☆ 4.6 Review

COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes

CLINICAL MICROBIOLOGY REVIEWS (2022)

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Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study

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Convalescent plasma treatment is associated with lower mortality and better outcomes in high-risk COVID-19 patients - propensity-score matched case-control study

Adam Tworek et al.

Summary: This study confirmed a significantly lower mortality rate in patients treated with convalescent plasma, with no significant differences in ventilator time, ICU stay, and overall hospitalization time between the two groups. Age, cardiac insufficiency, active cancer, ventilator requirement, and length of hospitalization significantly increased the risk of death in both groups.

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SARS-CoV-2 variants and convalescent plasma: reality, fallacies, and opportunities

Arturo Casadevall et al.

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SARS-CoV-2 Infection of Rhesus Macaques Treated Early with Human COVID-19 Convalescent Plasma

Jesse D. Deere et al.

Summary: Clinical studies on the use of convalescent plasma (CP) for COVID-19 treatment have produced conflicting results, possibly due to varying administration timing. CP's mechanism includes neutralizing antibodies but its efficacy, minimum therapeutic titer and optimal administration timing remain unresolved. Early treatment with CP may have limited efficacy.

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Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Peter W. Horby et al.

Summary: Convalescent plasma therapy did not improve survival or other clinical outcomes in hospitalized COVID-19 patients.

LANCET (2021)

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Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia A Randomized Clinical Trial

Francesco Menichetti et al.

Summary: The clinical trial comparing convalescent plasma (CP) plus standard therapy (ST) with ST alone in hospitalized patients with COVID-19 pneumonia showed that high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days.

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Molly A. Vickers et al.

Summary: After vaccination, recovered COVID-19 patients showed significant increases in spike-specific and neutralizing antibodies, surpassing levels seen in COVID-19 patients who were not vaccinated. Hence, recovered COVID-19 subjects who are vaccinated may be ideal candidates for CCP donation.

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Effects on mortality of early vs late administration of convalescent plasma in the treatment of Covid-19

Havva Kocayigit et al.

Summary: This study retrospectively investigated the effect of early convalescent plasma treatment on the recovery of clinical and laboratory parameters in ICU patients diagnosed with severe COVID-19. Results showed that there was no difference in mortality regardless of whether convalescent plasma was administered early or late in the course of treatment.

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Effect of Methylene Blue Pathogen Inactivation on the Integrity of Immunoglobulin M and G

Johannes Raster et al.

Summary: The study found that the use of methylene blue treatment of plasma does not inhibit the binding capacity of IgM and IgG to their epitopes, or the Fc receptor interaction of IgG.

TRANSFUSION MEDICINE AND HEMOTHERAPY (2021)

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COVID-19 convalescent plasma therapy: hit fast, hit hard!

Daniele Focosi et al.

VOX SANGUINIS (2021)

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Markers of Polyfunctional SARS-CoV-2 Antibodies in Convalescent Plasma

Harini Natarajan et al.

Summary: This study analyzed convalescent plasma samples and found a diverse range of antiviral activity among recovered individuals. In addition to viral neutralization, convalescent plasma samples contained antibodies with various Fc-dependent functions, providing diversified resistance against SARS-CoV-2. Some eligible donors exhibited high activity in their plasma samples, which could be accurately identified as polyfunctional with even single Fc Array features.

MBIO (2021)

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Article Multidisciplinary Sciences

Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

Manaf AlQahtani et al.

Summary: The pilot study suggests that CP therapy is safe in hospitalized COVID-19 patients, but there were no significant differences in primary and secondary outcome measures compared to standard therapy. A larger definitive study is needed for confirmation.

SCIENTIFIC REPORTS (2021)

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Article Medicine, General & Internal

Mortality due to COVID-19 infection: A comparison of first and second waves

Olubunmi Oladunjoye et al.

Summary: The USA faced two waves of COVID-19 cases in 2020, with higher mortality in the first wave and a higher proportion of Non-Hispanic Black and Hispanic patients. Mortality decreased in the second wave with an increase in the use of steroids, remdesivir, and convalescent plasma.

JOURNAL OF COMMUNITY HOSPITAL INTERNAL MEDICINE PERSPECTIVES (2021)

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Article Microbiology

A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19-A Propensity Score-Matched Control Analysis

Vasiliki Pappa et al.

Summary: A multicenter phase II study evaluated the efficacy and safety of convalescent plasma (CP) in severe COVID-19 patients, finding that CP recipients had significantly reduced risk of death, improved overall survival, and higher chances of extubation. Higher levels of antibodies in the CP were associated with reduced risk of death, and CP infusion was safe with minimal adverse events. Early use of CP may be a safe and effective treatment for severe COVID-19 patients.

MICROORGANISMS (2021)

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Letter Oncology

Bamlanivimab plus etesevimab therapy induces SARS-CoV-2 immune escape mutations and secondary clinical deterioration in COVID-19 patients with B-cell malignancies

F. Pommeret et al.

ANNALS OF ONCOLOGY (2021)

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Article Biology

Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden

Karin Holm et al.

Summary: The study aimed to investigate the efficacy of convalescent plasma in hospitalized COVID-19 patients, but no significant differences were observed between the convalescent plasma group and standard of care group.

BMC RESEARCH NOTES (2021)

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Editorial Material Infectious Diseases

COVID-19 infodemics: the role of mainstream and social media

Daniele Focosi et al.

CLINICAL MICROBIOLOGY AND INFECTION (2021)

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Article Medicine, General & Internal

CONVALESCENT plasma for COVID-19: A meta-analysis of clinical trials and real-world evidence

Chiraphat Kloypan et al.

Summary: Convalescent plasma treatment can reduce the risk of all-cause mortality in severe or critical COVID-19 patients. The study findings suggest that CP treatment is particularly effective in reducing mortality risk in patients with severe disease and when conducted in Asia.

EUROPEAN JOURNAL OF CLINICAL INVESTIGATION (2021)

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Article Infectious Diseases

SARS-CoV-2 neutralising antibody testing in Europe: towards harmonisation of neutralising antibody titres for better use of convalescent plasma and comparability of trial data

Dung Nguyen et al.

Summary: The research compared the performance of SARS-CoV-2 neutralising antibody testing among 12 European laboratories involved in convalescent plasma trials. It was found that there were significant differences in titres between laboratories during blind-testing, but calibration of titres reduced this variability. Harmonisation of neutralising antibody quantification is a crucial step towards determining protective and therapeutic levels of neutralising antibodies.

EUROSURVEILLANCE (2021)

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Article Infectious Diseases

Is convalescent plasma futile in COVID-19? A Bayesian re-analysis of the RECOVERY randomized controlled trial

F. W. Hamilton et al.

Summary: This study highlights the potential benefit of convalescent plasma in reducing mortality among COVID-19 patients, with varying effectiveness based on antibody status and timing of presentation. Patients who present within 7 days without detectable antibodies may experience a significant mortality reduction, while those already with antibodies may not derive as much benefit from convalescent plasma therapy. Bayeisan analysis provides valuable insights into treatment efficacy compared to traditional frequentist methods.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

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Article Medicine, General & Internal

Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial

Alberto M. Borobia et al.

Summary: To date, there are no immunological data on COVID-19 heterologous vaccination schedules in humans. This study evaluated the immunogenicity and reactogenicity of administering BNT162b2 as a second dose in individuals primed with ChAdOx1-S. The results showed that BNT162b2 induced a robust immune response in individuals prime vaccinated with ChAdOx1-S, with an acceptable and manageable reactogenicity profile.

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How Safe Is COVID-19 Convalescent Plasma?

Massimo Franchini et al.

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Article Multidisciplinary Sciences

High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape

Fabian Schmidt et al.

Summary: The number and variability of neutralizing epitopes targeted by polyclonal antibodies in individuals who have recovered from SARS-CoV-2 or been vaccinated play a crucial role in determining the breadth of neutralization and the genetic barrier to viral escape. Studying HIV-1 pseudotypes and plasma selection experiments, it was found that human polyclonal antibodies target multiple neutralizing epitopes within and outside the receptor-binding domain, and antibody targets coincide with spike sequences enriched for diversity in natural SARS-CoV-2 populations. Combining plasma-selected spike substitutions led to the generation of 'polymutant' spike protein pseudotypes that resist neutralization by polyclonal antibodies to a similar extent as circulating variants of concern. Plasma from individuals who had been infected with SARS-CoV-2 and subsequently received mRNA vaccination was able to neutralize highly resistant SARS-CoV-2 variants, suggesting that optimally elicited polyclonal antibodies can provide protection against future SARS-CoV-2 variations and potential sarbecovirus pandemics.

NATURE (2021)

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Article Biochemistry & Molecular Biology

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial

Philippe Begin et al.

Summary: Convalescent plasma did not reduce the risk of intubation or death at 30 days in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

NATURE MEDICINE (2021)

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Article Medicine, General & Internal

Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19

M. Dougan et al.

Summary: In this phase 3 trial, the combination of bamlanivimab plus etesevimab was found to reduce the incidence of Covid-19-related hospitalization and death among high-risk ambulatory patients compared to placebo, and also accelerated the decline in SARS-CoV-2 viral load.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Medicine, General & Internal

Early Convalescent Plasma for High-Risk Outpatients with Covid-19

Frederick K. Korley et al.

Summary: This study showed that administering Covid-19 convalescent plasma to high-risk outpatients within 1 week after symptom onset did not prevent disease progression.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Multidisciplinary Sciences

Early but not late convalescent plasma is associated with better survival in moderate-to-severe COVID-19

Neima Briggs et al.

Summary: The study found that early administration of CCP can improve outcomes in patients with moderate-to-severe COVID-19, while improvement was not observed with late administration of CCP. Timing of administration should be considered in future trials.

PLOS ONE (2021)

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Article Multidisciplinary Sciences

Ongoing global and regional adaptive evolution of SARS-CoV-2

Nash D. Rochman et al.

Summary: The evolution of SARS-CoV-2 during the COVID-19 pandemic is primarily characterized by purifying selection, with a small number of sites evolving under positive selection. Variants in the spike protein's receptor-binding domain and the nucleocapsid protein region with NLS are enriched with positively selected amino acid replacements. These replacements form a connected network of apparent epistatic interactions and are indicators of major partitions in the SARS-CoV-2 phylogeny. The global virus diversity has been steadily increasing, with distinct periods based on phylogenetic distances and key mutations.

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2021)

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Review Hematology

Use of convalescent plasma in COVID-19 patients with immunosuppression

Jonathon W. Senefeld et al.

Summary: Convalescent plasma therapy may benefit COVID-19 patients with immunosuppression by improving mortality rate and clinical outcomes, but further investigation is needed.

TRANSFUSION (2021)

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Article Hematology

SARS-CoV-2 antibody persistence in COVID-19 convalescent plasma donors: Dependency on assay format and applicability to serosurveillance

Clara Di Germanio et al.

Summary: The study found that antibody levels in COVID-19 convalescent plasma fluctuated over time, with direct detection methods showing increasing levels while indirect methods showed decreasing levels. Neutralization assays also showed declining responses, with different detection methods contributing to the variability in antibody stability over time.

TRANSFUSION (2021)

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Review Hematology

COVID-19 neutralizing antibody-based therapies in humoral immune deficiencies: A narrative review

Daniele Focosi et al.

Summary: The outbreak of COVID-19 has caused a global health crisis, with convalescent plasma being suggested as a potential treatment option. Research indicates that convalescent plasma may provide greater benefits for COVID-19 patients with humoral immune deficiencies.

TRANSFUSION AND APHERESIS SCIENCE (2021)

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Review Virology

COVID-19 Convalescent Plasma Is More than Neutralizing Antibodies: A Narrative Review of Potential Beneficial and Detrimental Co-Factors

Daniele Focosi et al.

Summary: In addition to specific antibodies, CCP may contain other factors that could have beneficial or detrimental effects on the treatment outcomes of COVID-19 patients, which warrants further investigation.

VIRUSES-BASEL (2021)

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Editorial Material Virology

SARS-CoV-2 Variants: A Synopsis of In Vitro Efficacy Data of Convalescent Plasma, Currently Marketed Vaccines, and Monoclonal Antibodies

Daniele Focosi et al.

Summary: This study summarizes the in vitro evidence of efficacy for convalescent plasma, approved vaccines and monoclonal antibodies against various SARS-CoV-2 variants, providing guidance for treating physicians while awaiting real-world clinical efficacy.

VIRUSES-BASEL (2021)

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Article Multidisciplinary Sciences

Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection

Arvind Gharbharan et al.

Summary: A clinical trial on 86 COVID-19 patients treated with convalescent plasma showed no overall clinical benefit, as most patients already had potent antibodies upon admission, leading to the trial being terminated prematurely.

NATURE COMMUNICATIONS (2021)

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Article Multidisciplinary Sciences

Mortality in individuals treated with COVID-19 convalescent plasma varies with the geographic provenance of donors

Katie L. Kunze et al.

Summary: Successful COVID-19 therapeutics and vaccines have utilized the immune response to the virus, but locally-evolving variants may impact treatment effectiveness. Near-sourced convalescent plasma has higher efficacy in causing death within 30 days of transfusion.

NATURE COMMUNICATIONS (2021)

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Article Biology

Convalescent plasma use in the USA was inversely correlated with COVID-19 mortality

Arturo Casadevall et al.

Summary: The usage of COVID-19 convalescent plasma (CCP) therapy in the USA was high in Fall 2020 but steadily declined in Spring 2021. A strong inverse correlation between CCP usage and mortality per admission was found, with a possible association between the decline in CCP usage and excess deaths during the pandemic.

ELIFE (2021)

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Article Oncology

Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19

Michael A. Thompson et al.

Summary: This study evaluated the association of convalescent plasma treatment with 30-day mortality in hospitalized adults with hematologic cancers and COVID-19. Results showed that convalescent plasma treatment was associated with improved 30-day mortality, especially in patients requiring intensive care unit admission or mechanical ventilatory support.

JAMA ONCOLOGY (2021)

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Review Medicine, General & Internal

Convalescent Plasma Therapy for COVID-19: A Graphical Mosaic of the Worldwide Evidence

Stephen A. Klassen et al.

Summary: Global evidence suggests that convalescent plasma can improve COVID-19 patient survival, particularly when transfused early in the disease course. Randomized controlled trials have shown limited or no benefit when transfused later in the disease course. Convalescent plasma also contributes to improved symptomatology and viral clearance, and has a similar safety profile as standard plasma.

FRONTIERS IN MEDICINE (2021)

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Review Medicine, General & Internal

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

Massimo Franchini et al.

Summary: This study aimed to summarize evidence on the efficacy and safety of convalescent plasma (CP) in treating COVID-19. Results showed a reduction in mortality with CP over standard therapy when administered early and at high titer, without increased adverse reactions, although there was variability in the certainty of the evidence.

DIAGNOSTICS (2021)

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Article Multidisciplinary Sciences

Effect of time and titer in convalescent plasma therapy for COVID-19

Paola de Candia et al.

Summary: The study results indicate that the use of convalescent plasma in early stages of COVID-19 can significantly reduce mortality, but its effectiveness is not significant in severe or critical conditions. Additionally, plasma with high antibody titers does not increase the benefit in reducing mortality.

ISCIENCE (2021)

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Article Infectious Diseases

Assessment of automated high-throughput serological assays for prediction of high-titer SARS-CoV-2 neutralizing antibody

Giovanna Moscato et al.

Summary: The study compared different immunoassay methods to predict serum samples with high neutralizing antibody titers, and found that Euroimmun(R) IgG and Ortho VITROS(R) Anti-SARS-CoV-2 IgG were the most suitable for predicting high titers of neutralizing antibodies.

JOURNAL OF CLINICAL VIROLOGY PLUS (2021)

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Article Medicine, Research & Experimental

A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia

Katharine J. Bar et al.

Summary: This study assessed the efficacy of CCP in severely ill, hospitalized adults with COVID-19 pneumonia, showing significant benefits in clinical severity score and 28-day mortality. The results suggest that CCP may benefit select populations, especially those with comorbidities who are treated early.

JOURNAL OF CLINICAL INVESTIGATION (2021)

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Letter Immunology

Emergence of SARS-COV-2 Spike Protein Escape Mutation Q493R after Treatment for COVID-19

Daniele Focosi et al.

Summary: This report demonstrates a novel mutation, Q493R, of the SARS-CoV-2 spike protein that confers resistance to both bamlanivimab and etesivimab, isolated from a patient who had received treatment with these drugs.

EMERGING INFECTIOUS DISEASES (2021)

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Article Medicine, Research & Experimental

Convalescent plasma associates with reduced mortality and improved clinical trajectory in patients hospitalized with COVID-19

Shanna A. Arnold Egloff et al.

Summary: The study showed that convalescent plasma (CP) is significantly associated with decreased risk of in-hospital mortality in patients with COVID-19, highlighting the importance of real-world evidence and the need for further evaluation before dismissing CP as a viable therapy.

JOURNAL OF CLINICAL INVESTIGATION (2021)

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Article Health Care Sciences & Services

Emergence of the E484K mutation in SARS-COV-2-infected immunocompromised patients treated with bamlanivimab in Germany

Bjoern Jensen et al.

Summary: The study indicates that treatment of SARS-CoV-2 with bamlanivimab in immunocompromised patients may result in the rapid development of immune escape variants, which could have significant implications for the effectiveness of vaccination and antibody-based therapies.

LANCET REGIONAL HEALTH-EUROPE (2021)

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Article Medicine, Research & Experimental

A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19

Max R. O'Donnell et al.

Summary: This study found that the use of convalescent plasma was not associated with significant improvement in the clinical status at day 28 for severe COVID-19 patients, but it was related to significantly improved survival rates.

JOURNAL OF CLINICAL INVESTIGATION (2021)

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Editorial Material Medicine, Research & Experimental

The convalescent sera option for containing COVID-19

Arturo Casadevall et al.

JOURNAL OF CLINICAL INVESTIGATION (2020)

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Article Multidisciplinary Sciences

Effectiveness of convalescent plasma therapy in severe COVID-19 patients

Kai Duan et al.

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2020)

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Editorial Material Hematology

Points to consider in the preparation and transfusion of COVID-19 convalescent plasma

Jay Epstein et al.

VOX SANGUINIS (2020)

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Article Pathology

Treatment of Coronavirus Disease 2019 Patients with Convalescent Plasma Reveals a Signal of Significantly Decreased Mortality

Eric Salazar et al.

AMERICAN JOURNAL OF PATHOLOGY (2020)

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Review Microbiology

Convalescent Plasma Therapy for COVID-19: State of the Art

Daniele Focosi et al.

CLINICAL MICROBIOLOGY REVIEWS (2020)

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Article Hematology

Mortality reduction in 46 patients with severe COVID-19 treated with hyperimmune plasma A proof-of-concept, single-arm, multicenter trial .

Cesare Perotti et al.

HAEMATOLOGICA (2020)

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Article Microbiology

A Replication-Competent Vesicular Stomatitis Virus for Studies of SARS-CoV-2 Spike-Mediated Cell Entry and Its Inhibition

M. Eugenia Dieterle et al.

CELL HOST & MICROBE (2020)

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Article Medicine, General & Internal

Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19 A Randomized Clinical Trial

Ling Li et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2020)

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Article Infectious Diseases

A minimal common outcome measure set for COVID-19 clinical research

J. C. Marshall et al.

LANCET INFECTIOUS DISEASES (2020)

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Article Medicine, General & Internal

Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients

Michael J. Joyner et al.

MAYO CLINIC PROCEEDINGS (2020)

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Review Microbiology

Pathogenesis of COVID-19 from the Perspective of the Damage-Response Framework

Liise-anne Pirofski et al.

MBIO (2020)

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Article Biochemistry & Molecular Biology

Convalescent plasma treatment of severe COVID-19: a propensity score-matched control study

Sean T. H. Liu et al.

NATURE MEDICINE (2020)

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Editorial Material Medicine, General & Internal

A living WHO guideline on drugs for covid-19

Francois Lamontagne et al.

BMJ-BRITISH MEDICAL JOURNAL (2020)

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Article Medicine, General & Internal

Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)

Anup Agarwal et al.

BMJ-BRITISH MEDICAL JOURNAL (2020)

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Review Microbiology

Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies

Wen Shi Lee et al.

NATURE MICROBIOLOGY (2020)

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Article Medicine, Research & Experimental

A simple protein-based surrogate neutralization assay for SARS-CoV-2

Kento T. Abe et al.

JCI INSIGHT (2020)

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Article Medicine, Research & Experimental

Convalescent plasma anti SARS-CoV-2 spike protein ectodomain and receptor-binding domain IgG correlate with virus neutralization

Eric Salazar et al.

JOURNAL OF CLINICAL INVESTIGATION (2020)

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Article Medicine, Research & Experimental

A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial

Timothy Devos et al.

TRIALS (2020)

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Article Respiratory System

A multicenter randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation: the CONFIDENT trial protocol

Benoit Misset et al.

BMC PULMONARY MEDICINE (2020)

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Letter Oncology

Clinical efficacy of convalescent plasma therapy on treating COVID-19 patients: Evidence from matched study and a meta-analysis

Weijun Jiang et al.

CLINICAL AND TRANSLATIONAL MEDICINE (2020)

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Article Infectious Diseases

Convalescent plasma for COVID-19: male gender, older age and hospitalisation associated with high neutralising antibody levels, England, 22 April to 12 May 2020

Jennifer Mehew et al.

EUROSURVEILLANCE (2020)

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Article Immunology

Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease Patients

Nisreen M. A. Okba et al.

EMERGING INFECTIOUS DISEASES (2020)

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Article Critical Care Medicine

Hark back: Passive immunotherapy for influenza and other serious infections

Thomas C. Luke et al.

CRITICAL CARE MEDICINE (2010)

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