Transfusion reactions associated with COVID-19 convalescent plasma in outpatient clinical trials

被引:3
|
作者
Huaman, Moises A. [1 ,36 ]
Raval, Jay S. [2 ]
Paxton, James H. [3 ]
Mosnaim, Giselle S. [4 ]
Patel, Bela [5 ]
Anjan, Shweta [6 ]
Meisenberg, Barry R. [7 ]
Levine, Adam C. [8 ,9 ]
Marshall, Christi E. [10 ]
Yarava, Anusha [11 ]
Shenoy, Aarthi G. [12 ]
Heath, Sonya L. [13 ]
Currier, Judith S. [14 ]
Fukuta, Yuriko [15 ]
Blair, Janis E. [16 ]
Spivak, Emily S. [17 ]
Petrini, Joann R. [18 ]
Broderick, Patrick B. [19 ]
Rausch, William [18 ]
Cordisco, MarieElena [18 ]
Hammel, Jean [20 ]
Greenblatt, Benjamin [20 ]
Cluzet, Valerie C. [21 ]
Cruser, Daniel [21 ]
Oei, Kevin [22 ]
Abinante, Matthew [22 ]
Hammitt, Laura L. [23 ]
Sutcliffe, Catherine G. [23 ]
Forthal, Donald N. [24 ]
Zand, Martin S. [25 ]
Cachay, Edward R. [26 ]
Kassaye, Seble G. [27 ]
Ram, Malathi
Wang, Ying [11 ]
Das, Piyali [11 ]
Lane, Karen [11 ]
McBee, Nichol A. [11 ]
Gawad, Amy L. [11 ]
Karlen, Nicky [11 ]
Ford, Daniel E. [28 ]
Laeyendecker, Oliver [29 ]
Pekosz, Andrew [30 ]
Klein, Sabra L. [30 ]
Ehrhardt, Stephan [31 ]
Lau, Bryan [31 ]
Baksh, Sheriza N. [31 ]
Shade, David M. [31 ]
Casadevall, Arturo
Hanley, Daniel F. [11 ]
Ou, Jiangda [11 ]
机构
[1] Univ Cincinnati, Dept Internal Med, Div Infect Dis, Cincinnati, OH USA
[2] Univ New Mexico, Sch Med, Dept Pathol, Albuquerque, NM USA
[3] Wayne State Univ, Dept Emergency Med, Detroit, MI USA
[4] NorthShore Univ Hlth Syst, Dept Med, Div Allergy & Immunol, Evanston, IL USA
[5] Univ Texas Hlth Sci Ctr Houston, Dept Med, Div Pulm & Crit Care Med, Houston, TX USA
[6] Univ Miami, Miller Sch Med, Dept Med, Div Infect Dis, Miami, FL USA
[7] Luminis Hlth, Annapolis, MD USA
[8] Rhode Isl Hosp, Dept Emergency Med, Providence, RI USA
[9] Brown Univ, Providence, RI USA
[10] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD USA
[11] Johns Hopkins Univ, Sch Med, Dept Neurol, Brain Injury Outcomes Div, Baltimore, MD USA
[12] MedStar Washington Hosp Ctr, Dept Med, Div Hematol & Oncol, Washington, DC USA
[13] Univ Alabama Birmingham, Dept Med, Div Infect Dis, Birmingham, AL USA
[14] Univ Calif Los Angeles, Dept Med, Div Infect Dis, Los Angeles, CA USA
[15] Baylor Coll Med, Dept Med, Sect Infect Dis, Houston, TX USA
[16] Mayo Clin Hosp, Dept Med, Div Infect Dis, Phoenix, AZ USA
[17] Univ Utah, Sch Med, Dept Med, Div Infect Dis, Salt Lake City, UT USA
[18] Nuvance Hlth, Danbury, CT USA
[19] Nuvance Hlth Danbury Hosp, Danbury, CT USA
[20] Nuvance Hlth Norwalk Hosp, Norwalk, CT USA
[21] Nuvance Hlth Vassar Bros Med Ctr, Poughkeepsie, NY USA
[22] Ascada Res, Fullerton, CA USA
[23] Johns Hopkins Univ, Johns Hopkins Bloomberg Sch Publ Hlth, Dept Int Hlth, Baltimore, MD USA
[24] Univ Calif Irvine, Dept Med, Div Infect Dis, Irvine, CA USA
[25] Univ Rochester, Med Ctr, Dept Med, Rochester, NY USA
[26] Univ Calif San Diego, Dept Med, Div Infect Dis, San Diego, CA USA
[27] Georgetown Univ, Med Ctr, Dept Med, Div Infect Dis, Washington, DC USA
[28] Johns Hopkins Univ, Sch Med, Inst Clin & Translat Res, Baltimore, MD USA
[29] NIAID, Div Intramural Res, Bethesda, MD USA
[30] Johns Hopkins Univ, Johns Hopkins Bloomberg Sch Publ Hlth, Dept Mol Microbiol & Immunol, Baltimore, MD USA
[31] Johns Hopkins Univ, Johns Hopkins Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA
[32] NorthShore Univ Hlth Syst, Dept Pathol & Lab Med, Evanston, IL USA
[33] Univ Calif Los Angeles, David Geffen Sch Med, Dept Pathol, Wing Kwai & Alice Lee Tsing Chung Transfus Serv, Los Angeles, CA USA
[34] Johns Hopkins Univ, Sch Med, Dept Med, Div Infect Dis, Baltimore, MD USA
[35] Univ Massachusetts, Chan Med Sch, Dept Med, Div Hematol & Oncol, Worcester, MA USA
[36] Univ Cincinnati, Coll Med, Dept Internal Med, Cincinnati, OH 45221 USA
[37] Johns Hopkins Sch Med, Dept Mol Microbiol, Baltimore, MD 21205 USA
[38] Johns Hopkins Sch Med, Dept Immunol, Baltimore, MD 21205 USA
基金
美国国家卫生研究院;
关键词
ADVERSE-REACTIONS; DIPHENHYDRAMINE; ACETAMINOPHEN; PLACEBO;
D O I
10.1111/trf.17485
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BackgroundCOVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials. Study Design and MethodsWe analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders. ResultsThe combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications. DiscussionOutpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19.
引用
收藏
页码:1639 / 1648
页数:10
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