S282: A Randomized Controlled Clinical Trial Demonstrates That Plasma From Convalescent and Vaccinated Donors Improves Outcome of Covid-19 in Patients With Hematological Disease, Cancer or Immunosuppression

Müller-Tidow, C.; Janssen, M.; Schäkel, U.; Gall, J.; Leo, Albrecht; Stelmach, P.; Krisam, Johannes; Baumann, Lukas; Stermann, J.; Merle, U.; Zeier, Martin; Weigand, M.A.; Bullinger, Lars; Schrezenmeier, Jens-Florian; Bornhäuser, Martin; Alakel, Nael; Witzke, O.; Wolf, T.; Vehreschild, M. J.; Schmiedel, Stefan; Addo, Marylyn M.; Herth, F.; Kreutner, M; Tepasse, Phil‐Robin; Hertenstein, Bernd; Hänel, Matthias; Morgner, Anke; Kiehl, Michael; Hopfer, Olaf; Wattad, M.-A.; Schimanski, CC; Celik, Cihan; Pohle, Thorsten; Ruhe, Matthias; Kern, W.; Schmitt, A; Schmitt, M.; Dreger, P.; Lorenz, H.-M.; Souto-Carneiro, M.; Halama, Neils; Meuer, S.; Kräusslich, H.-G.; Müller, B.; Bartenschlager, Ralf; Klemmer, J.; Kriegsmann, K.; Schlenk, R. F.; Denkinger, Claudia M.

doi:10.1097/01.hs9.0000844020.02619.0f

Cited by 3 publications

(5 citation statements)

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“…The literature search yielded 147 eligible studies, of which 9 controlled trials (4 randomized trials [20][21][22][23] and 5 cohort studies [24][25][26][27][28] ) were selected for meta-analysis, 13 uncontrolled large case series without individual patient data but totaling 358 patients were selected for descriptive analysis [29][30][31][32][33][34][35][36][37][38][39][40][41] , and 125 case reports/series totaling 265 patients met the eligibility criteria for individual patient data analysis, 35, . Reference 35 was included in both the descriptive analysis and the individual patient data analysis because individual patient data were available only for a subgroup of patients.…”

Section: Resultsmentioning

confidence: 99%

COVID-19 convalescent plasma for the treatment of immunocompromised patients: a systematic review

Senefeld

Franchini

Mengoli

et al. 2022

Preprint

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Immunosuppressed patients have increased risk for morbidity and mortality from COVID-19 because they less frequently mount antibody responses to vaccines and often cannot tolerate small-molecule antivirals. The Omicron variant of concern of SARS-CoV-2 has progressively defeated anti-Spike mAbs authorized so far, paving the way to a return to COVID-19 convalescent plasma (CCP) therapy. In this systematic review we performed a metanalysis of 6 controlled studies (including 2 randomized controlled trials; totaling 368 treated patients and 1119 control), an individual patient data analysis of 125 case reports/series (totaling 265 patients), and a descriptive analysis of 13 uncontrolled large case series without individual patient data available (totaling 358 patients). The metanalysis showed a risk ratio for mortality of 0.61 in treatment with CCP versus standard of care for immunosuppressed COVID-19 patients. On the basis of this evidence, we encourage initiation of high-titer CCP from vaccinees (hybrid plasma) in immunocompromised patients.

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Section: Resultsmentioning

confidence: 99%

COVID-19 convalescent plasma for the treatment of immunocompromised patients: a systematic review

Senefeld

Franchini

Mengoli

et al. 2022

Preprint

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“…49 Two further randomized trials which included a subgroup of immunosuppressed patients are available only as congress abstracts or preprints so far. 71,72 A total of 133 patients were included in the German RECOVER trial (NCT05200754), 71 patients with hematological malignancies, other cancers, or immunosuppression. Patients were randomized (1:1) to receive standard therapy alone or with CCP.…”

Section: Sars-cov-2 Antibody Concentration In Ccp Mattersmentioning

confidence: 99%

“…In the cohort with malignancies or immunosuppression, the patients in the CCP arm had a significantly shorter median time to clinical improvement of 13 days versus 32 days (p ¼ 0.01). 71 The CORIPLASM trial in France included 120 patients receiving standard therapy with CCP or without CCP (NCT04345991). The mortality rate at day 28 was not significantly different in the overall cohort (7% in the control group vs. 20% in the plasma group; HR: 0.51; CI: 0.2-1.32).…”

Section: Sars-cov-2 Antibody Concentration In Ccp Mattersmentioning

confidence: 99%

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Immune Plasma for the Treatment of COVID-19: Lessons Learned so far

et al. 2023

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COVID-19 convalescent plasma (CCP) has been explored as one of the treatment options for COVID-19. Results of many cohort studies and clinical trials have been recently published. At first glance, the results of the CCP studies appear to be inconsistent. However, it became clear that CCP is not beneficial if CCP with low anti-SARS-CoV-2 antibody concentrations is used, if it is administered late in advanced disease stages, and to patients who already mounted an antibody response against SARS-CoV-2 at the time of CCP transfusion. On the other hand, CCP may prevent progression to severe COVID-19 when very high-titer CCP is given early in vulnerable patients. Immune escape of new variants is a challenge for passive immunotherapy. While new variants of concern developed resistance to most clinically used monoclonal antibodies very rapidly, immune plasma from individuals immunized by both a natural SARS-CoV-2 infection and SARS-CoV-2 vaccination retained neutralizing activity against variants. This review briefly summarizes the evidence on CCP treatment to date and identifies further research needs. Ongoing research on passive immunotherapy is not only relevant for improving care for vulnerable patients in the ongoing SARS-CoV-2 pandemic, but even more as a model for passive immunotherapy in case of future pandemics with a newly evolving pathogen. Compared to other drugs, which must be newly developed in a pandemic (e.g., monoclonal antibodies, antiviral drugs), convalescent plasma is rapidly available, inexpensive to produce, and can be adaptive to viral evolution by selection of contemporary convalescent donors.

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“…In a recent RCT on 133 immunosuppressed patients, two 300 mL plasma units (collected from either convalescent or double-vaccinated donors) with nAb titers > 1:80 led to a clinically significant benefit in patients with hematological malignancies, other cancers, or immunosuppression (group 1, group 2, n = 71), with a median time to improvement of 10 days for vaccinated plasma, 13 days for CCP, and 32 days for the control [ 14 ].…”

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confidence: 99%

Clinical and Virological Response to Convalescent Plasma in a Chronic Lymphocytic Leukemia Patient with COVID-19 Pneumonia

Belcari

Conti

Mazzoni³

et al. 2022

Life

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The burden of COVID-19 remains unchanged for immunocompromised patients who do not respond to vaccines. Unfortunately, Omicron sublineages are resistant to monoclonal antibodies authorized in Europe so far, and small chemical antivirals have contraindications and toxicities that have not been studied in these patients. We report here the successful treatment of COVID-19 pneumonia lasting for 4 months after the transfusion of COVID-19 convalescent plasma (CCP) in a patient with severe immunosuppression due to both chronic lymphocytic leukemia and venetoclax treatment. The patient achieved a complete clinical, radiological and virological response after six transfusions (600 mL each) of high-titer CCP collected from triple-vaccinated and convalescent donors. This dramatic case adds to the mounting evidence of CCP efficacy in immunocompromised patients, provided that high-titer and large volumes are infused.

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S282: A Randomized Controlled Clinical Trial Demonstrates That Plasma From Convalescent and Vaccinated Donors Improves Outcome of Covid-19 in Patients With Hematological Disease, Cancer or Immunosuppression

Cited by 3 publications

References 0 publications

COVID-19 convalescent plasma for the treatment of immunocompromised patients: a systematic review

COVID-19 convalescent plasma for the treatment of immunocompromised patients: a systematic review

Immune Plasma for the Treatment of COVID-19: Lessons Learned so far

Clinical and Virological Response to Convalescent Plasma in a Chronic Lymphocytic Leukemia Patient with COVID-19 Pneumonia

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