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The European Conference on Infections in Leukaemia (ECIL-10) guidelines for COVID-19 should take convalescent plasma into proper consideration

Leukemia volume 39, pages 2302–2303 (2025)Cite this article

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We read with interest the updated version of the ECIL guidelines for COVID-19 based upon a meeting in Nice, France in the fall of 2024. Hence, we recognize that the document may not include recent studies and developments, such as the licensing of COVID-19 convalescent plasma (CCP) in the United States for use in immunocompromised patients. Currently, COVID-19 requiring hospitalization is primarily a disease of hem-onc patients, and as such guidelines such as ECIL have major implications for these patients. When ECIL-9 guidelines on COVID-19 were published in 2022 [1], we requested a revision [2] given that those guidelines ignored evidence for the lack of efficacy of anti-Spike monoclonal antibodies (mAbs) and evidence for the efficacy of COVID-19 convalescent plasma (CCP). Unfortunately, the 2025 ECIL-10 latest update continues to promulgate many problematic recommendations [3].

Namely, the ECIL guidelines ignore the hard evidence that CCP currently represents the only antiviral therapy for which reductions in both hospitalizations and mortality has been specifically tested and proven in two rigorous randomized controlled trials (RCT) specifically targeting hem-onc patients [4, 5], one of which was published in 2025. This top-level evidence is not available for any other antiviral in this population, and definitively there is no RCT at all available for their “prolonged administration, repeated courses“ that the authors are advocating. The 2025 recommendation judged moderate support for CCP use in newly intubated patients from a RCT when same level of RCT evidence exists for outpatient and inpatient use in the immunocompromised. Accordingly, a systematic review analyzing the experience with 1800 patients found that CCP usage led to a 0.65 odds ratio for mortality in immunocompromised (IC) patients [6], and an individual patient data metanalysis of 570 B-cell depleted patients found 86.5% 60-day survival and 70.1% SARS-CoV-2 clearance with CCP [7], with more dramatic results seen in the patients treated with the highest titer “VaxPlasma”. These results are clearly superior to those achieved in clinical practice with other antivirals on such patients. It is noteworthy that these results were achieved while using CCP as monotherapy, and not in combination with mAbs, as the authors suggest in recommendations 52 and 53: such combinations appear not only unnecessary but also impracticable, given the unavailability of effective anti-Spike mAbs in Europe [8] (same applies to recommendation 54 regarding pre-exposure prophylaxis). Finally, the statement that “CCP was issued in the USA by an emergency use authorization in immunocompromised patients with COVID-19” should be updated, since FDA has now fully licensed a first blood establishment to manufacture CCP for IC patients in January 2025, after the Nice ECIL meeting [9]. A higher level of evidence is required for licensing than for emergency use allowance.

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References

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Authors and Affiliations

  1. North-Western Tuscany Blood Bank, Pisa University Hospital, Pisa, Italy

    Daniele Focosi

  2. Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

    Arturo Casadevall & David J. Sullivan

  3. Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA

    Michael J. Joyner

  4. Department of Transfusion Medicine and Hematology, Carlo Poma Hospital, Mantua, Italy

    Massimo Franchini

Authors
  1. Daniele Focosi
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  2. Arturo Casadevall
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  3. David J. Sullivan
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  4. Michael J. Joyner
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  5. Massimo Franchini
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Contributions

MF first noted problems in the referred paper. DF wrote the initial draft. AC, DJS, and MJJ revised the manuscript. All authors have approved the final version of this manuscript.

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Correspondence to Daniele Focosi.

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Focosi, D., Casadevall, A., Sullivan, D.J. et al. The European Conference on Infections in Leukaemia (ECIL-10) guidelines for COVID-19 should take convalescent plasma into proper consideration. Leukemia 39, 2302–2303 (2025). https://doi.org/10.1038/s41375-025-02691-7

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