Hyperimmune immunoglobulin for people with COVID-19.


Journal

The Cochrane database of systematic reviews
ISSN: 1469-493X
Titre abrégé: Cochrane Database Syst Rev
Pays: England
ID NLM: 100909747

Informations de publication

Date de publication:
26 01 2023
Historique:
pmc-release: 26 01 2024
entrez: 26 1 2023
pubmed: 27 1 2023
medline: 28 1 2023
Statut: epublish

Résumé

Hyperimmune immunoglobulin (hIVIG) contains polyclonal antibodies, which can be prepared from large amounts of pooled convalescent plasma or prepared from animal sources through immunisation. They are being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). This review was previously part of a parent review addressing convalescent plasma and hIVIG for people with COVID-19 and was split to address hIVIG and convalescent plasma separately. To assess the benefits and harms of hIVIG therapy for the treatment of people with COVID-19, and to maintain the currency of the evidence using a living systematic review approach. To identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Research Database, the Cochrane COVID-19 Study Register, the Epistemonikos COVID-19 L*OVE Platform and Medline and Embase from 1 January 2019 onwards. We carried out searches on 31 March 2022. We included randomised controlled trials (RCTs) that evaluated hIVIG for COVID-19, irrespective of disease severity, age, gender or ethnicity. We excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies that evaluated standard immunoglobulin. We followed standard Cochrane methodology. To assess bias in included studies, we used RoB 2. We rated the certainty of evidence, using the GRADE approach, for the following outcomes: all-cause mortality, improvement and worsening of clinical status (for individuals with moderate to severe disease), quality of life, adverse events, and serious adverse events. We included five RCTs with 947 participants, of whom 688 received hIVIG prepared from humans, 18 received heterologous swine glyco-humanised polyclonal antibody, and 241 received equine-derived processed and purified F(ab') We included data from five RCTs that evaluated hIVIG compared to standard therapy, with participants with moderate-to-severe disease. As the studies evaluated different preparations (from humans or from various animals) and doses, we could not pool them. hIVIG prepared from humans may have little to no impact on mortality, and clinical improvement and worsening. hIVIG may increase grade 3-4 adverse events. Studies did not evaluate quality of life. RBD-specific polyclonal F(ab´)

Sections du résumé

BACKGROUND
Hyperimmune immunoglobulin (hIVIG) contains polyclonal antibodies, which can be prepared from large amounts of pooled convalescent plasma or prepared from animal sources through immunisation. They are being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). This review was previously part of a parent review addressing convalescent plasma and hIVIG for people with COVID-19 and was split to address hIVIG and convalescent plasma separately.
OBJECTIVES
To assess the benefits and harms of hIVIG therapy for the treatment of people with COVID-19, and to maintain the currency of the evidence using a living systematic review approach.
SEARCH METHODS
To identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Research Database, the Cochrane COVID-19 Study Register, the Epistemonikos COVID-19 L*OVE Platform and Medline and Embase from 1 January 2019 onwards. We carried out searches on 31 March 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that evaluated hIVIG for COVID-19, irrespective of disease severity, age, gender or ethnicity. We excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies that evaluated standard immunoglobulin.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology. To assess bias in included studies, we used RoB 2. We rated the certainty of evidence, using the GRADE approach, for the following outcomes: all-cause mortality, improvement and worsening of clinical status (for individuals with moderate to severe disease), quality of life, adverse events, and serious adverse events.
MAIN RESULTS
We included five RCTs with 947 participants, of whom 688 received hIVIG prepared from humans, 18 received heterologous swine glyco-humanised polyclonal antibody, and 241 received equine-derived processed and purified F(ab')
AUTHORS' CONCLUSIONS
We included data from five RCTs that evaluated hIVIG compared to standard therapy, with participants with moderate-to-severe disease. As the studies evaluated different preparations (from humans or from various animals) and doses, we could not pool them. hIVIG prepared from humans may have little to no impact on mortality, and clinical improvement and worsening. hIVIG may increase grade 3-4 adverse events. Studies did not evaluate quality of life. RBD-specific polyclonal F(ab´)

Identifiants

pubmed: 36700518
doi: 10.1002/14651858.CD015167.pub2
pmc: PMC9887673
doi:

Substances chimiques

Immunoglobulins 0

Banques de données

ClinicalTrials.gov
['NCT04453384', 'NCT04838821', 'NCT04891172']

Types de publication

Journal Article Review Systematic Review Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

CD015167

Informations de copyright

Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Auteurs

Catherine Kimber (C)

Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK.

Sarah J Valk (SJ)

Jon J van Rood Center for Clinical Transfusion Research, Sanquin/Leiden University Medical Center, Leiden, Netherlands.

Khai Li Chai (KL)

Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Vanessa Piechotta (V)

Cochrane Haematology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.

Claire Iannizzi (C)

Cochrane Haematology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.

Ina Monsef (I)

Cochrane Haematology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.

Erica M Wood (EM)

Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Abigail A Lamikanra (AA)

Clinical, Research and Development, NHS Blood and Transplant, Oxford, UK.

David J Roberts (DJ)

Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK.

Zoe McQuilten (Z)

Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Cynthia So-Osman (C)

Erasmus Medical Centre, Rotterdam, Netherlands.
Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, Netherlands.

Lise J Estcourt (LJ)

Haematology/Transfusion Medicine, NHS Blood and Transplant, Oxford, UK.

Nicole Skoetz (N)

Cochrane Haematology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.

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