Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review

Chai, Khai Li; Valk, Sarah J; Kimber, Catherine; Wood, Erica M.; Lamikanra, Abigail A.; Roberts, David D.; McQuilten, Zoe; So-Osman, Cynthia; Estcourt, Lise J; Skoetz, Nicole

doi:10.1002/14651858.cd013600.pub4

Cited by 92 publications

References 202 publications

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“…Preliminary results of the ACTIV-3/TICO trial of bamlanivimab in hospitalized patients with COVID-19 were reported after enrolment was terminated because futility guidelines were met 11,12 . Similarly, other neutralizing monoclonal products, convalescent plasma, and hyperimmune immunoglobulin products have not appeared to provide overall clinical benefit for such patients [13][14][15][16] .…”

Section: Introductionmentioning

confidence: 99%

Clinical and Virological Response to a Neutralizing Monoclonal Antibody for Hospitalized Patients with COVID-19

Lundgren

Activ

2021

Preprint

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BACKGROUND Bamlanivimab, a neutralizing monoclonal antibody given in combination with remdesivir, did not improve outcomes among hospitalized COVID-19 patients based on an early futility assessment. In this final study report, we evaluate an a priori hypothesis that greater benefit of bamlanivimab would be identified in those without detectable endogenous neutralizing antibody levels at study entry, especially if viral levels were high. METHODS Hospitalized COVID-19 patients were randomized to receive bamlanivimab (7000mg) or placebo and followed for 90 days for sustained recovery (home for 14 consecutive days); recovery rate ratios (RRRs) are cited. RESULTS Among 314 participants (163 on bamlanivimab and 151 on placebo), the median time to sustained recovery was 19 days and RRR=0.99 (95% CI: 0.79-1.22; p=0.89). At entry, 50% evidenced production of anti-spike neutralizing antibodies; 50% had SARS-CoV-2 nucleocapsid plasma antigen levels ≥ 1,000 ng/L. Among those without and with antibodies at study entry, the RRRs were 1.24 (95% CI: 0.90-1.70) and 0.74 (95% CI: 0.54-1.00) (p=0.02 for interaction). The RRRs were elevated for those with plasma antigen or nasal viral RNA levels above versus below median at entry, and was greatest for those without antibodies and with elevated antigen or viral RNA levels: 1.48 (95% CI: 0.99-2.23), 1.94 (1.25-3.00), respectively (p<0.05 for all interactions). Hazard ratios for safety outcomes also differed by serostatus at entry. CONCLUSIONS Sustained recovery after administration of bamlanivimab versus placebo differed by presence of neutralizing antibodies at study entry, especially if participants had markers of elevated viral replication. ClinicalTrials.gov number, NCT04501978.

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“…The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram is reported in Figure 1 . After the full texts were scrutinized against the inclusion and exclusion criteria, 29 SRs were included in the umbrella review [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 ] and 23 SRs were excluded [ 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , …”

Section: Resultsmentioning

confidence: 99%

“…Of the 29 SRs included in the overview, 26 were focused exclusively on COVID-19 [ 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 ], while three were focused on respiratory pandemics and on beta coronaviruses infections [ 10 , 19 , 30 ]. Two SRs [ 17 , 22 ] were a subgroup analysis of other reviews [ 16 , 21 ].…”

Section: Resultsmentioning

confidence: 99%

Safety and Efficacy of Convalescent Plasma in COVID-19: An Overview of Systematic Reviews

Franchini

Corsini²,

Focosi³

et al. 2021

Diagnostics

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Convalescent plasma (CP) from patients recovered from COVID-19 is one of the most studied anti-viral therapies against SARS-COV-2 infection. The aim of this study is to summarize the evidence from the available systematic reviews on the efficacy and safety of CP in COVID-19 through an overview of the published systematic reviews (SRs). A systematic literature search was conducted up to August 2021 in Embase, PubMed, Web of Science, Cochrane and Medrxiv databases to identify systematic reviews focusing on CP use in COVID-19. Two review authors independently evaluated reviews for inclusion, extracted data and assessed quality of evidence using AMSTAR (A Measurement Tool to Assess Reviews) and GRADE tools. The following outcomes were analyzed: mortality, viral clearance, clinical improvement, length of hospital stay, adverse reactions. In addition, where possible, subgroup analyses were performed according to study design (e.g., RCTs vs. non-RCTs), CP neutralizing antibody titer and timing of administration, and disease severity. The methodological quality of included studies was assessed using the checklist for systematic reviews AMSTAR-2 and the GRADE assessment. Overall, 29 SRs met the inclusion criteria based on 53 unique primary studies (17 RCT and 36 non-RCT). Limitations to the methodological quality of reviews most commonly related to absence of a protocol (11/29) and funding sources of primary studies (27/29). Of the 89 analyses on which GRADE judgements were made, effect estimates were judged to be of high/moderate certainty in four analyses, moderate in 38, low in 38, very low in nine. Despite the variability in the certainty of the evidence, mostly related to the risk of bias and inconsistency, the results of this umbrella review highlight a mortality reduction in CP over standard therapy when administered early and at high titer, without increased adverse reactions.

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“…The study of Cochrane, which included 12 RCTs, showed the same results. Compared with Cocharane ( 39 ), we included four new RCTs containing the results of the REMAP-CAP and the CONCOR-Study group. The researches of the two groups relatively reduced the impact of the large sample study, RECOVERY, to the results.…”

Section: Discussionmentioning

confidence: 99%

The Effectiveness of Convalescent Plasma for the Treatment of Novel Corona Virus Disease 2019: A Systematic Review and Meta-Analysis

Cao¹,

Ming²,

Chen

et al. 2021

Front. Med.

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Background: Coronavirus disease 2019 (COVID-19), sweeping across the world, has created a worldwide pandemic. Effective treatments of COVID-19 are extremely urgent.Objective: To analyze the efficacy and safety of convalescent plasma (CCP) on patients with COVID-19.Methods: All the relevant studies were searched from PubMed, EMBASE,Cochrane library, Scopus, Web of Science, CBM, CNKI, Wan fang, VIP, Medrxiv, Biorxiv, and SSRN on July 19, 2021. PICOS criteria were as follows: (P) the study interests were human subjects with the infection of COVID-19; (I) the intervention of interest was CCP; (C) comparator treatments contained placebo, sham therapy, and standard treatment; (O) the primary outcome was mortality rates by the novel coronavirus. The secondary outcomes included the incidence of serious adverse events, the rate of ICU admission and mechanical ventilation (MV); the length of hospital stay; the duration of MV and ICU stay; the antibody levels, inflammatory factor levels, and viral loads. (S) Only randomized controlled trials (RCTs) of CCP were included. Subanalysis, quality assessment, sensitive analysis, and publication bias were conducted by two reviewers independently.Results: Sixteen RCTs were included and enrolled a total of 16,296 participants in this meta-analysis. The pooled data showed that no significant difference was observed in reducing the rate of overall mortality between CCP treatment group and placebo group (OR 0.96; 95% CI 0.90 to 1.03; p = 0.30; I2 = 6%). According to the results of subgroup analysis, severe or critical patients with CCP showed significant difference in reducing the 28-day mortality of compared with placebo (OR 0.58, 95% CI 0.36 to 0.93, p = 0.02, I2 = 0%). CCP groups have a significantly shorter duration of MV compared with the control group (weighted MD −1.00, 95% CI −1.86 to −0.14 d p = 0.02, I2 = 0%). No significant difference was observed in the length of hospital stay, the duration of ICU, and the rate of ICU and MV. There is no conclusive evidence about the safety of CCP.Conclusion: Convalescent plasma can significantly reduce the 28-day mortality of severe or critical COVID-19 patients and the duration of MV. However, more evidence was needed to prove the safety of convalescent plasma.

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“…A year back, points to consider and questions were raised about applicability [6] , [7] , logistic issue, impact, safety and usefulness of plasma passive immunotherapy in Covid-19 patients [8] , [9] ; other issues dealing with ethics of plasma collection and allocation [10] , [11] , [12] , [13] , and best protocol scaling have been addressed, and some of these questions have been resolved. Large cohorts of treated patients versus controls have been scrutinized and results on efficacy were not as straightforward as initially expected [14] , [15] , [16] , [17] , [18] . An innumerable number of studies have been proposed for publication in journals of different specialties; as could have been anticipated, studies coming from almost unknown teams experienced difficulties to be published, contrary to the ones led by key opinion leaders.…”

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confidence: 99%

Convalescent Covid-19 plasma: Back-to-basics and ethics, and next steps

Garraud

Burnouf

2021

Transfusion Clinique et Biologique

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Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review

Abstract: Analysis 5.1. Comparison 5: Subgroup analysis: antibodies in recipients detected at baseline for the comparison of convalescent plasma versus placebo or standard care alone for individuals with moderate to severe disease, Outcome 1: All-cause mortality at up to day 28..

Cited by 92 publications

References 202 publications

Clinical and Virological Response to a Neutralizing Monoclonal Antibody for Hospitalized Patients with COVID-19

Safety and Efficacy of Convalescent Plasma in COVID-19: An Overview of Systematic Reviews

The Effectiveness of Convalescent Plasma for the Treatment of Novel Corona Virus Disease 2019: A Systematic Review and Meta-Analysis

Convalescent Covid-19 plasma: Back-to-basics and ethics, and next steps

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