2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Vilobelimab

Nandita Nadig¹, Adarsh Bhimraj², Kelly Cawcutt³, Kathleen Chiotos⁴, Amy L Dzierba⁵, Arthur Y Kim^{6

7}, Greg S Martin⁸, Jeffrey C Pearson⁹, Amy Hirsch Shumaker^{10

11}, Lindsey R Baden^{6

12}, Roger Bedimo¹³, Vincent Chi-Chung Cheng¹⁴, Kara W Chew¹⁵, Eric S Daar¹⁶, David V Glidden¹⁷, Erica J Hardy¹⁸, Steven Johnson¹⁹, Jonathan Z Li^{6

12}, Christine MacBrayne²⁰, Mari M Nakamura^{21

22}, Laura Riley^{23

24}, Robert W Shafer²⁵, Shmuel Shoham²⁶, Pablo Tebas²⁷, Phyllis C Tien²⁸, Jennifer Loveless²⁹, Yngve Falck-Ytter^{10

11}, Rebecca L Morgan^{10

30}, Rajesh T Gandhi^{6

7}

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
² Division of Infectious Diseases, Houston Methodist Hospital, Houston, Texas, USA.
³ Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
⁴ Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia/University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁵ Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.
⁶ Harvard Medical School, Boston, Massachusetts, USA.
⁷ Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
⁸ Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Emory University, Atlanta, Georgia, USA.
⁹ Department of Pharmacy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹⁰ Department of Medicine, Case Western Reserve University, School of Medicine, Cleveland, Ohio, USA.
¹¹ Department of Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio, USA.
¹² Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹³ Department of Medicine, UT Southwestern/VA North Texas Health Care System, Dallas, Texas, USA.
¹⁴ Department of Microbiology, Queen Mary Hospital, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.
¹⁵ Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
¹⁶ Department of Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
¹⁷ Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.
¹⁸ Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island, USA.
¹⁹ Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
²⁰ Department of Pharmacy, Children's Hospital Colorado, Aurora, Colorado, USA.
²¹ Antimicrobial Stewardship Program and Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts, USA.
²² Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
²³ New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, USA.
²⁴ Department of Obstetrics and Gynecology, Weill Cornell Medicine, New York, New York, USA.
²⁵ Department of Medicine, Stanford University, Palo Alto, California, USA.
²⁶ Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
²⁷ Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁸ Department of Medicine, UCSF/VA San Francisco Health Care System, San Francisco, California, USA.
²⁹ Clinical Affairs and Practice Guidelines, Infectious Diseases Society of America, Arlington, Virginia, USA.
³⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

PMID: 40402009
PMCID: PMC12809782 (available on 2026-05-22)
DOI: 10.1093/cid/ciaf235

Practice Guideline

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Vilobelimab

Nandita Nadig et al. Clin Infect Dis. 2026.

. 2026 Jan 16;81(Supplement_3):i13-i16.

doi: 10.1093/cid/ciaf235.

Authors

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
² Division of Infectious Diseases, Houston Methodist Hospital, Houston, Texas, USA.
³ Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
⁴ Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia/University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁵ Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.
⁶ Harvard Medical School, Boston, Massachusetts, USA.
⁷ Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
⁸ Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Emory University, Atlanta, Georgia, USA.
⁹ Department of Pharmacy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹⁰ Department of Medicine, Case Western Reserve University, School of Medicine, Cleveland, Ohio, USA.
¹¹ Department of Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio, USA.
¹² Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹³ Department of Medicine, UT Southwestern/VA North Texas Health Care System, Dallas, Texas, USA.
¹⁴ Department of Microbiology, Queen Mary Hospital, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.
¹⁵ Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
¹⁶ Department of Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
¹⁷ Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.
¹⁸ Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island, USA.
¹⁹ Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
²⁰ Department of Pharmacy, Children's Hospital Colorado, Aurora, Colorado, USA.
²¹ Antimicrobial Stewardship Program and Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts, USA.
²² Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
²³ New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, USA.
²⁴ Department of Obstetrics and Gynecology, Weill Cornell Medicine, New York, New York, USA.
²⁵ Department of Medicine, Stanford University, Palo Alto, California, USA.
²⁶ Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
²⁷ Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁸ Department of Medicine, UCSF/VA San Francisco Health Care System, San Francisco, California, USA.
²⁹ Clinical Affairs and Practice Guidelines, Infectious Diseases Society of America, Arlington, Virginia, USA.
³⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

PMID: 40402009
PMCID: PMC12809782 (available on 2026-05-22)
DOI: 10.1093/cid/ciaf235

Abstract

This article provides a focused update to the clinical practice guideline on the treatment and management of patients with coronavirus disease 2019 (COVID-19), developed by the Infectious Diseases Society of America. The guideline panel presents a recommendation on the use of vilobelimab in hospitalized adults with critical COVID-19. The recommendation is based on evidence derived from a systematic literature review and adheres to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach.

Keywords: COVID-19; SARS-CoV-2; guideline; monoclonal antibody; vilobelimab.

© The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest . Evaluation of relationships as potential conflicts of interest (COIs) is determined by a review process. The assessment of disclosed relationships for possible COIs is based on the relative weight of the financial relationship (ie, monetary amount) and the relevance of the relationship (ie, the degree to which an association might reasonably be interpreted by an independent observer as related to the topic or recommendation of consideration). The following panelists have scientific advisory/consultant roles with indicated companies that are not related to the topic of COVID-19: R. B. with Merck and Gilead, E. S. D. with Gilead, D. V. G. with Merck and Gilead, S. S. with Pfizer (concluded), P. T. with Merck, and R. T. G. with Merck. The following panelists have scientific advisory/consultant roles with indicated companies that are related to COVID-19 but not critical COVID-19: R. B. with Shionogi, K. C. with Pardes Biosciences (concluded), A. Y. K. with Shionogi, S. S. with Adamis and Immunome (concluded), and P. T. with Shionogi. J. C. P. had a scientific advisory/consultant role (concluded) with InflaRx related to vilobelimab. His participation was carefully managed during discussions, and he recused himself from all voting. No disclosures were reported for all other authors (the majority of panelists), including chair and vice chair. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Additional information. More detailed information on the analysis and development of the recommendation is available in the Supplementary Material.

References

1. Cugno M, Meroni PL, Gualtierotti R, et al. Complement activation in patients with COVID-19: a novel therapeutic target. J Allergy Clin Immunol 2020; 146:215–7. - PMC - PubMed
1. Chouaki Benmansour N, Carvelli J, Vivier E. Complement cascade in severe forms of COVID-19: recent advances in therapy. Eur J Immunol 2021; 51:1652–9. - PMC - PubMed
1. Carvelli J, Demaria O, Vély F, et al. Association of COVID-19 inflammation with activation of the C5a-C5aR1 axis. Nature 2020; 588:146–50. - PMC - PubMed
1. US Food and Drug Administration . Emergency Use Authorization (EUA) for vilobelimab (IFX-1) Center for Drug Evaluation and Research (CDER) review. Available at: https://www.fda.gov/media/167044/download?attachment. Accessed 15 September 2024.
1. Vlaar APJ, Witzenrath M, van Paassen P, et al. Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med 2022; 10:1137–46. - PMC - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Vilobelimab

Affiliations

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Vilobelimab

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous