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Infectious Diseases Volume 56, 2024 - Issue 6
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Research Articles

Double-blinded, randomised, placebo-controlled trial of convalescent plasma for COVID-19: analyses by neutralising antibodies homologous to recipients’ variants

T. Khawajaa Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;b Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland;d FIMAR, Multidisciplinary Center of Excellence in Antimicrobial Resistance Research, University of Helsinki, Helsinki, FinlandView further author information
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M. Kajovaa Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;b Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland;d FIMAR, Multidisciplinary Center of Excellence in Antimicrobial Resistance Research, University of Helsinki, Helsinki, FinlandView further author information
,
I. Levonena Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, FinlandView further author information
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J. P. Pietiläa Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland;d FIMAR, Multidisciplinary Center of Excellence in Antimicrobial Resistance Research, University of Helsinki, Helsinki, FinlandView further author information
,
H. Välimaaa Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;e Department of Virology, University of Helsinki, Helsinki, FinlandView further author information
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J. Paajanena Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;f Department of Pulmonary Medicine, Heart and Lung Center, University of Helsinki and Helsinki University Hospital, Helsinki, FinlandView further author information
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S. H. Pakkanena Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland;d FIMAR, Multidisciplinary Center of Excellence in Antimicrobial Resistance Research, University of Helsinki, Helsinki, FinlandView further author information
,
A. Patjasa Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland;d FIMAR, Multidisciplinary Center of Excellence in Antimicrobial Resistance Research, University of Helsinki, Helsinki, FinlandView further author information
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R. Montonene Department of Virology, University of Helsinki, Helsinki, FinlandView further author information
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S. Miettinene Department of Virology, University of Helsinki, Helsinki, Finland;g Department of Veterinary Biosciences, Faculty of Veterinary Medicine, University of Helsinki, Helsinki, FinlandView further author information
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J. Virtanene Department of Virology, University of Helsinki, Helsinki, Finland;g Department of Veterinary Biosciences, Faculty of Veterinary Medicine, University of Helsinki, Helsinki, FinlandView further author information
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T. Smurae Department of Virology, University of Helsinki, Helsinki, FinlandView further author information
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T. Sironene Department of Virology, University of Helsinki, Helsinki, Finland;g Department of Veterinary Biosciences, Faculty of Veterinary Medicine, University of Helsinki, Helsinki, FinlandView further author information
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R. Fagerlunde Department of Virology, University of Helsinki, Helsinki, FinlandView further author information
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H. Ugurlue Department of Virology, University of Helsinki, Helsinki, FinlandView further author information
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R. Iheozor-Ejiofore Department of Virology, University of Helsinki, Helsinki, Finland;g Department of Veterinary Biosciences, Faculty of Veterinary Medicine, University of Helsinki, Helsinki, FinlandView further author information
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K. Sakselae Department of Virology, University of Helsinki, Helsinki, Finland;h HUS Diagnostic Centre, HUSLAB, Clinical Microbiology, Helsinki University Hospital, Helsinki, FinlandView further author information
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T. Vahlbergi Department of Biostatistics, University of Turku and Turku University Hospital, Turku, FinlandView further author information
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A. Rankij Department of Dermatology, Allergology and Venereology, University of Helsinki and Helsinki University Hospital, Helsinki, FinlandView further author information
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A. Vierikkok Finnish Red Cross Blood Service, Helsinki, FinlandView further author information
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J. Ihalainenk Finnish Red Cross Blood Service, Helsinki, FinlandView further author information
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O. Vapalahtie Department of Virology, University of Helsinki, Helsinki, Finland;g Department of Veterinary Biosciences, Faculty of Veterinary Medicine, University of Helsinki, Helsinki, Finland;h HUS Diagnostic Centre, HUSLAB, Clinical Microbiology, Helsinki University Hospital, Helsinki, FinlandView further author information
&
A. Kantelea Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;b Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;c Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland;d FIMAR, Multidisciplinary Center of Excellence in Antimicrobial Resistance Research, University of Helsinki, Helsinki, FinlandCorrespondence[email protected]
View further author information
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Pages 423-433 | Received 18 Dec 2023, Accepted 08 Mar 2024, Published online: 21 Mar 2024

References

  • Luke TC, Kilbane EM, Jackson JL, et al. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006;145(8):599–609. doi: 10.7326/0003-4819-145-8-200610170-00139.
  • Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015;211(1):80–90. doi: 10.1093/infdis/jiu396.
  • Directorate-General for Health and Food Safety An EU programme of COVID-19 convalescent plasma collection and transfusion: guidance on collection, testing, processing, storage, distribution and monitored use. Brussels: european Comission; 2021.
  • Joyner MJ, Bruno KA, Klassen SA, et al. Safety update: COVID-19 convalescent plasma in 20,000 hospitalized patients. Mayo Clin Proc. 2020;95(9):1888–1897. doi: 10.1016/j.mayocp.2020.06.028.
  • Franchini M, Cruciani M, Casadevall A, et al. Safety of COVID-19 convalescent plasma: a definitive systematic review and meta-analysis of randomized controlled trials. Transfusion. 2023;64(2):388–399. doi: 10.1111/trf.17701.
  • Agarwal A, Mukherjee A, Kumar G, et al. 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. doi: 10.1136/bmj.m3939.
  • Li L, Zhang W, Hu Y, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19. JAMA. 2020;324(5):460–470. doi: 10.1001/jama.2020.10044.
  • Simonovich VA, Burgos Pratx LD, Scibona P, et al. A randomized trial of convalescent plasma in covid-19 severe pneumonia. N Engl J Med. 2021;384(7):619–629. doi: 10.1056/NEJMoa2031304.
  • Joyner MJ, Senefeld JW, Klassen SA, et al. Effect of convalescent plasma on mortality among hospitalized patients with COVID-19: initial three-Month experience. medRxiv. 2020;2020.08.12.20169359. doi: 10.1101/2020.08.12.20169359.
  • Abani O, Abbas A, Abbas F, et al. Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. The Lancet. 2021;397(10289):2049–2059. doi: 10.1016/S0140-6736(21)00897-7.
  • Cabrera LE, Pekkarinen PT, Alander M, et al. Characterization of low-density granulocytes in COVID-19. PLoS Pathog. 2021;17(7):e1009721. doi: 10.1371/journal.ppat.1009721.
  • Jalkanen P, Kolehmainen P, Häkkinen HK, et al. COVID-19 mRNA vaccine induced antibody responses against three SARS-CoV-2 variants. Nat Commun. 2021;12(1):3991. doi: 10.1038/s41467-021-24285-4.
  • Kantele A, Lääveri T, Kareinen L, et al. SARS-CoV-2 infections among healthcare workers at helsinki university hospital, Finland, spring 2020: serosurvey, symptoms and risk factors. Travel Med Infect Dis. 2021;39:101949. doi: 10.1016/j.tmaid.2020.101949.
  • Kurki SN, Kantonen J, Kaivola K, et al. APOE epsilon4 associates with increased risk of severe COVID-19, cerebral microhaemorrhages and post-COVID mental fatigue: a finnish biobank, autopsy and clinical study. Acta Neuropathol Commun. 2021;9(1):199. doi: 10.1186/s40478-021-01302-7.
  • Al‐Riyami AZ, Burnouf T, Yazer M, et al. International forum on the collection and use of COVID‐19 convalescent plasma: protocols, challenges and lessons learned: summary. Vox Sang. 2021;116(10):1117–1135. doi: 10.1111/vox.13113.
  • European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the preparation, use and quality assurance of blood components. 20th ed. Strasbourg: Council of Europe; 2020.
  • Tong A, Baumgart A, Evangelidis N, et al. Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery. Crit Care Med. 2021;49(3):503–516. doi: 10.1097/CCM.0000000000004817.
  • Marshall JC, Murthy S, Diaz J, et al. A minimal common outcome measure set for COVID-19 clinical research. The Lancet Infect Dis. 2020;20(8):e192–e7. doi: 10.1016/S1473-3099(20)30483-7.
  • Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveillance: bulletin Europeen Sur Les Maladies Transmissibles = Eur Commun Dis Bull. 2020;25(3):23–30.
  • Vauhkonen H, Nguyen PT, Kant R, et al. Introduction and rapid spread of SARS-CoV-2 omicron variant and dynamics of BA.1 and BA.1.1 sublineages, Finland, december 2021. Emerg Infect Dis. 2022;28(6):1229–1232. doi: 10.3201/eid2806.220515.
  • Truong Nguyen PT, Plyusnin I, Sironen T, et al. HAVoC, a bioinformatic pipeline for reference-based consensus assembly and lineage assignment for SARS-CoV-2 sequences. BMC Bioinformatics. 2021;22(1):373. doi: 10.1186/s12859-021-04294-2.
  • Haveri A, Smura T, Kuivanen S, et al. Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, january to february 2020. Euro Surveillance: bulletin Europeen Sur Les Maladies Transmissibles = Eur Commun Dis Bull. 2020;25(11):16–21.
  • Virtanen J, Uusitalo R, Korhonen EM, et al. Kinetics of neutralizing antibodies of COVID-19 patients tested using clinical D614G, B.1.1.7, and B 1.351 isolates in microneutralization assays. Viruses. 2021;13(6):996. doi: 10.3390/v13060996.
  • Kant R, Nguyen PT, Blomqvist S, et al. Incidence trends for SARS-CoV-2 alpha and beta variants, Finland, spring 2021. Emerg Infect Dis. 2021;27(12):3137–3141. doi: 10.3201/eid2712.211631.
  • Fred SM, Kuivanen S, Ugurlu H, et al. Antidepressant and antipsychotic drugs reduce viral infection by SARS-CoV-2 and fluoxetine shows antiviral activity against the novel variants in vitro. Front Pharmacol. 2021;12:755600. doi: 10.3389/fphar.2021.755600.
  • Knip M, Parviainen A, Turtinen M, et al. SARS-CoV-2 and type 1 diabetes in children in Finland: an observational study. Lancet Diabetes Endocrinol. 2023;11(4):251–260. doi: 10.1016/S2213-8587(23)00041-4.
  • Jokinen M, Edelman S, Krohn K, et al. Neutralizing natural anti-IL-17F autoantibodies protect autoimmune polyendocrine syndrome type 1 (APS-1) patients from asthma. Clin Immunol. 2020;219:108512. doi: 10.1016/j.clim.2020.108512.
  • Focosi D, Franchini M, Pirofski LA, et al. COVID-19 convalescent plasma and clinical trials: understanding conflicting outcomes. Clin Microbiol Rev. 2022;35(3):e0020021. doi: 10.1128/cmr.00200-21.
  • Jacobs JL, Haidar G, Mellors JW. COVID-19: Challenges of viral variants. Annu Rev Med. 2023;74(1):31–53. doi: 10.1146/annurev-med-042921-020956.
  • Rössler A, Riepler L, Bante D, et al. SARS-CoV-2 omicron variant neutralization in serum from vaccinated and convalescent persons. N Engl J Med. 2022;386(7):698–700. doi: 10.1056/NEJMc2119236.
  • Iannizzi C, Chai KL, Piechotta V, et al. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
  • Bhimraj AMR, Shumaker AH, Baden L, et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19.: Infectious Diseases Society of America; 2023 [cited 2024 25th Jan]. Available from: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/.
  • National Institutes of Health. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. [cited 2024 25th Jan]. Available from: https://www.covid19treatmentguidelines.nih.gov/.
  • Levine AC, Fukuta Y, Huaman MA, et al. Coronavirus disease 2019 convalescent plasma outpatient therapy to prevent outpatient hospitalization: a meta-analysis of individual participant data from 5 randomized trials. Clin Infect Dis. 2023;76(12):2077–2086. doi: 10.1093/cid/ciad088.
  • Libster R, Pérez Marc G, Wappner D, et al. Early high-titer plasma therapy to prevent severe covid-19 in older adults. N Engl J Med. 2021;384(7):610–618. doi: 10.1056/NEJMoa2033700.
  • Sullivan DJ, Gebo KA, Shoham S, et al. Early outpatient treatment for covid-19 with convalescent plasma. N Engl J Med. 2022;386(18):1700–1711. doi: 10.1056/NEJMoa2119657.
  • Bar KJ, Shaw PA, Choi GH, et al. A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia. J Clin Investig. 2021;131(24) doi: 10.1172/JCI155114.
  • Misset B, Piagnerelli M, Hoste E, et al. Convalescent plasma for covid-19–induced ARDS in mechanically ventilated patients. N Engl J Med. 2023;389(17):1590–1600. doi: 10.1056/NEJMoa2209502.
  • Horby P, Lim WS, Emberson JR, Recovery Collaborative Group., et al. Dexamethasone in hospitalized patients with covid-19. N Engl J Med. 2021;384(8):693–704.
  • Senefeld JW, Gorman EK, Johnson PW, et al. Mortality rates among hospitalized patients with COVID-19 treated with convalescent plasma: a systematic review and meta-analysis. Mayo Clin Proc Innov Qual Outcomes. 2023;7(5):499–513. doi: 10.1016/j.mayocpiqo.2023.09.001.
  • Bartelt LA, Markmann AJ, Nelson B, et al. Outcomes of convalescent plasma with defined high versus lower neutralizing antibody titers against SARS-CoV-2 among hospitalized patients: CoronaVirus inactivating plasma (CoVIP) study. mBio. 2022;13(5):e0175122. doi: 10.1128/mbio.01751-22.
  • Casadevall A, Joyner MJ, Pirofski LA, et al. Convalescent plasma therapy in COVID-19: unravelling the data using the principles of antibody therapy. Expert Rev Respir Med. 2023;17(5):381–395.
  • Sullivan DJ, Franchini M, Joyner MJ, et al. Analysis of anti-SARS-CoV-2 omicron-neutralizing antibody titers in different vaccinated and unvaccinated convalescent plasma sources. Nat Commun. 2022;13(1):6478. doi: 10.1038/s41467-022-33864-y.
  • Cantoni D, Wilkie C, Bentley EM, et al. Correlation between pseudotyped virus and authentic virus neutralisation assays, a systematic review and meta-analysis of the literature. Front Immunol. 2023;14:1184362. doi: 10.3389/fimmu.2023.1184362.
  • Franchini M, Focosi D, Percivalle E, et al. Variant of concern-Matched COVID-19 convalescent plasma usage in seronegative hospitalized patients. Viruses. 2022;14(7):1443. doi: 10.3390/v14071443.
  • Bastard P, Rosen LB, Zhang Q, et al. Autoantibodies against type I IFNs in patients with life-threatening COVID-19. Science. 2020;370(6515) doi: 10.1126/science.abd4585.

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