Anti-C5a antibody vilobelimab treatment and the effect on biomarkers of inflammation and coagulation in patients with severe COVID-19: a substudy of the  phase 2 PANAMO trial

We recently reported in the phase 3 PANAMO trial that selectively blocking complement 5a (C5a) with vilobelimab led to improved survival in critically ill COVID-19 patients. C5a is an important contributor to the innate immune system and can also activate the coagulation system. High C5a levels have...

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Bibliographic Details
Published in:Respiratory research 2022-12, Vol.23 (1), p.375-6, Article 375
Main Authors: Lim, Endry H T, Vlaar, Alexander P J, Bos, Lieuwe D J, van Vught, Lonneke A, Boer, Anita M Tuip-de, Dujardin, Romein W G, Habel, Maria, Xu, Zhongli, Brouwer, Matthijs C, van de Beek, Diederik, de Bruin, Sanne
Format: Article
Language:English
Subjects:
Biomarkers
C5a
Complement
Complement C5a
Complement inhibition
Correspondence
COVID-19
Dosage and administration
Humans
Inflammation - diagnosis
Inflammation - drug therapy
Monoclonal antibodies
SARS-CoV-2
Testing
Vilobelimab
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Summary:We recently reported in the phase 3 PANAMO trial that selectively blocking complement 5a (C5a) with vilobelimab led to improved survival in critically ill COVID-19 patients. C5a is an important contributor to the innate immune system and can also activate the coagulation system. High C5a levels have been reported in severely ill COVID-19 patients and correlate with disease severity and mortality. Previously, we assessed the potential benefit and safety of vilobelimab in severe COVID-19 patients. In the current substudy of the phase 2 PANAMO trial, we aim to explore the effects of vilobelimab on various biomarkers of inflammation and coagulation. Between March 31 and April 24, 2020, 17 patients with severe COVID-19 pneumonia were enrolled in an exploratory, open-label, randomised phase 2 trial. Blood markers of complement, endothelial activation, epithelial barrier disruption, inflammation, neutrophil activation, neutrophil extracellular trap (NET) formation and coagulopathy were measured using enzyme-linked immunosorbent assay (ELISA) or utilizing the Luminex platform. During the first 15 days after inclusion, change in biomarker concentrations between the two groups were modelled with linear mixed-effects models with spatial splines and compared. Eight patients were randomized to vilobelimab treatment plus best supportive care (BSC) and nine patients were randomized to BSC only. A significant decrease over time was seen in the vilobelimab plus BSC group for C5a compared to the BSC only group (p 
ISSN:1465-993X
1465-9921
1465-993X
DOI:10.1186/s12931-022-02278-1