo Ceccarelli, Riccardo Bazzardi, Marta Fogolari, Serena Vita, Francesca Antonelli, Lucia De Florio, Yeganeh Manon Khazrai, Vincenza De Noia, Maurizio Lopalco, Domenico Alagia, Claudio Pedone, Gaetano Lauri, Rosario Aronica, Elisabetta Riva, Ayse Banu Demir, Hakan Abacioglu, Massimo Ciccozzi.)

Published
2020
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40. Evaluation of IgG glycation levels by matrix-assisted laser desorption/ionization mass spectrometry.

Author

Lapolla A, Fedele D, Aronica R, Garbeglio M, D'Alpaos M, Seraglia R, and Traldi P

Subjects
Aged, Blood Glucose metabolism, Diabetes Mellitus, Type 2 blood, Glucose chemistry, Glucose metabolism, Humans, Middle Aged, Serum Albumin chemistry, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, Spectrophotometry, Ultraviolet, Immunoglobulin G chemistry
Abstract

Matrix-assisted laser desorption/ionization (MALDI) mass spectrometry has been employed for the evaluation of the glycation level of IgG from healthy subjects and also from well- and badly-controlled diabetic patients. The measurements have been performed on untreated plasma protein fractions. The data obtained have shown that a clear mass increase, originating from non-enzymatic glycation processes, is observed in the case of diabetic patients: for well-controlled ones it is in the range 512-1565 Da, while it becomes 827-4270 Da for badly-controlled diabetic patients. This approach indicates that MALDI mass spectrometry is a highly specific tool that can be employed in the metabolic control of diabetic patients and in studies relating the IgG glycation level to possible immunological impairment.

Published
1997
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41. A highly specific method for the characterization of glycation and glyco-oxidation products of globins.

Author

Lapolla A, Fedele D, Aronica R, Garbeglio M, D'Alpaos M, Plebani M, Seraglia R, and Traldi P

Subjects
Adult, Aged, Chromatography, High Pressure Liquid, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 metabolism, Female, Globins isolation & purification, Glycated Hemoglobin analysis, Humans, Male, Middle Aged, Oxidation-Reduction, Reproducibility of Results, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, Globins chemistry, Glucose chemistry
Abstract

A new method, based on matrix-assisted laser desorption/ionization (MALDI) measurements, has been developed for the evaluation of the glycation level of globins, a relevant parameter for diabetes control. It shows high levels of reproducibility and specificity, allowing the different glycated and glyco-oxidized products of both alpha- and beta-globins to be distinguished. Such specificity is reflected in its possible diagnostic use not only for the control of diabetes, but also for the occurrence of 'oxidative stress'. The comparison, for the same samples, of the obtained MALDI data with the related HbA1c values, determined by a high performance liquid chromatographic method, allowed it to be established that HbA1c percentages are not, as usually retained, related to the simply glycated beta-globin, but to the whole pool of glycated and glyco-oxidized alpha- and beta-globins.

Published
1997
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42. The in vivo glyco-oxidation of alpha- and beta-globins investigated by matrix-assisted laser desorption/ionization mass spectrometry.

Author

Lapolla A, Fedele D, Aronica R, Garbeglio M, D'Alpaos M, Seraglia R, and Traldi P

Subjects
Diabetes Mellitus blood, Glucose chemistry, Glycoproteins chemistry, Hemoglobins chemistry, Humans, In Vitro Techniques, Middle Aged, Molecular Weight, Oxidation-Reduction, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, Globins chemistry
Abstract

Matrix-assisted laser desorption/ionization (MALDI) has been employed for the determination of molecular weights of alpha- and beta-globins obtained from blood samples of healthy and diabetic subjects. Glycated species, originating from the reaction of glucose with the proteins, are easily evident. The MALDI measurements allowed one to distinguish between simple glycation and glyco-oxidation processes of haemoglobin. In fact, together with the products arising from simple glucose condensation on the two proteins, compounds at different oxidation levels were evident. Due to its high specificity, MALDI must be considered a valuable tool for diagnosis in the diabetes field.

Published
1996
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43. An electrospray investigation on in vitro glycation of ribonuclease.

Author

Lapolla A, Fedele D, Baldo L, Aronica R, Raverdino V, Catinella S, Seraglia R, and Traldi P

Subjects
Amino Acid Sequence, Animals, Cattle, Glucose chemistry, Glucose metabolism, Mass Spectrometry, Molecular Sequence Data, Protein Structure, Secondary, Ribonucleases chemistry, Ribonucleases metabolism
Abstract

The in vitro reactions of RNase with different concentrations of glucose or fructose have been studied by means of electrospray mass spectrometry coupled with microcolumn high performance liquid chromatography. The results obtained have shown that, subsequent to the protein glycation, a series of cross-linking products are generated. Their molecular weights demonstrate that severe degradation processes of the proteic substrate takes place after the cross-linking process.

Published
1996
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44. The in vitro glycation of lysozyme and the influence of buffer concentration investigated by mass spectrometry.

Author

Lapolla A, Fedele D, Aronica R, Baldo L, D'Alpaos M, Seraglia R, and Traldi P

Subjects
Buffers, Cross-Linking Reagents, Fructose chemistry, Phosphates chemistry, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, Glucose chemistry, Muramidase chemistry
Abstract

The non-enzymatic reactions between glucose or fructose with lysozyme, performed under pseudo-physiological conditions, have been studied by means of matrix-assisted laser desorption/ionization mass spectrometry. Phosphate buffer at concentrations of 0.05, 0.2 and 0.5 M has been employed. The formation of glycated proteins as well as of cross-linking products has been always observed. In the case of glucose, high phosphate buffer concentrations affect the glycation kinetics and promote the formation of cross-linking products. With fructose, such influence is moderate, the reaction kinetics being mainly influenced by the higher reactivity of the sugar.

Published
1996
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