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Table of Contents
EDITORIAL
Year : 2021  |  Volume : 11  |  Issue : 1  |  Page : 1-3

What's new in critical illness and injury science? Convalescent plasma for coronavirus disease-2019 patients with severe or critical illness


1 Department of Emergency Medicine, Nazareth Hospital, Philadelphia, PA, USA
2 Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA
3 Department of Internal Medicine, Nazareth Hospital, Philadelphia, PA, USA

Date of Submission11-Mar-2020
Date of Acceptance11-Mar-2020
Date of Web Publication27-Mar-2021

Correspondence Address:
Dr. Andrew Carl Miller
Department of Emergency Medicine, Nazareth Hospital, 2601 Holme Avenue, 3rd Floor, Marian Building, Philadelphia 19152, PA
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijciis.ijciis_26_21

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How to cite this article:
Miller AC, Ghadermarzi S, Venkatachalam S. What's new in critical illness and injury science? Convalescent plasma for coronavirus disease-2019 patients with severe or critical illness. Int J Crit Illn Inj Sci 2021;11:1-3

How to cite this URL:
Miller AC, Ghadermarzi S, Venkatachalam S. What's new in critical illness and injury science? Convalescent plasma for coronavirus disease-2019 patients with severe or critical illness. Int J Crit Illn Inj Sci [serial online] 2021 [cited 2021 Dec 1];11:1-3. Available from: https://www.ijciis.org/text.asp?2021/11/1/1/312262



Since emerging in December 2019, the coronavirus disease-2019 (COVID-19) pandemic caused by the beta-coronavirus severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) virus has resulted in over 118 million cases worldwide and over 2.62 million deaths (as of 11 March 2021). Roughly 20% of patients require hospitalization, with one-quarter of those necessitating intensive care unit (ICU) admission for reasons including refractory hypoxemia, shock, or multiple organ failure.[1],[2] The paucity of therapeutics with demonstrable efficacy has led many to employ less substantiated treatments supported by case series, small nonrandomized studies, or even intellectual intuition. Recently, we discussed the use of intravenous immunoglobulin.[3] This editorial focuses on convalescent plasma (CP) to treat COVID-19 patients with a severe or critical illness.

CP refers to plasma that is collected from individuals, following resolution of infection and development of antibodies.[4] It has been hypothesized that infusion of the SARS-CoV-2 neutralizing antibodies contained within this serum may improve patient outcomes. CP has been utilized to treat other infectious diseases with variable results, including outbreaks of other beta-coronaviruses (SARS-CoV-1, Middle East respiratory syndrome),[5] Ebola,[6] and influenza;[7] however, the efficacy of CP in critically ill patients with SARS-CoV-2 infection remains unclear.

Several nonrandomized studies indicated that CP treatment for patients with COVID-19 may be safe,[4],[8],[9] with variable results regarding mortality and clinical markers of critical illness.[10],[11],[12] Moreover, when combined with remdesivir, CP did not improve outcomes over remdesivir alone.[13] Despite this modest evidence, the United States Food and Drug Administration has approved the use of experimental CP therapy in clinical trials and critical COVID-19 patients without other treatment options.[14]

A listing of randomized controlled trials in adult patients with severe or critical illness due to COVID-19 is presented in [Table 1].[15],[16],[17],[18],[19] Four studies were excluded for including patients other than those with a severe or critical illness.[20],[21],[22],[23] Risk of bias was assessed for each study using the Cochrane risk-of-bias tool [Table 2], and evidence was graded according to the GRADE rating system.
Table 1: The characteristics of the included studies assessing convalescent plasma for management of coronavirus disease-2019 patients with severe or critical illness

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Table 2: Risk-of-bias analysis for randomized controlled trails of convalescent plasma for management of coronavirus disease-2019 patients with severe or critical illness

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The results of included studies are summarized in [Table 3]. When compared to usual care, CP treatment for COVID-19 with severe or critical illness does not show statistically significant benefit on hospital mortality (4 studies,[16],[17],[18],[19] 514 patients, CP 37 [11.7%] vs. usual care 33 [16.6%]; odds ratio [OR]: 0.74 [95% confidence interval [CI]: 0.44, 1.24); evidence certainty by GRADE criteria low). Furthermore, the incidence of serious adverse events was not statistically different between the groups (3 studies,[17],[18],[19] 485 patients, CP 55 [18.3%] vs. usual care 19 [10.3%]; OR: 1.44 [95% CI: 0.81, 2.56]; evidence certainty by GRADE criteria low). In addition, treatment with CP does not appear to improve hospital or ICU length of stay (data not presented due to space limitations). Finally, it should be noted that two of the studies are preprints,[15],[16] and a number of clinical trials have been undertaken (some abandoned), thus necessitating careful review once additional data are available.
Table 3: Summary of the clinical effects of convalescent plasma for management of coronavirus disease-2019 patients with severe or critical illness

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In conclusion, available evidence suggests that CP treatment for COVID-19 patients with a severe or critical illness does not decrease hospital mortality or increase rates of serious adverse events. Routine use of CP treatment for severe or critically ill COVID-19 patients without other indications for its use is not advised.



 
   References Top

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Stawicki SP, Jeanmonod R, Miller AC, Paladino L, Gaieski DF, Yaffee AQ, et al. The 2019-2020 novel coronavirus (severe acute respiratory syndrome coronavirus 2) pandemic: A joint American College of Academic International Medicine-World Academic Council of Emergency Medicine Multidisciplinary COVID-19 working group consensus paper. J Glob Infect Dis 2020;12:47-93.  Back to cited text no. 1
    
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Ahn DG, Shin HJ, Kim MH, Lee S, Kim HS, Myoung J, et al. Current status of epidemiology, diagnosis, therapeutics, and vaccines for novel coronavirus disease 2019 (COVID-19). J Microbiol Biotechnol 2020;30:313-24.  Back to cited text no. 2
    
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Miller AC, Venkatachalam S. What's new in critical illness and injury science? Intravenous immunoglobulin (IVIG) for COVID-19 severe or critical illness. Int J Crit Ill Inj Sci 2020;10:159-62.  Back to cited text no. 3
    
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Gemici A, Bilgen H, Erdoğan C, Kansu A, Olmuşçelik O, Beköz HS, et al. A single center cohort of 40 severe COVID-19 patients who were treated with convalescent plasma Turk J Med Sci 2020;50:1781-5.  Back to cited text no. 4
    
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Dean CL, Hooper JW, Dye JM, Zak SE, Koepsell SA, Corash L, et al. Characterization of Ebola convalescent plasma donor immune response and psoralen treated plasma in the United States. Transfusion 2020;60:1024-31.  Back to cited text no. 6
    
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Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, et al. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis 2011;52:447-56.  Back to cited text no. 7
    
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Erkurt MA, Sarici A, Berber İ, Kuku İ, Kaya E, Özgül M. Life-saving effect of convalescent plasma treatment in covid-19 disease: Clinical trial from eastern Anatolia. Transfus Apher Sci 2020;59:102867.  Back to cited text no. 8
    
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González SE, Regairaz L, Ferrando NS, González Martínez VV, Salazar MR, Estenssoro E. Convalescent plasma therapy in COVID-19 patients, in the province of Buenos Aires. Medicina (B Aires) 2020;80:417-24.  Back to cited text no. 9
    
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Liu ST, Lin HM, Baine I, Wajnberg A, Gumprecht JP, Rahman F, et al. Convalescent plasma treatment of severe COVID-19: A propensity score-matched control study. Nat Med 2020;26:1708-13.  Back to cited text no. 11
    
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Moniuszko-Malinowska A, Czupryna P, Zarębska-Michaluk D, Tomasiewicz K, Pancewicz S, Rorat M, et al. Convalescent plasma transfusion for the treatment of COVID-19-experience from Poland: A multicenter study. J Clin Med 2020;10:28.  Back to cited text no. 13
    
14.
Center for Biologics Evaluation and Research. Docket Number FDA-2020-D-1825: Investigational COVID-19 Convalescent Plasma Guidance for Industry. United States Food and Drug Administration; 11 February, 2021. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-covid-19-convalescent-plasma. [Last accessed on 11 Mar 21].  Back to cited text no. 14
    
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AlQahtani M, Abdulrahman A, Almadani A, Alali SY, Al Zamrooni AM, Hejab AH, et al. Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease. medRxiv 2020. Available from: https://www. medrxiv.org/content/101101/2020.11.02.20224303 v1. [Last accessed on 11 Mar 21].  Back to cited text no. 15
    
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Bajpai M, Kumar S, Maheswari A, Chhabra K, Kale P, Gupta A, et al. Efficacy of convalescent plasma therapy compared to fresh frozen plasma in severely Ill COVID-19 patients: A pilot randomized controlled trial. medRxiv 2020. Available from: https://www.medrxiv.org/content/100.1101/2020.10.25.20219337 v1. [Last accessed on 11 Mar 21].  Back to cited text no. 16
    
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Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial. JAMA 2020;324:460-70.  Back to cited text no. 17
    
18.
Rasheed AM, Fatak DF, Hashim HA, Maulood MF, Kabah KK, Almusawi YA, et al. The therapeutic potential of convalescent plasma therapy on treating critically-ill COVID-19 patients residing in respiratory care units in hospitals in Baghdad, Iraq. Infez Med 2020;28:357-66.  Back to cited text no. 18
    
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Simonovich VA, Burgos Pratx LD, Scibona P, Beruto MV, Vallone MG, Vázquez C, et al. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med 2021;384:619-29.  Back to cited text no. 19
    
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Agarwal A, Muckerjee A, Kumar G, Chatterjee P, Bhatnagar T, Malhotra P, PLACID trial collaborators. Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial). BMJ 2020;371:m3939.  Back to cited text no. 20
    
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Gharbharan A, Jordans CC, Guertsvankessel C, den Hollander JG, Karin M, Mollema FP, et al. Convalescent plasma for COVID-19. Randomized clinical trial. medRxiv 2020. Available from: https://www.medrxiv.org/content/100.1101/2020.07.01.20139857v1. [Last accessed on 11 Mar 21].  Back to cited text no. 21
    
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Avendano-Sola C, Ramos-Martinez A, Munez-Rubio E, Ruiz-Antoran B, de Molina RM, Torres F, et al. Convalescent Plasma for COVID-19. Randomized Clinical Trial. medRxiv 2020. Available from: https://www.medrxiv.org/content/100.1101/2020.07.01.20139857v1. [Last accessed on 11 Mar 21].  Back to cited text no. 22
    
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Balcells ME, Rojas L, Le Corre N, Martinez-Valdebenito C, Ceballos ME, Ferres M, et al. Early Anti-SARS-CoV-2 convalescent plasma in patients admitted for COVD-19: A randomized phase II clinical trial. medRxiv 2020. Available from: https://www. medrxiv.org/content/10.1101/2020.09.170.20196212v1. [Last accessed on 11 Mar 21].  Back to cited text no. 23
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]


This article has been cited by
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[Pubmed] | [DOI]



 

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