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3. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.

Author

Axfors C., Janiaud P., Schmitt A.M., van't Hooft J., Smith E.R., Haber N.A., Abayomi A., Abduljalil M., Abdulrahman A., Acosta-Ampudia Y., Aguilar-Guisado M., Al-Beidh F., Alejandria M.M., Alfonso R.N., Ali M., AlQahtani M., AlZamrooni A., Anaya J.-M., Ang M.A.C., Aomar I.F., Argumanis L.E., Averyanov A., Baklaushev V.P., Balionis O., Benfield T., Berry S., Birocco N., Bonifacio L.B., Bowen A.C., Bown A., Cabello-Gutierrez C., Camacho B., Camacho-Ortiz A., Campbell-Lee S., Cao D.H., Cardesa A., Carnate J.M., Castillo G.J.J., Cavallo R., Chowdhury F.R., Chowdhury F.U.H., Ciccone G., Cingolani A., Climacosa F.M.M., Compernolle V., Cortez C.F.N., Costa Neto A., D'Antico S., Daly J., Danielle F., Davis J.S., De Rosa F.G., Denholm J.T., Denkinger C.M., Desmecht D., Diaz-Coronado J.C., Diaz Ponce-Medrano J.A., Donneau A.-F., Dumagay T.E., Dunachie S., Dungog C.C., Erinoso O., Escasa I.M.S., Estcourt L.J., Evans A., Evasan A.L.M., Fareli C.J., Fernandez-Sanchez V., Galassi C., Gallo J.E., Garcia P.J., Garcia P.L., Garcia J.A., Garigliany M., Garza-Gonzalez E., Gauiran D.T.V., Gaviria Garcia P.A., Giron-Gonzalez J.-A., Gomez-Almaguer D., Gordon A.C., Gothot A., Grass Guaqueta J.S., Green C., Grimaldi D., Hammond N.E., Harvala H., Heralde F.M., Herrick J., Higgins A.M., Hills T.E., Hines J., Holm K., Hoque A., Hoste E., Ignacio J.M., Ivanov A.V., Janssen M., Jennings J.H., Jha V., King R.A.N., Kjeldsen-Kragh J., Klenerman P., Kotecha A., Krapp F., Labanca L., Laing E., Landin-Olsson M., Laterre P.-F., Lim L.-L., Lim J., Ljungquist O., Llaca-Diaz J.M., Lopez-Robles C., Lopez-Cardenas S., Lopez-Plaza I., Lucero J.A.C., Lundgren M., Macias J., Maganito S.C., Malundo A.F.G., Manrique R.D., Manzini P.M., Marcos M., Marquez I., Martinez-Marcos F.J., Mata A.M., McArthur C.J., McQuilten Z.K., McVerry B.J., Menon D.K., Meyfroidt G., Mirasol M.A.L., Misset B., Molton J.S., Mondragon A.V., Monsalve D.M., Moradi Choghakabodi P., Morpeth S.C., Mouncey P.R., Moutschen M., Muller-Tidow C., Murphy E., Najdovski T., Nichol A.D., Nielsen H., Novak R.M., O'Sullivan M.V.N., Olalla J., Osibogun A., Osikomaiya B., Oyonarte S., Pardo-Oviedo J.M., Patel M.C., Paterson D.L., Pena-Perez C.A., Perez-Calatayud A.A., Perez-Alba E., Perkina A., Perry N., Pouladzadeh M., Poyato I., Price D.J., Quero A.K.H., Rahman M.M., Rahman M.S., Ramesh M., Ramirez-Santana C., Rasmussen M., Rees M.A., Rego E., Roberts J.A., Roberts D.J., Rodriguez Y., Rodriguez-Bano J., Rogers B.A., Rojas M., Romero A., Rowan K.M., Saccona F., Safdarian M., Santos M.C.M., Sasadeusz J., Scozzari G., Shankar-Hari M., Sharma G., Snelling T., Soto A., Tagayuna P.Y., Tang A., Tatem G., Teofili L., Tong S.Y.C., Turgeon A.F., Veloso J.D., Venkatesh B., Ventura-Enriquez Y., Webb S.A., Wiese L., Wiken C., Wood E.M., Yusubalieva G.M., Zacharowski K., Zarychanski R., Khanna N., Moher D., Goodman S.N., Ioannidis J.P.A., Hemkens L.G., Axfors C., Janiaud P., Schmitt A.M., van't Hooft J., Smith E.R., Haber N.A., Abayomi A., Abduljalil M., Abdulrahman A., Acosta-Ampudia Y., Aguilar-Guisado M., Al-Beidh F., Alejandria M.M., Alfonso R.N., Ali M., AlQahtani M., AlZamrooni A., Anaya J.-M., Ang M.A.C., Aomar I.F., Argumanis L.E., Averyanov A., Baklaushev V.P., Balionis O., Benfield T., Berry S., Birocco N., Bonifacio L.B., Bowen A.C., Bown A., Cabello-Gutierrez C., Camacho B., Camacho-Ortiz A., Campbell-Lee S., Cao D.H., Cardesa A., Carnate J.M., Castillo G.J.J., Cavallo R., Chowdhury F.R., Chowdhury F.U.H., Ciccone G., Cingolani A., Climacosa F.M.M., Compernolle V., Cortez C.F.N., Costa Neto A., D'Antico S., Daly J., Danielle F., Davis J.S., De Rosa F.G., Denholm J.T., Denkinger C.M., Desmecht D., Diaz-Coronado J.C., Diaz Ponce-Medrano J.A., Donneau A.-F., Dumagay T.E., Dunachie S., Dungog C.C., Erinoso O., Escasa I.M.S., Estcourt L.J., Evans A., Evasan A.L.M., Fareli C.J., Fernandez-Sanchez V., Galassi C., Gallo J.E., Garcia P.J., Garcia P.L., Garcia J.A., Garigliany M., Garza-Gonzalez E., Gauiran D.T.V., Gaviria Garcia P.A., Giron-Gonzalez J.-A., Gomez-Almaguer D., Gordon A.C., Gothot A., Grass Guaqueta J.S., Green C., Grimaldi D., Hammond N.E., Harvala H., Heralde F.M., Herrick J., Higgins A.M., Hills T.E., Hines J., Holm K., Hoque A., Hoste E., Ignacio J.M., Ivanov A.V., Janssen M., Jennings J.H., Jha V., King R.A.N., Kjeldsen-Kragh J., Klenerman P., Kotecha A., Krapp F., Labanca L., Laing E., Landin-Olsson M., Laterre P.-F., Lim L.-L., Lim J., Ljungquist O., Llaca-Diaz J.M., Lopez-Robles C., Lopez-Cardenas S., Lopez-Plaza I., Lucero J.A.C., Lundgren M., Macias J., Maganito S.C., Malundo A.F.G., Manrique R.D., Manzini P.M., Marcos M., Marquez I., Martinez-Marcos F.J., Mata A.M., McArthur C.J., McQuilten Z.K., McVerry B.J., Menon D.K., Meyfroidt G., Mirasol M.A.L., Misset B., Molton J.S., Mondragon A.V., Monsalve D.M., Moradi Choghakabodi P., Morpeth S.C., Mouncey P.R., Moutschen M., Muller-Tidow C., Murphy E., Najdovski T., Nichol A.D., Nielsen H., Novak R.M., O'Sullivan M.V.N., Olalla J., Osibogun A., Osikomaiya B., Oyonarte S., Pardo-Oviedo J.M., Patel M.C., Paterson D.L., Pena-Perez C.A., Perez-Calatayud A.A., Perez-Alba E., Perkina A., Perry N., Pouladzadeh M., Poyato I., Price D.J., Quero A.K.H., Rahman M.M., Rahman M.S., Ramesh M., Ramirez-Santana C., Rasmussen M., Rees M.A., Rego E., Roberts J.A., Roberts D.J., Rodriguez Y., Rodriguez-Bano J., Rogers B.A., Rojas M., Romero A., Rowan K.M., Saccona F., Safdarian M., Santos M.C.M., Sasadeusz J., Scozzari G., Shankar-Hari M., Sharma G., Snelling T., Soto A., Tagayuna P.Y., Tang A., Tatem G., Teofili L., Tong S.Y.C., Turgeon A.F., Veloso J.D., Venkatesh B., Ventura-Enriquez Y., Webb S.A., Wiese L., Wiken C., Wood E.M., Yusubalieva G.M., Zacharowski K., Zarychanski R., Khanna N., Moher D., Goodman S.N., Ioannidis J.P.A., and Hemkens L.G.

Abstract

Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Method(s): In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Result(s): A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3

Published
2021

4. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, C, Janiaud, P, Schmitt, AM, Van't Hooft, J, Smith, ER, Haber, NA, Abayomi, A, Abduljalil, M, Abdulrahman, A, Acosta-Ampudia, Y, Aguilar-Guisado, M, Al-Beidh, F, Alejandria, MM, Alfonso, RN, Ali, M, AlQahtani, M, AlZamrooni, A, Anaya, J-M, Ang, MAC, Aomar, IF, Argumanis, LE, Averyanov, A, Baklaushev, VP, Balionis, O, Benfield, T, Berry, S, Birocco, N, Bonifacio, LB, Bowen, AC, Bown, A, Cabello-Gutierrez, C, Camacho, B, Camacho-Ortiz, A, Campbell-Lee, S, Cao, DH, Cardesa, A, Carnate, JM, Castillo, GJJ, Cavallo, R, Chowdhury, FR, Chowdhury, FUH, Ciccone, G, Cingolani, A, Climacosa, FMM, Compernolle, V, Cortez, CFN, Neto, AC, D'Antico, S, Daly, J, Danielle, F, Davis, JS, De Rosa, FG, Denholm, JT, Denkinger, CM, Desmecht, D, Diaz-Coronado, JC, Diaz Ponce-Medrano, JA, Donneau, A-F, Dumagay, TE, Dunachie, S, Dungog, CC, Erinoso, O, Escasa, IMS, Estcourt, LJ, Evans, A, Evasan, ALM, Fareli, CJ, Fernandez-Sanchez, V, Galassi, C, Gallo, JE, Garcia, PJ, Garcia, PL, Garcia, JA, Garigliany, M, Garza-Gonzalez, E, Gauiran, DT, Gaviria Garcia, PA, Giron-Gonzalez, J-A, Gomez-Almaguer, D, Gordon, AC, Gothot, A, Grass Guaqueta, JS, Green, C, Grimaldi, D, Hammond, NE, Harvala, H, Heralde, FM, Herrick, J, Higgins, AM, Hills, TE, Hines, J, Holm, K, Hoque, A, Hoste, E, Ignacio, JM, Ivanov, A, Janssen, M, Jennings, JH, Jha, V, King, RAN, Kjeldsen-Kragh, J, Klenerman, P, Kotecha, A, Krapp, F, Labanca, L, Laing, E, Landin-Olsson, M, Laterre, P-F, Lim, L-L, Lim, J, Ljungquist, O, Llaca-Diaz, JM, Lopez-Robles, C, Lopez-Cardenas, S, Lopez-Plaza, I, Lucero, JAC, Lundgren, M, Macias, J, Maganito, SC, Malundo, AFG, Manrique, RD, Manzini, PM, Marcos, M, Marquez, I, Javier Martinez-Marcos, F, Mata, AM, McArthur, CJ, McQuilten, ZK, McVerry, BJ, Menon, DK, Meyfroidt, G, Mirasol, MAL, Misset, B, Molton, JS, Mondragon, A, Monsalve, DM, Choghakabodi, PM, Morpeth, SC, Mouncey, PR, Moutschen, M, Muller-Tidow, C, Murphy, E, Najdovski, T, Nichol, AD, Nielsen, H, Novak, RM, O'Sullivan, MVN, Olalla, J, Osibogun, A, Osikomaiya, B, Oyonarte, S, Pardo-Oviedo, JM, Patel, MC, Paterson, DL, Pena-Perez, CA, Perez-Calatayud, AA, Perez-Alba, E, Perkina, A, Perry, N, Pouladzadeh, M, Poyato, I, Price, DJ, Quero, AKH, Rahman, MM, Rahman, MS, Ramesh, M, Ramirez-Santana, C, Rasmussen, M, Rees, MA, Rego, E, Roberts, JA, Roberts, DJ, Rodriguez, Y, Rodriguez-Bano, J, Rogers, BA, Rojas, M, Romero, A, Rowan, KM, Saccona, F, Safdarian, M, Santos, MCM, Sasadeusz, J, Scozzari, G, Shankar-Hari, M, Sharma, G, Snelling, T, Soto, A, Tagayuna, PY, Tang, A, Tatem, G, Teofili, L, Tong, SYC, Turgeon, AF, Veloso, JD, Venkatesh, B, Ventura-Enriquez, Y, Webb, SA, Wiese, L, Wiken, C, Wood, EM, Yusubalieva, GM, Zacharowski, K, Zarychanski, R, Khanna, N, Moher, D, Goodman, SN, Ioannidis, JPA, Hemkens, LG, Axfors, C, Janiaud, P, Schmitt, AM, Van't Hooft, J, Smith, ER, Haber, NA, Abayomi, A, Abduljalil, M, Abdulrahman, A, Acosta-Ampudia, Y, Aguilar-Guisado, M, Al-Beidh, F, Alejandria, MM, Alfonso, RN, Ali, M, AlQahtani, M, AlZamrooni, A, Anaya, J-M, Ang, MAC, Aomar, IF, Argumanis, LE, Averyanov, A, Baklaushev, VP, Balionis, O, Benfield, T, Berry, S, Birocco, N, Bonifacio, LB, Bowen, AC, Bown, A, Cabello-Gutierrez, C, Camacho, B, Camacho-Ortiz, A, Campbell-Lee, S, Cao, DH, Cardesa, A, Carnate, JM, Castillo, GJJ, Cavallo, R, Chowdhury, FR, Chowdhury, FUH, Ciccone, G, Cingolani, A, Climacosa, FMM, Compernolle, V, Cortez, CFN, Neto, AC, D'Antico, S, Daly, J, Danielle, F, Davis, JS, De Rosa, FG, Denholm, JT, Denkinger, CM, Desmecht, D, Diaz-Coronado, JC, Diaz Ponce-Medrano, JA, Donneau, A-F, Dumagay, TE, Dunachie, S, Dungog, CC, Erinoso, O, Escasa, IMS, Estcourt, LJ, Evans, A, Evasan, ALM, Fareli, CJ, Fernandez-Sanchez, V, Galassi, C, Gallo, JE, Garcia, PJ, Garcia, PL, Garcia, JA, Garigliany, M, Garza-Gonzalez, E, Gauiran, DT, Gaviria Garcia, PA, Giron-Gonzalez, J-A, Gomez-Almaguer, D, Gordon, AC, Gothot, A, Grass Guaqueta, JS, Green, C, Grimaldi, D, Hammond, NE, Harvala, H, Heralde, FM, Herrick, J, Higgins, AM, Hills, TE, Hines, J, Holm, K, Hoque, A, Hoste, E, Ignacio, JM, Ivanov, A, Janssen, M, Jennings, JH, Jha, V, King, RAN, Kjeldsen-Kragh, J, Klenerman, P, Kotecha, A, Krapp, F, Labanca, L, Laing, E, Landin-Olsson, M, Laterre, P-F, Lim, L-L, Lim, J, Ljungquist, O, Llaca-Diaz, JM, Lopez-Robles, C, Lopez-Cardenas, S, Lopez-Plaza, I, Lucero, JAC, Lundgren, M, Macias, J, Maganito, SC, Malundo, AFG, Manrique, RD, Manzini, PM, Marcos, M, Marquez, I, Javier Martinez-Marcos, F, Mata, AM, McArthur, CJ, McQuilten, ZK, McVerry, BJ, Menon, DK, Meyfroidt, G, Mirasol, MAL, Misset, B, Molton, JS, Mondragon, A, Monsalve, DM, Choghakabodi, PM, Morpeth, SC, Mouncey, PR, Moutschen, M, Muller-Tidow, C, Murphy, E, Najdovski, T, Nichol, AD, Nielsen, H, Novak, RM, O'Sullivan, MVN, Olalla, J, Osibogun, A, Osikomaiya, B, Oyonarte, S, Pardo-Oviedo, JM, Patel, MC, Paterson, DL, Pena-Perez, CA, Perez-Calatayud, AA, Perez-Alba, E, Perkina, A, Perry, N, Pouladzadeh, M, Poyato, I, Price, DJ, Quero, AKH, Rahman, MM, Rahman, MS, Ramesh, M, Ramirez-Santana, C, Rasmussen, M, Rees, MA, Rego, E, Roberts, JA, Roberts, DJ, Rodriguez, Y, Rodriguez-Bano, J, Rogers, BA, Rojas, M, Romero, A, Rowan, KM, Saccona, F, Safdarian, M, Santos, MCM, Sasadeusz, J, Scozzari, G, Shankar-Hari, M, Sharma, G, Snelling, T, Soto, A, Tagayuna, PY, Tang, A, Tatem, G, Teofili, L, Tong, SYC, Turgeon, AF, Veloso, JD, Venkatesh, B, Ventura-Enriquez, Y, Webb, SA, Wiese, L, Wiken, C, Wood, EM, Yusubalieva, GM, Zacharowski, K, Zarychanski, R, Khanna, N, Moher, D, Goodman, SN, Ioannidis, JPA, and Hemkens, LG

Abstract

BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% o

Published
2021

5. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, C., Janiaud, P., Schmitt, A. M., van't Hooft, J., Smith, E. R., Haber, N. A., Abayomi, A., Abduljalil, M., Abdulrahman, A., Acosta-Ampudia, Y., Aguilar-Guisado, M., Al-Beidh, F., Alejandria, M. M., Alfonso, R. N., Ali, M., Alqahtani, M., Alzamrooni, A., Anaya, J. -M., Ang, M. A. C., Aomar, I. F., Argumanis, L. E., Averyanov, A., Baklaushev, V. P., Balionis, O., Benfield, T., Berry, S., Birocco, N., Bonifacio, L. B., Bowen, A. C., Bown, A., Cabello-Gutierrez, C., Camacho, B., Camacho-Ortiz, A., Campbell-Lee, S., Cao, D. H., Cardesa, A., Carnate, J. M., Castillo, G. J. J., Cavallo, R., Chowdhury, F. R., Chowdhury, F. U. H., Ciccone, G., Cingolani, Antonella, Climacosa, F. M. M., Compernolle, V., Cortez, C. F. N., Costa Neto, A., D'Antico, S., Daly, J., Danielle, F., Davis, J. S., De Rosa, F. G., Denholm, J. T., Denkinger, C. M., Desmecht, D., Diaz-Coronado, J. C., Diaz Ponce-Medrano, J. A., Donneau, A. -F., Dumagay, T. E., Dunachie, S., Dungog, C. C., Erinoso, O., Escasa, I. M. S., Estcourt, L. J., Evans, A., Evasan, A. L. M., Fareli, C. J., Fernandez-Sanchez, V., Galassi, C., Gallo, J. E., Garcia, P. J., Garcia, P. L., Garcia, J. A., Garigliany, M., Garza-Gonzalez, E., Gauiran, D. T. V., Gaviria Garcia, P. A., Giron-Gonzalez, J. -A., Gomez-Almaguer, D., Gordon, A. C., Gothot, A., Grass Guaqueta, J. S., Green, C., Grimaldi, D., Hammond, N. E., Harvala, H., Heralde, F. M., Herrick, J., Higgins, A. M., Hills, T. E., Hines, J., Holm, K., Hoque, A., Hoste, E., Ignacio, J. M., Ivanov, A. V., Janssen, M., Jennings, J. H., Jha, V., King, R. A. N., Kjeldsen-Kragh, J., Klenerman, P., Kotecha, A., Krapp, F., Labanca, L., Laing, E., Landin-Olsson, M., Laterre, P. -F., Lim, L. -L., Lim, J., Ljungquist, O., Llaca-Diaz, J. M., Lopez-Robles, C., Lopez-Cardenas, S., Lopez-Plaza, I., Lucero, J. A. C., Lundgren, M., Macias, J., Maganito, S. C., Malundo, A. F. G., Manrique, R. D., Manzini, P. M., Marcos, M., Marquez, I., Martinez-Marcos, F. J., Mata, A. M., Mcarthur, C. J., Mcquilten, Z. K., Mcverry, B. J., Menon, D. K., Meyfroidt, G., Mirasol, M. A. L., Misset, B., Molton, J. S., Mondragon, A. V., Monsalve, D. M., Moradi Choghakabodi, P., Morpeth, S. C., Mouncey, P. R., Moutschen, M., Muller-Tidow, C., Murphy, E., Najdovski, T., Nichol, A. D., Nielsen, H., Novak, R. M., O'Sullivan, M. V. N., Olalla, J., Osibogun, A., Osikomaiya, B., Oyonarte, S., Pardo-Oviedo, J. M., Patel, M. C., Paterson, D. L., Pena-Perez, C. A., Perez-Calatayud, A. A., Perez-Alba, E., Perkina, A., Perry, N., Pouladzadeh, M., Poyato, I., Price, D. J., Quero, A. K. H., Rahman, M. M., Rahman, M. S., Ramesh, M., Ramirez-Santana, C., Rasmussen, M., Rees, M. A., Rego, E., Roberts, J. A., Roberts, D. J., Rodriguez, Y., Rodriguez-Bano, J., Rogers, B. A., Rojas, M., Romero, A., Rowan, K. M., Saccona, F., Safdarian, M., Santos, M. C. M., Sasadeusz, J., Scozzari, G., Shankar-Hari, M., Sharma, G., Snelling, T., Soto, A., Tagayuna, P. Y., Tang, A., Tatem, G., Teofili, Luciana, Tong, S. Y. C., Turgeon, A. F., Veloso, J. D., Venkatesh, B., Ventura-Enriquez, Y., Webb, S. A., Wiese, L., Wiken, C., Wood, E. M., Yusubalieva, G. M., Zacharowski, K., Zarychanski, R., Khanna, N., Moher, D., Goodman, S. N., Ioannidis, J. P. A., Hemkens, L. G., Cingolani A. (ORCID:0000-0002-3793-2755), Teofili L. (ORCID:0000-0002-7214-1561), Axfors, C., Janiaud, P., Schmitt, A. M., van't Hooft, J., Smith, E. R., Haber, N. A., Abayomi, A., Abduljalil, M., Abdulrahman, A., Acosta-Ampudia, Y., Aguilar-Guisado, M., Al-Beidh, F., Alejandria, M. M., Alfonso, R. N., Ali, M., Alqahtani, M., Alzamrooni, A., Anaya, J. -M., Ang, M. A. C., Aomar, I. F., Argumanis, L. E., Averyanov, A., Baklaushev, V. P., Balionis, O., Benfield, T., Berry, S., Birocco, N., Bonifacio, L. B., Bowen, A. C., Bown, A., Cabello-Gutierrez, C., Camacho, B., Camacho-Ortiz, A., Campbell-Lee, S., Cao, D. H., Cardesa, A., Carnate, J. M., Castillo, G. J. J., Cavallo, R., Chowdhury, F. R., Chowdhury, F. U. H., Ciccone, G., Cingolani, Antonella, Climacosa, F. M. M., Compernolle, V., Cortez, C. F. N., Costa Neto, A., D'Antico, S., Daly, J., Danielle, F., Davis, J. S., De Rosa, F. G., Denholm, J. T., Denkinger, C. M., Desmecht, D., Diaz-Coronado, J. C., Diaz Ponce-Medrano, J. A., Donneau, A. -F., Dumagay, T. E., Dunachie, S., Dungog, C. C., Erinoso, O., Escasa, I. M. S., Estcourt, L. J., Evans, A., Evasan, A. L. M., Fareli, C. J., Fernandez-Sanchez, V., Galassi, C., Gallo, J. E., Garcia, P. J., Garcia, P. L., Garcia, J. A., Garigliany, M., Garza-Gonzalez, E., Gauiran, D. T. V., Gaviria Garcia, P. A., Giron-Gonzalez, J. -A., Gomez-Almaguer, D., Gordon, A. C., Gothot, A., Grass Guaqueta, J. S., Green, C., Grimaldi, D., Hammond, N. E., Harvala, H., Heralde, F. M., Herrick, J., Higgins, A. M., Hills, T. E., Hines, J., Holm, K., Hoque, A., Hoste, E., Ignacio, J. M., Ivanov, A. V., Janssen, M., Jennings, J. H., Jha, V., King, R. A. N., Kjeldsen-Kragh, J., Klenerman, P., Kotecha, A., Krapp, F., Labanca, L., Laing, E., Landin-Olsson, M., Laterre, P. -F., Lim, L. -L., Lim, J., Ljungquist, O., Llaca-Diaz, J. M., Lopez-Robles, C., Lopez-Cardenas, S., Lopez-Plaza, I., Lucero, J. A. C., Lundgren, M., Macias, J., Maganito, S. C., Malundo, A. F. G., Manrique, R. D., Manzini, P. M., Marcos, M., Marquez, I., Martinez-Marcos, F. J., Mata, A. M., Mcarthur, C. J., Mcquilten, Z. K., Mcverry, B. J., Menon, D. K., Meyfroidt, G., Mirasol, M. A. L., Misset, B., Molton, J. S., Mondragon, A. V., Monsalve, D. M., Moradi Choghakabodi, P., Morpeth, S. C., Mouncey, P. R., Moutschen, M., Muller-Tidow, C., Murphy, E., Najdovski, T., Nichol, A. D., Nielsen, H., Novak, R. M., O'Sullivan, M. V. N., Olalla, J., Osibogun, A., Osikomaiya, B., Oyonarte, S., Pardo-Oviedo, J. M., Patel, M. C., Paterson, D. L., Pena-Perez, C. A., Perez-Calatayud, A. A., Perez-Alba, E., Perkina, A., Perry, N., Pouladzadeh, M., Poyato, I., Price, D. J., Quero, A. K. H., Rahman, M. M., Rahman, M. S., Ramesh, M., Ramirez-Santana, C., Rasmussen, M., Rees, M. A., Rego, E., Roberts, J. A., Roberts, D. J., Rodriguez, Y., Rodriguez-Bano, J., Rogers, B. A., Rojas, M., Romero, A., Rowan, K. M., Saccona, F., Safdarian, M., Santos, M. C. M., Sasadeusz, J., Scozzari, G., Shankar-Hari, M., Sharma, G., Snelling, T., Soto, A., Tagayuna, P. Y., Tang, A., Tatem, G., Teofili, Luciana, Tong, S. Y. C., Turgeon, A. F., Veloso, J. D., Venkatesh, B., Ventura-Enriquez, Y., Webb, S. A., Wiese, L., Wiken, C., Wood, E. M., Yusubalieva, G. M., Zacharowski, K., Zarychanski, R., Khanna, N., Moher, D., Goodman, S. N., Ioannidis, J. P. A., Hemkens, L. G., Cingolani A. (ORCID:0000-0002-3793-2755), and Teofili L. (ORCID:0000-0002-7214-1561)

Abstract

Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of

Published
2021

10. Patient blood management knowledge and practice among clinicians from seven European university hospitals: amulticentre survey

Author

Manzini, P.M., Dall'Omo, A.M., D'Antico, S., Valfre, A., Pendry, K., Wikman, A., Pampus, E.C.M. van, Kraaij, M.G.J. van, Bruun, M.T., Follea, G., Aranko, K., Manzini, P.M., Dall'Omo, A.M., D'Antico, S., Valfre, A., Pendry, K., Wikman, A., Pampus, E.C.M. van, Kraaij, M.G.J. van, Bruun, M.T., Follea, G., and Aranko, K.

Abstract

Item does not contain fulltext

Published
2018

11. Patient blood management knowledge and practice among clinicians from seven European university hospitals: a multicentre survey

Author

Manzini, P. M., primary, Dall'Omo, A. M., additional, D'Antico, S., additional, Valfrè, A., additional, Pendry, K., additional, Wikman, A., additional, Fischer, D., additional, Borg-Aquilina, D., additional, Laspina, S., additional, van Pampus, E. C. M., additional, van Kraaij, M., additional, Bruun, M. T., additional, Georgsen, J., additional, Grant-Casey, J., additional, Babra, P. S., additional, Murphy, M. F., additional, Folléa, G., additional, and Aranko, K., additional

Published
2017
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12. ANOIKIS AND APOPTOTIC VOLUME DECREASE IN ISOLATED RAT DISTAL COLON SURFACE CELLS

Author

Antico, S, GIORDANO, Maria Elena, LIONETTO, Maria Giulia, SCHETTINO, Trifone, Antico, S, Giordano, Maria Elena, Lionetto, Maria Giulia, and Schettino, Trifone

Subjects
apoptotic volume decrease, colon, cell volume reulation, Anoiki
Abstract

Apoptosis is a physiological form of death that is crucial in growth, maintenance and normal development of tissues. One of the first events in apoptosis is the isotonic shrinkage of the cells, named Apoptotic Volume Decrease (AVD). The aim of the present work was to address the possible link between anoikis (apoptosis induced by detachment from the extracellular matrix) and cell volume changes that characterize the onset of apoptosis in isolated superficial rat colonocytes. Cell suspension was obtained by incubating the everted colon in 0.5% trypsin solution in Dulbecco's Modified Eagle Medium at 30 °C for about 1 h. Cell viability after preparation was tested by Trypan blue exclusion test. Since one of the earliest indications of apoptosis is the translocation of the membrane phospholipid phosphatidylserine from the inner to the outer leaflet of the plasma membrane, the detection of apoptosis was performed by annexin V and propidium iodide labeling and confocal microscopy; cell volume changes were monitored by light microscopy and video imaging. The results obtained in the present work demonstrated that colonocytes underwent anoikis within a few hours after isolation, as indicated by the appearance of annexin V positivity. During the first phase of apoptosis the cells showed an early normotonic shrinkage, increasing with the time. This phenomenon can be ascribed to AVD, representing one of the major hallmark of apoptosis.

Published
2012

14. Study of the actin cytoskeleton in rat colon exposed to osmotic stress by confocal microscopy

Author

GIORDANO, Maria Elena, LIONETTO, Maria Giulia, SCHETTINO, Trifone, Antico, S., Giordano, Maria Elena, Lionetto, Maria Giulia, Antico, S., and Schettino, Trifone

Subjects
colon, osmotic stre, cytoskeleton, confocal microscopy, actin
Abstract

Among the many sensors and transducers involved in cell volume regulation, the cytoskeleton plays an important role activating a series of cascading events that bear the cell to the original hydration state. The aims of the present work are the characterization of the F-actin cytoskeleton in rat colonocytes by confocal microscopy and the evaluation of possible F-actin rearrangements following exposure of the tissue to hypotonic and hypertonic stress. The study was carried out on paraformaldehyde fixed colon criosections stained with rhodamine-phalloidin. In rat colonocytes actin is mainly localized along the peripheral part of the cell defining the cortical cytoskeleton, with greater rhodamin staining in the brush-border region. In hypertonic stress condition the cortical cytoskeleton showed a significant constriction after 5 minutes of stress exposure, as indicated by the decrease of cytockeleton perimenter, followed by a Regulatory Volume Increase (RVI) response after 30 minutes of stress exposure. In hypotonic conditions the cortical cytosckeleton showed an expansion, followed by a Regulatory Volume Decrease (RVD) response which reported the cells to the initial size. The results suggest that the changes undergone by the cytoskeleton in the course of the osmotic shrinkage and swelling represents a "sensor" of the cell volume changes. Therefore, F-actin skeleton, associated with ion membrane transporters, would play a crucial role in the RVI and RVD activation in rat colon.

Published
2012

18. Synergistic effect of erythromycin on polymorphonuclear cell antibacterial activity against erythromycin-resistant phenotypes of Streptococcus pyogenes.[*A.M.Cuffini is the corresponding author]

Author

Banche, Giuliana, Tullio, Viviana Cristina, Allizond, Valeria, Mandras, Narcisa, Roana, Janira, Scalas, Daniela, El Fassi, F, D'Antico, S, Cuffini, Annamaria, and Carlone, Nicola

Subjects
Phagocytic killing, Phagocytosis, Streptococcus pyogenes, Polymorphonuclear cells, Erythromycin
Published
2010

29. Screening selected blood donors with biochemical iron overload for hemochromatosis: a regional experience

Author

Bondi, A., Camaschella, C., Castagno, F., D Antico, S., Marco De Gobbi, Merlini, R., and Testa, D.

Subjects
Adult, Male, Questionnaires, Iron Overload, Alcohol Drinking, Genotype, analysis, etiology, Iron, DNA Mutational Analysis, Mutation, Missense, Blood Donors, complications/diagnosis/epidemiology, blood, Surveys and Questionnaires, Humans, Mass Screening, Point Mutation, genetics, Hemochromatosis Protein, Histocompatibility Antigens Class I, Transferrin, Membrane Proteins, Middle Aged, Adult, Alcohol Drinking, epidemiology, Amino Acid Substitution, Blood Donors, DNA Mutational Analysis, Female, Ferritins, analysis, Genotype, Hemochromatosis, complications/diagnosis/epidemiology, Histocompatibility Antigens Class I, genetics, Humans, Iron Overload, etiology, Iron, blood, Italy, epidemiology, Male, Mass Screening, Membrane Proteins, genetics, Middle Aged, Mutation, Missense, Phenotype, Point Mutation, Questionnaires, Transferrin, Phenotype, Amino Acid Substitution, Italy, Ferritins, Mutation, epidemiology, Female, Hemochromatosis, Missense
Abstract

Hemochromatosis is a genetic disorder characterized by progressive iron overload which leads to early abnormalities of iron parameters (increased transferrin saturation =TS and serum ferritin=SF) and late clinical complications. The disease is prevalently due to C282Y and H63D mutations in the HFE gene, but additional molecular defects are present in a minority of patients.From January to December 2002 we screened first time blood donors of Piedmont, a region of North-western Italy, for TS45%. Individuals with TS45% underwent a second fasting check, SF assessment and molecular tests, investigating 12 hemochromatosis-associated molecular defects.A total of 13,998 subjects were screened; 868 (6.2%) had TS45% and were recalled. Four hundred and eight-six underwent molecular testing. In this selected population allele frequencies of C282Y, H63D and S65C were 6.8%, 22.4% and 1.0%, respectively. No rare mutations were detected, except E168Q in HFE. When measured during fasting, TS was significantly higher in C282Y homozygotes and H63D/C282Y heterozygotes (p0.05) than in wild type subjects, but not in H63D homozygotes. Hyperferritinemia was documented in 32 cases, 9 with wild type genotype. Mean age, body mass index (BMI) and alcohol intake were higher in this group than in individuals with normal SF.This study is an example of a large, two-step hemochromatosis screening with moderate effort and low cost, that enriches basal C282Y allele frequency by about three-fold. Screening based on genotyping only subjects found to have a TS45% is feasible but, in order to be cost effective should be based on the identification of the two prevalent mutations even in an area where several forms of hemochromatosis have been reported.

Published
2004

30. Impact of age in phenotype of thiopurine methyltransferase

Author

Calvo, P.L., primary, Canaparo, R., additional, Baldi, M., additional, Serpe, L., additional, Giaccone, M., additional, Lerro, P., additional, Muntoni, E., additional, D’Antico, S., additional, Vinciguerra, T., additional, Eandi, M., additional, Zara, G.P., additional, and Barbera, C., additional

Published
2008
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36. The use of laser-nephelometry in evaluating fibrinogenaemia in patients with hepatocarcinoma and cirrhosis

Author

Girolami, A., Antico, S., Vittorio Pengo, Ruffato, G., Callegari, F., and Cappellato, M.

Subjects
Liver Cirrhosis, Kinetics, Carcinoma, Hepatocellular, Nephelometry and Turbidimetry, Lasers, Liver Neoplasms, Fibrinogen, Humans
Abstract

In the present study fibrinogen was assayed by the immunonephelometric method in 19 patients afflicted with hepatocarcinoma and 24 patients afflicted with cirrhosis. The two groups were similar in age, sex and presence of HbsAg. The incidence of values above the norm was significantly greater in patients with hepatocarcinoma (p less than 0.05). Then, the concentration of fibrinogen was measured in all using two other immunological methods (Laurell and Mancini) and two coagulative methods (Clauss and Ratnoff). A dysfibrinogenemia (an excess of fibrinogen assayed by immunological methods to be greater than 100 mg/dl with respect to biological methods). is more frequent using the Nephelometer-Clauss (p less than 0.01) and Mancini-Clauss (p less than 0.01) methods in patients with hepatocarcinoma with respect to those with cirrhosis. The study of the kinetics of antifibrinogen antigen-antibody reaction failed to show differences between patients with hepatocarcinoma or cirrhosis and normal subjects.

38. Can Thorough Cleaning of Endoscopes Prevent Transmission of Hepatitis C Virus Infection?

Author

Ciancio, A., Manzini, P., Castagno, F., D'Antico, S., Reynaudo, P., Coucourde, L., Ciccone, G., del Piano, M., Ballarë, M., Peyre, S., Rizzi, R., Barletti, C., Bruno, M., Caronna, S., Carucci, P., de Bernardi Venon, W., de Angelis, C., Morgando, A., Musso, A., and Repici, A.

Subjects
HEPATITIS C virus, ENDOSCOPY, GENERAL practitioners, LIVER diseases, VIRAL hepatitis, VIRUS diseases
Abstract

The article presents information on transmission of Hepatitis C virus infection. Endoscopy is a method of examining the inside of a patient's digestive tract. It involves inserting a flexible, illuminated tube through the mouth or anus, allowing the doctor to examine, biopsy, and sometimes treat diseases of the digestive tract. Endoscopy often produces a small amount of bleeding, particularly if biopsies are performed. None of the initially uninfected patients who underwent endoscopy had acquired HCV infection at the time of follow-up. It made no difference whether biopsies were performed or whether disposable or reusable forceps had been used.

Published
2005
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39. Platelet rich plasma for primary macular hole: A case series.

Author

Parisi G, Gelormini F, Ricardi F, Borrelli E, Parisi F, Belluardo G, Azzaro L, Marolo P, D'antico S, Salafia M, and Reibaldi M

Subjects
Humans, Female, Male, Retrospective Studies, Aged, Middle Aged, Follow-Up Studies, Endotamponade, Treatment Outcome, Retinal Perforations surgery, Retinal Perforations diagnosis, Visual Acuity physiology, Tomography, Optical Coherence, Vitrectomy, Platelet-Rich Plasma
Abstract

Objective: To evaluate the anatomical and functional macular results and rate of complications following surgical treatment of primary macular hole (MH) with autologous platelet rich plasma (a-PRP) use., Design: retrospective, interventional, non-randomized case series., Partecipants and Methods: A cohort of 9 consecutive patients from January 1, 2019 to August 31, 2021 who underwent vitrectomy with a-PRP use for primary MH were included. Anatomical results based on spectral domain- optical coherence tomography (SD-OCT) and visual acuity were analyzed., Results: 10 pseudophakic eye of 9 patients were enrolled. Six patients were female and three patients were male. The mean age was 69.9 years ± 1.48. The baseline MH minimum diameter was 486.1 μm ± 37.1, and mean pre operative best-corrected visual acuity (BCVA) was 0.91 ± 0.03 logMAR (Snellen equivalent 20/160). Mean 1 month post operative BCVA was 0.81 ± 0.57 logMAR (Snellen equivalent 20/130; p  = 1.000); mean 3 month post operative BCVA was 0.66 ± 0.04 logMAR (Snellen equivalent 20/90; p  = 0.006); mean 6 month post operative BCVA was 0.6 ± 0.04 logMAR (Snellen equivalent 20/80; p  < 0.001). In all eyes, 10/10 (100%), there was a complete MH closure at 6 months follow up: 5 eyes (50%) with a U-type closure pattern, 4 eyes (40%) with a V-type pattern and 1 eye (10%) with an irregular foveal contour closure at 6 month follow-up. No ocular and systemic complications were reported., Conclusion: The a-PRP use is a successful and promising vitreoretinal surgical technique option for primary MH., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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40. The no-retina-touch technique: vitrectomy and platelet-rich plasma in the treatment of lamellar macular hole. New insights into pathogenesis.

Author

Ricardi F, Gelormini F, Parisi G, Vallino V, Borrelli E, Marolo P, D'Antico S, Salafia M, and Reibaldi M

Abstract

Purpose: To explore the use of autologous platelet-rich plasma (PRP) as a potential therapeutic adjuvant strategy for treating degenerative lamellar macular holes (LMHs)., Design: A prospective interventional case series., Methods: Seven consecutive patients (8 eyes) with a diagnosis of LMH underwent a pars-plana vitrectomy with PRP injection under air tamponade. Anatomical results based on spectral domain optical coherence tomography (SD-OCT) and functional results, in terms of best corrected visual acuity (BCVA) and reading performance, were analyzed., Results: At 12 months postoperatively, 7 out of 8 eyes (88%) presented a complete closure of the LMH. The ellipsoid zone (EZ) was restored in 3 eyes (37.5%). The mean (±SD) postoperative BCVA was 0.39 (±0.56) LogMAR, resulting in a statistically significant visual acuity improvement (p = 0.007). The mean (±SD) maximum reading speed (MaxRS) improved to 133.48 (±41.47) wpm, with a significant increase compared to the baseline (p = 0.029). The mean (±SD) reading acuity score (RA score) resulted in 0.44 (±0.04) LogRAD, with an improvement in reading acuity that did not reach statistical significance (p = 0.129)., Conclusions: The utilization of the PRP technique with a no-retina-touch approach safeguards the delicate retinal tissues, minimizing the possibility of iatrogenic trauma or post-operative complications, while maintaining a high rate of efficacy in enabling the improvement of the foveal defect in lamellar macular holes., (© 2024. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.)

Published
2024
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41. Platelet concentrates in macular hole surgery. A journey through the labyrinth of terminology, preparation, and application: a comprehensive review.

Author

Gelormini F, D'antico S, Ricardi F, Parisi G, Borrelli E, Marolo P, Conte F, Salafia M, and Reibaldi M

Subjects
Humans, Platelet-Rich Plasma, Blood Platelets, Terminology as Topic, Platelet Transfusion methods, Retinal Perforations surgery, Retinal Perforations diagnosis, Vitrectomy methods
Abstract

The surgical management of macular holes is undergoing continuous evolution, with recent focus on the utilization of platelet concentrates as a promising adjunctive intervention. Currently, they present a valid surgical approach for achieving anatomical and functional success with a non-inferiority comparably to the alternative surgical techniques. Nonetheless, the utilization of varied platelet concentrates terminologies, coupled with the lack of standardization in their preparation methodologies, engenders both lexical confusion and challenges in comparing scientific studies published up until now. In this review, we summarized the published evidence concerning the application of platelet concentrates in macular holes surgery, aiming to clarify the terminology and methodologies employed and to establish a common consensus facilitating further development and diffusion of this promising technique., (© 2024. The Author(s).)

Published
2024
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42. Macula-Off Retinal Detachment with Refractory Macular Hole Previously Closed with Autologous Platelet-Rich Plasma: A Case Report.

Author

Parisi G, Ricardi F, Boscia G, Ghilardi A, Gelormini F, Marolo P, Fallico M, D'Antico S, Salafia M, and Reibaldi M

Abstract

The purpose of this report was to present a case of a refractory full-thickness macular hole (FTMH) complicated with recurrent retinal detachment (RD) previously treated with an autologous platelet-rich plasma (aPRP) plug. A 65-year-old male patient presented to our department with a FTMH, RD, and a giant retinal break. Preoperative best corrected visual acuity (BCVA) was 1.40 logMAR (20/500). A 25-G pars plana vitrectomy (PPV) was performed, with peripheral retinal-breaks laser barrage, peeling of the internal limiting membrane, and silicon oil injection. One month later, spectral domain optical coherence tomography (SD-OCT) showed the persistence of the FTMH with a diameter of 712 μm. Therefore, the patient underwent silicon oil removal and aPRP injection with good anatomical outcome and improvement of BCVA to 0.6 log-MAR (20/80). Two months later a recurrence of macula-off RD was detected, but SD-OCT showed that the aPRP plug was still in place and kept the two margins of the macular hole together. The patient underwent a further PPV with silicon oil injection and subsequent silicon oil removal with no postoperative complications. Two months later, the retina remained attached, SD-OCT confirmed FTMH closure and BCVA was 0.52 logMAR (20/63). In conclusion, this case report aims to underline the remarkable efficacy of aPRP in promoting FTMH closure, which was maintained despite subsequent recurrence of macula-off RD., Competing Interests: All the authors have no conflict of interest to declare., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Published
2023
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43. First pilot case-control interventional study using autologous extracellular vesicles to treat chronic venous ulcers unresponsive to conventional treatments.

Author

Gibello L, D'Antico S, Salafia M, Senetta R, Pomatto MAC, Orlando G, Sarcinella A, Lopatina T, Quaglino P, Lorenzi M, Verzini F, Camussi G, and Brizzi MF

Subjects
Humans, Treatment Outcome, Wound Healing, Varicose Ulcer therapy, Extracellular Vesicles, Vascular Diseases
Abstract

Current therapeutic approaches for chronic venous ulcers (CVUs) still require evidence of effectiveness. Diverse sources of extracellular vesicles (EVs) have been proposed for tissue regeneration, however the lack of potency tests, to predict in-vivo effectiveness, and a reliable scalability have delayed their clinical application. This study aimed to investigate whether autologous serum-derived EVs (s-EVs), recovered from patients with CVUs, may be a proper therapeutic approach to improve the healing process. A pilot case-control interventional study (CS2/1095/0090491) has been designed and s-EVs recovered from patients. Patient eligibility included two or more distinct chronic lesions in the same limb with 11 months as median persistence of active ulcer before enrollment. Patients were treated three times a week, for 2 weeks. Qualitative CVU analysis demonstrated that s-EVs-treated lesions displayed a higher percentage of granulation tissue compared to the control group (Sham) (s-EVs 3 out of 5: 75-100 % vs Sham: none), further confirmed at day 30. s-EVs-treated lesions also displayed higher sloughy tissue reduction at the end of treatment even increased at day 30. Additionally, s-EV treatment led to a median surface reduction of 151 mm 2 compared to 84 mm 2 in the Sham group, difference even more evident at day 30 (s-EVs 385 mm 2 vs Sham 106 mm 2 p = 0.004). Consistent with the enrichment of transforming growth factor-β1 in s-EVs, histological analyses showed a regenerative tissue with an increase in microvascular proliferation areas. This study first demonstrates the clinical effectiveness of autologous s-EVs in promoting the healing process of CVUs unresponsive to conventional treatments., Competing Interests: Conflict of interest G.C. is a component of the Scientific Advisory Board of Unicyte AG. The other authors have no conflicts of interest to declare., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2023
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44. Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial.

Author

Manzini PM, Ciccone G, De Rosa FG, Cavallo R, Ghisetti V, D'Antico S, Galassi C, Saccona F, Castiglione A, Birocco N, Francisci T, Hu H, Pecoraro C, Danielle F, Labanca L, Bordiga AM, Lorenzi M, Camisasca G, Giachino O, Pagliarino M, Ottone P, Scuvera ITD, Guaschino R, Freilone R, Berti P, Pittaluga F, Avolio M, Costa C, Raso S, Nucci A, Milan M, Baffa A, Russo A, Tornello A, Maddalena L, Delios G, Marletto FP, De Micheli AG, Mattei A, Baldassano S, Canta F, Russo ML, Bergamo D, Vitale F, Liccardi MM, Chinaglia A, Calcagno A, Converso M, Aldieri C, Libanore V, Blangetti I, Benedetti V, Mitola B, and Scozzari G

Subjects
Aged, Female, Humans, Male, Plasma, Standard of Care, Middle Aged, COVID-19 Serotherapy, COVID-19 therapy, Respiratory Insufficiency
Abstract

Background: The efficacy of early treatment with convalescent plasma in patients with COVID-19 is debated. Nothing is known about the potential effect of other plasma components other than anti-SARS-CoV-2 antibodies., Methods: To determine whether convalescent or standard plasma would improve outcomes for adults in early phase of Covid19 respiratory impairment we designed this randomized, three-arms, clinical trial (PLACO COVID) blinded on interventional arms that was conducted from June 2020 to August 2021. It was a multicentric trial at 19 Italian hospitals. We enrolled 180 hospitalized adult patients with COVID-19 pneumonia within 5 days from the onset of respiratory distress. Patients were randomly assigned in a 1:1:1 ratio to standard of care (n = 60) or standard of care + three units of standard plasma (n = 60) or standard of care + three units of high-titre convalescent plasma (n = 60) administered on days 1, 3, 5 after randomization. Primary outcome was 30-days mortality. Secondary outcomes were: incidence of mechanical ventilation or death at day 30, 6-month mortality, proportion of days with mechanical ventilation on total length of hospital stay, IgG anti-SARS-CoV-2 seroconversion, viral clearance from plasma and respiratory tract samples, and variations in Sequential Organ Failure Assessment score. The trial was analysed according to the intention-to-treat principle., Results: 180 patients (133/180 [73.9%] males, mean age 66.6 years [IQR 57-73]) were enrolled a median of 8 days from onset of symptoms. At enrollment, 88.9% of patients showed moderate/severe respiratory failure. 30-days mortality was 20% in Control arm, 23% in Convalescent (risk ratio [RR] 1.13; 95% confidence interval [CI], 0.61-2.13, P = 0.694) and 25% in Standard plasma (RR 1.23; 95%CI, 0.63-2.37, P = 0.544). Time to viral clearance from respiratory tract was 21 days for Convalescent, 28 for Standard plasma and 23 in Control arm but differences were not statistically significant. No differences for other secondary endpoints were seen in the three arms. Serious adverse events were reported in 1.7%, 3.3% and 5% of patients in Control, Standard and Convalescent plasma arms respectively., Conclusions: Neither high-titer Convalescent nor Standard plasma improve outcomes of COVID-19 patients with acute respiratory failure. Trial Registration Clinicaltrials.gov Identifier: NCT04428021. First posted: 11/06/2020., (© 2022. The Author(s).)

Published
2022
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45. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.

Author

Axfors C, Janiaud P, Schmitt AM, Van't Hooft J, Smith ER, Haber NA, Abayomi A, Abduljalil M, Abdulrahman A, Acosta-Ampudia Y, Aguilar-Guisado M, Al-Beidh F, Alejandria MM, Alfonso RN, Ali M, AlQahtani M, AlZamrooni A, Anaya JM, Ang MAC, Aomar IF, Argumanis LE, Averyanov A, Baklaushev VP, Balionis O, Benfield T, Berry S, Birocco N, Bonifacio LB, Bowen AC, Bown A, Cabello-Gutierrez C, Camacho B, Camacho-Ortiz A, Campbell-Lee S, Cao DH, Cardesa A, Carnate JM, Castillo GJJ, Cavallo R, Chowdhury FR, Chowdhury FUH, Ciccone G, Cingolani A, Climacosa FMM, Compernolle V, Cortez CFN, Costa Neto A, D'Antico S, Daly J, Danielle F, Davis JS, De Rosa FG, Denholm JT, Denkinger CM, Desmecht D, Díaz-Coronado JC, Díaz Ponce-Medrano JA, Donneau AF, Dumagay TE, Dunachie S, Dungog CC, Erinoso O, Escasa IMS, Estcourt LJ, Evans A, Evasan ALM, Fareli CJ, Fernandez-Sanchez V, Galassi C, Gallo JE, Garcia PJ, Garcia PL, Garcia JA, Garigliany M, Garza-Gonzalez E, Gauiran DTV, Gaviria García PA, Giron-Gonzalez JA, Gómez-Almaguer D, Gordon AC, Gothot A, Grass Guaqueta JS, Green C, Grimaldi D, Hammond NE, Harvala H, Heralde FM, Herrick J, Higgins AM, Hills TE, Hines J, Holm K, Hoque A, Hoste E, Ignacio JM, Ivanov AV, Janssen M, Jennings JH, Jha V, King RAN, Kjeldsen-Kragh J, Klenerman P, Kotecha A, Krapp F, Labanca L, Laing E, Landin-Olsson M, Laterre PF, Lim LL, Lim J, Ljungquist O, Llaca-Díaz JM, López-Robles C, López-Cárdenas S, Lopez-Plaza I, Lucero JAC, Lundgren M, Macías J, Maganito SC, Malundo AFG, Manrique RD, Manzini PM, Marcos M, Marquez I, Martínez-Marcos FJ, Mata AM, McArthur CJ, McQuilten ZK, McVerry BJ, Menon DK, Meyfroidt G, Mirasol MAL, Misset B, Molton JS, Mondragon AV, Monsalve DM, Moradi Choghakabodi P, Morpeth SC, Mouncey PR, Moutschen M, Müller-Tidow C, Murphy E, Najdovski T, Nichol AD, Nielsen H, Novak RM, O'Sullivan MVN, Olalla J, Osibogun A, Osikomaiya B, Oyonarte S, Pardo-Oviedo JM, Patel MC, Paterson DL, Peña-Perez CA, Perez-Calatayud AA, Pérez-Alba E, Perkina A, Perry N, Pouladzadeh M, Poyato I, Price DJ, Quero AKH, Rahman MM, Rahman MS, Ramesh M, Ramírez-Santana C, Rasmussen M, Rees MA, Rego E, Roberts JA, Roberts DJ, Rodríguez Y, Rodríguez-Baño J, Rogers BA, Rojas M, Romero A, Rowan KM, Saccona F, Safdarian M, Santos MCM, Sasadeusz J, Scozzari G, Shankar-Hari M, Sharma G, Snelling T, Soto A, Tagayuna PY, Tang A, Tatem G, Teofili L, Tong SYC, Turgeon AF, Veloso JD, Venkatesh B, Ventura-Enriquez Y, Webb SA, Wiese L, Wikén C, Wood EM, Yusubalieva GM, Zacharowski K, Zarychanski R, Khanna N, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Subjects
Humans, Immunization, Passive, Randomized Controlled Trials as Topic, SARS-CoV-2, Treatment Outcome, COVID-19 Serotherapy, COVID-19 therapy
Abstract

Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX )., Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence., Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I 2  = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis., Conclusions: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care., (© 2021. The Author(s).)

Published
2021
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46. Serum Derived Extracellular Vesicles Mediated Delivery of Synthetic miRNAs in Human Endothelial Cells.

Author

Tapparo M, Pomatto MAC, Deregibus MC, Papadimitriou E, Cavallari C, D'Antico S, Collino F, and Camussi G

Abstract

Extracellular vesicles (EVs) have emerged in the last decades as a cell-to-cell communication mechanism. One of their mechanism of action is the direct delivery of their cargo, composed of bioactive molecules to target cells. Different methods (direct electroporation, cell transfection, chemical transfection) were developed to vehicle therapeutic molecules through EVs. However, most of these techniques presented some limitations such as EV disruption and aggregation. In the present study, we demonstrated that a direct temperature-controlled co-incubation of EVs with defined miRNAs is a stable method to deliver information to target cells without affecting EV constitutive content. We chose serum as an easy and abundant source of EVs applicable to autologous treatment after EV modification. Exogenous cel-miR-39 loaded on serum EVs (SEVs) was taken up by human endothelial cells, demonstrating an adequate miRNA loading efficacy based on the co-incubation method. Moreover, SEVs co-incubation with the angiomiRNA-126 (miR-126) enhanced their angiogenic properties in vitro and in vivo by increasing the capacity to induce capillary-like structure formation of human endothelial cells. MiR-126 loaded EVs were also shown to stimulate mouse endothelial cells to invade Matrigel plugs and create more vessels with respect to the EV naive counterpart. When SEVs were loaded with miR-19b, an anti-angiogenic miRNA, they were able to reduce Vascular endothelial growth factors (VEGF) pro-angiogenic capacity, supporting the selective biological effect mediated by the carried miRNA. Lastly, we identified Annexin A2 (ANXA2) as one of the molecules involved in the exogenous RNA binding to serum EV surface, favoring miRNA delivery to target endothelial cells for potential therapeutic application., Competing Interests: GC is a component of the scientific advisory board of Unicyte AG (Torino, Italy). The remaining 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 Tapparo, Pomatto, Deregibus, Papadimitriou, Cavallari, D’Antico, Collino and Camussi.)

Published
2021
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47. Improved Loading of Plasma-Derived Extracellular Vesicles to Encapsulate Antitumor miRNAs.

Author

Pomatto MAC, Bussolati B, D'Antico S, Ghiotto S, Tetta C, Brizzi MF, and Camussi G

Abstract

Extracellular vesicles (EVs) carry various molecules involved in intercellular communication and have raised great interest as drug delivery systems. Several engineering methods have been investigated for vesicle loading. Here, we studied the electroporation of EVs isolated from plasma to load antitumor microRNAs (miRNAs). First, we optimized the transfection protocol using miRNA cel-39 by evaluating different parameters (voltage and pulse) for their effect on vesicle morphology, loading capacity, and miRNA transfer to target cells. When compared with direct incubation of EVs with miRNA, mild electroporation allowed more efficient loading and better protection of miRNA from RNase degradation. Moreover, electroporation preserved the naive vesicle cargo, including RNAs and proteins, and their ability to be taken up by target cells, supporting the absence of vesicle damage. EVs engineered with antitumor miRNAs (miR-31 and miR-451a) successfully promoted apoptosis of the HepG2 hepatocellular carcinoma cell line, silencing target genes involved in anti-apoptotic pathways. Our findings indicate an efficient and functional miRNA encapsulation in plasma-derived EVs following an electroporation protocol that preserves EV integrity.

Published
2019
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48. Charge-based precipitation of extracellular vesicles.

Author

Deregibus MC, Figliolini F, D'Antico S, Manzini PM, Pasquino C, De Lena M, Tetta C, Brizzi MF, and Camussi G

Subjects
Adult, Apolipoproteins metabolism, Humans, Liver cytology, Nanoparticles chemistry, RNA metabolism, Saliva chemistry, Serum metabolism, Stem Cells metabolism, Ultracentrifugation, Chemical Precipitation, Extracellular Vesicles chemistry, Static Electricity
Abstract

Vesicular-mediated communication between cells appears critical in many biological processes. Extracellular vesicles (EVs) released from healthy and diseased cells are involved in a network of exchange of biologically active molecules. Since EVs present in biological fluids carry the signature of the cell of origin, they are potential biomarkers for ongoing physiological or pathological processes. Despite the knowledge on EV biology accrued in recent years, techniques of EV purification remain a challenge and all the described methods have some advantages and disadvantages. In the present study, we described a method based on charge precipitation of EVs from biological fluids and from cell supernatants in comparison with the differential ultracentrifugation, which is considered the gold standard for EV purification. The analysis of ζ‑potential revealed that EVs have a negative charge that allows the interaction with a positively charged molecule, such as protamine. Protamine was shown to induce EV precipitation from serum and saliva and from cell culture media without the need for ultracentrifugation. EV resuspension was facilitated when protamine (P) precipitation was performed in the presence of PEG 35,000 Da (P/PEG precipitation). The recovery of precipitated EVs evaluated by NanoSight analysis was more efficient than that obtained by ultracentrifugation. By electron microscopy the size of EVs was similar after both methods were used, and the expression of CD63, CD9 and CD81 exosomal markers in the P/PEG‑precipitated EVs indicated an enrichment in exosomes. The RNA recovery of P/PEG‑precipitated EVs was similar to that of EVs isolated by ultracentrifugation. In addition, P/PEG‑precipitated EVs retained the biological activity in vitro as observed by the induction of wound closure by keratinocytes and of proliferation of tubular epithelial cells. In conclusion, charge-based precipitation of EVs has the merit of simplicity and avoids the requirement of expensive equipments and may be used for the efficient isolation of EVs from small biological samples.

Published
2016
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