Hyperimmune Globulin for Severely Immunocompromised Patients Hospitalized With Coronavirus Disease 2019: A Randomized, Controlled Trial

被引：17

作者：

Huygens, Sammy ^{[1
,2
]}

Hofsink, Quincy ^{[3
]}

Nijhof, Inger S. ^{[4
,5
]}

Goorhuis, Abraham ^{[6
]}

Kater, Arnon P. ^{[3
]}

te Boekhorst, Peter A. W. ^{[7
]}

Swaneveld, Francis ^{[8
]}

Bogers, Susanne ^{[9
]}

Welkers, Matthijs R. A. ^{[10
]}

Papageorgiou, Grigorios ^{[11
]}

Rijnders, Bart J. ^{[1
,2
]}

Heijmans, Jarom ^{[3
,12
]}

NovotnY, Vera M. J. ^{[8
]}

机构：

[1] Erasmus MC, Dept Internal Med, Sect Infect Dis, Rotterdam, Netherlands

[2] Erasmus MC, Dept Med Microbiol & Infect Dis, Rotterdam, Netherlands

[3] Amsterdam UMC Locat Univ Amsterdam, Dept Hematol, Amsterdam, Netherlands

[4] Amsterdam UMC Locat Vrije Univ Amsterdam, Dept Hematol, Amsterdam, Netherlands

[5] St Antonius Hosp, Dept Internal Med Hematol, Nieuwegein, Netherlands

[6] Amsterdam UMC Locat Univ Amsterdam, Dept Infect Dis, Amsterdam, Netherlands

[7] Erasmus MC, Dept Hematol, Rotterdam, Netherlands

[8] Sanquin Blood Supply Fdn, Unit Transfus Med, Amsterdam, Netherlands

[9] Erasmus MC, Dept Virosci, Rotterdam, Netherlands

[10] Amsterdam UMC Locat Univ Amsterdam, Dept Med Microbiol & Infect Prevent, Amsterdam, Netherlands

[11] Erasmus MC, Dept Biostat, Rotterdam, Netherlands

[12] Amsterdam UMC Locat Univ Amsterdam, Dept Internal Med, Amsterdam, Netherlands

来源：

JOURNAL OF INFECTIOUS DISEASES | 2023年 / 227卷 / 02期

关键词：

anti-SARS-CoV-2 hyperimmune globulin; B-cell dysfunction; COVID-19; plasma-derived antibody therapy; severely immunocompromised state;

D O I：

10.1093/infdis/jiac334

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Anti-SARS-CoV-2 hyperimmune globulin (COVIG) could be a therapy for severely immunocompromised, hospitalized, COVID-19 patients. We performed a randomized, placebo-controlled trial in which a single intravenous infusion with 15 grams of COVIG significantly reduced the progression to severe COVID-19. Background The aim of this randomized, controlled trial is to determine whether antisevere acute respiratory syndrome coronavirus 2 hyperimmune globulin (COVIG) protects against severe coronavirus disease 2019 (COVID-19) in severely immunocompromised, hospitalized, COVID-19 patients. Methods Patients were randomly assigned to receive COVIG or intravenous immunoglobulin (IVIG) without SARS-CoV-2 antibodies. Results Severe COVID-19 was observed in 2 of 10 (20%) patients treated with COVIG compared to 7 of 8 (88%) in the IVIG control group (P = .015, Fisher's exact test). Conclusions Antisevere acute respiratory syndrome coronavirus 2 hyperimmune globulin may be a valuable treatment in severely immunocompromised, hospitalized, COVID-19 patients and should be considered when no monoclonal antibody therapies are available.

引用

页码：206 / 210

页数：5

共 15 条

[1] Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial [J].

Begin, Philippe ;

Callum, Jeannie ;

Jamula, Erin ;

Cook, Richard ;

Heddle, Nancy M. ;

Tinmouth, Alan ;

Zeller, Michelle P. ;

Beaudoin-Bussieres, Guillaume ;

Amorim, Luiz ;

Bazin, Renee ;

Loftsgard, Kent Cadogan ;

Carl, Richard ;

Chasse, Michael ;

Cushing, Melissa M. ;

Daneman, Nick ;

Devine, Dana, V ;

Dumaresq, Jeannot ;

Fergusson, Dean A. ;

Gabe, Caroline ;

Glesby, Marshall J. ;

Li, Na ;

Liu, Yang ;

McGeer, Allison ;

Robitaille, Nancy ;

Sachais, Bruce S. ;

Scales, Damon C. ;

Schwartz, Lisa ;

Shehata, Nadine ;

Turgeon, Alexis F. ;

Wood, Heidi ;

Zarychanski, Ryan ;

Finzi, Andres ;

Arnold, Donald M. .

NATURE MEDICINE, 2021, 27 (11) :2012-+

[2] Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients [J].

Boyarsky, Brian J. ;

Werbel, William A. ;

Avery, Robin K. ;

Tobian, Aaron A. R. ;

Massie, Allan B. ;

Segev, Dorry L. ;

Garonzik-Wang, Jacqueline M. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 325 (21) :2204-2206

[3] Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19 A Randomized Clinical Trial [J].

Estcourt, Lise J. ;

Turgeon, Alexis F. ;

McQuilten, Zoe K. ;

McVerry, Bryan J. ;

Al-Beidh, Farah ;

Annane, Djillali ;

Arabi, Yaseen M. ;

Arnold, Donald M. ;

Beane, Abigail ;

Begin, Philippe ;

van Bentum-Puijk, Wilma ;

Berry, Lindsay R. ;

Bhimani, Zahra ;

Birchall, Janet E. ;

Bonten, Marc J. M. ;

Bradbury, Charlotte A. ;

Brunkhorst, Frank M. ;

Buxton, Meredith ;

Callum, Jeannie L. ;

Chasse, Michael ;

Cheng, Allen C. ;

Cove, Matthew E. ;

Daly, James ;

Derde, Lennie ;

Detry, Michelle A. ;

De Jong, Menno ;

Evans, Amy ;

Fergusson, Dean A. ;

Fish, Matthew ;

Fitzgerald, Mark ;

Foley, Claire ;

Goossens, Herman ;

Gordon, Anthony C. ;

Gosbell, Iain B. ;

Green, Cameron ;

Haniffa, Rashan ;

Harvala, Heli ;

Higgins, Alisa M. ;

Hills, Thomas E. ;

Hoad, Veronica C. ;

Horvat, Christopher ;

Huang, David T. ;

Hudson, Cara L. ;

Ichihara, Nao ;

Laing, Emma ;

Lamikanra, Abigail A. ;

Lamontagne, Francois ;

Lawler, Patrick R. ;

Linstrum, Kelsey ;

Litton, Edward .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 326 (17) :1690-1702

[4] Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection [J].

Gharbharan, Arvind ;

Jordans, Carlijn C. E. ;

GeurtsvanKessel, Corine ;

den Hollander, Jan G. ;

Karim, Faiz ;

Mollema, Femke P. N. ;

Stalenhoef-Schukken, Janneke E. ;

Dofferhoff, Anthonius ;

Ludwig, Inge ;

Koster, Adrianus ;

Hassing, Robert-Jan ;

Bos, Jeannet C. ;

van Pottelberge, Geert R. ;

Vlasveld, Imro N. ;

Ammerlaan, Heidi S. M. ;

Leeuwen-Segarceanu, Elena M. van ;

Miedema, Jelle ;

van der Eerden, Menno ;

Schrama, Thijs J. ;

Papageorgiou, Grigorios ;

te Boekhorst, Peter ;

Swaneveld, Francis H. ;

Mueller, Yvonne M. ;

Schreurs, Marco W. J. ;

van Kampen, Jeroen J. A. ;

Rockx, Barry ;

Okba, Nisreen M. A. ;

Katsikis, Peter D. ;

Koopmans, Marion P. G. ;

Haagmans, Bart L. ;

Rokx, Casper ;

Rijnders, Bart J. A. .

NATURE COMMUNICATIONS, 2021, 12 (01)

[5] Quantitative analysis of mRNA-1273 COVID-19 vaccination response in immunocompromised adult hematology patients [J].

Haggenburg, Sabine ;

Lissenberg-Witte, Birgit, I ;

van Binnendijk, Rob S. ;

den Hartog, Gerco ;

Bhoekhan, Michel S. ;

Haverkate, Nienke J. E. ;

de Rooij, Dennis M. ;

van Meerloo, Johan ;

Cloos, Jacqueline ;

Kootstra, Neeltje A. ;

Wouters, Dorine ;

Weijers, Suzanne S. ;

van Leeuwen, Ester M. M. ;

Bontkes, Hetty J. ;

Tonouh-Aajoud, Saida ;

Heemskerk, Mirjam H. M. ;

Sanders, Rogier W. ;

Roelandse-Koop, Elianne ;

Hofsink, Quincy ;

Groen, Kazimierz ;

Cetinel, Lucia ;

Schellekens, Louis ;

den Hartog, Yvonne M. ;

Toussaint, Belle ;

Kant, Iris M. J. ;

Graas, Thecla ;

de Pater, Emma ;

Dik, Willem A. ;

Engel, Marije D. ;

Pierie, Cheyenne R. N. ;

Janssen, Suzanne R. ;

van Dijkman, Edith ;

Poniman, Meliawati ;

Burger, Judith A. ;

Bouhuijs, Joey H. ;

Smits, Gaby ;

Rots, Nynke Y. ;

Zweegman, Sonja ;

Kater, Arnon P. ;

van Meerten, Tom ;

Mutsaers, Pim G. N. J. ;

van Doesum, Jaap A. ;

Broers, Annoek E. C. ;

van Gils, Marit J. ;

Goorhuis, Abraham ;

Rutten, Caroline E. ;

Hazenberg, Mette D. ;

Nijhof, Inger S. .

BLOOD ADVANCES, 2022, 6 (05) :1537-1546

[6] Nature does things well [J].

不详 .

EXERCER-LA REVUE FRANCOPHONE DE MEDECINE GENERALE, 2022, (184) :288-288

[7] Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial [J].

Horby, Peter W. ;

Landray, Martin J. .

LANCET, 2021, 397 (10289) :2049-2059

[8]

Lacombe K., 2022, ABSTRACTS 37 INT C I

[9] SARS-CoV-2 neutralising antibody testing in Europe: towards harmonisation of neutralising antibody titres for better use of convalescent plasma and comparability of trial data [J].

Nguyen, Dung ;

Simmonds, Peter ;

Steenhuis, Maurice ;

Wouters, Elise ;

Desmecht, Daniel ;

Garigliany, Mutien ;

Romano, Marta ;

Barbezange, Cyril ;

Maes, Piet ;

Van Holm, Bram ;

Mendoza, Joaquin ;

Oyonarte, Salvador ;

Fomsgaard, Anders ;

Lassauniere, Ria ;

Zusinaite, Eva ;

Rus, Katarina Resman ;

Avsic-Zupanc, Tatjana ;

Reimerink, Johan H. J. ;

Brouwer, Fiona ;

Hoogerwerf, Marieke ;

Reusken, Chantal B. E. M. ;

Grodeland, Gunnveig ;

Le Cam, Sophie ;

Gallian, Pierre ;

Amroun, Abdennour ;

Brisbarre, Nadege ;

Martinaud, Christophe ;

Goffart, Isabelle Leparc ;

Schrezenmeier, Hubert ;

Feys, Hendrik B. ;

van der Schoot, C. Ellen ;

Harvala, Heli .

EUROSURVEILLANCE, 2021, 26 (27)

[10] Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial [J].

Polizzotto, Mark N. ;

Nordwall, Jacqueline ;

Babiker, Abdel G. ;

Phillips, Andrew ;

Vock, David M. ;

Eriobu, Nnakelu ;

Kwaghe, Vivian ;

Paredes, Roger ;

Mateu, Lourdes ;

Ramachandruni, Srikanth ;

Narang, Rajeev ;

Jain, Manua K. ;

Lazarte, Susana M. ;

Baker, Jason, V ;

Frosch, Anne E. P. ;

Poulakou, Garyfallia ;

Syrigos, Konstantinos N. ;

Amoczy, Gretchen S. ;

McBride, Natalie A. ;

Robinson, Philip A. ;

Sarafian, Farjad ;

Bhagani, Sanjay ;

Taha, I. Lassan S. ;

Benfield, Thomas ;

Liu, Sean T. H. ;

Antoniadou, Anastasia ;

Jensen, Jens Ulrik Staehr ;

Kalomenidis, Ioannis ;

Susilo, Adityo ;

Hariadi, Prasetyo ;

Jensen, Tomas O. ;

Morales-Rull, Jose Luis ;

Helleberg, Marie ;

Meegada, Sreenath ;

Johansen, Isik S. ;

Canario, Daniel ;

Fernandez-Cruz, Eduardo ;

Metallidis, Simeon ;

Shah, Amish ;

Sakurai, Aki ;

Koulouris, Nikolaus G. ;

Trounan, Robin ;

Weintrob, Amy C. ;

Podlekareva, Dania ;

Hadi, Usman ;

Lloyd, Kathryn M. ;

Roge, Birgit Thorup ;

Saito, Sho ;

Sweenis, Kelly ;

Malin, Jakob J. .

LANCET, 2022, 399 (10324) :530-540

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