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Article History

Received: 5 August 2025

Accepted: 11 September 2025

First Online: 31 October 2025

Declarations

:

: The study protocol was approved by the Institutional Review Board of Humanitas Research Hospital, approval n° 2085/2021. The trial is registered at ClinicalTrials.gov (NCT06491004) . All participants provided written informed consent.

: N/A.

: FB, PI, EG, CM, CR, CZ, and GG are employees of Diasorin, a manufacturer of in vitro diagnostic tests, including PTX3. AV has received consulting fees and honoraria from SILDEHA PHARMA, GSK, Angelini and Astra Zeneca, all not related to the submitted work. SA has received consulting fees, unrelated to the submitted work, from INSMED, ZAMBON, AstraZeneca, Menarini, Behring GmbH, Pfizer, Fondazione Internazionale Menarini, Moderna, Boehringer Ingelheim, Chiesi farmaceutica, MSD Italia, Vertex Pharmaceuticals, BRAHMS GMBH, Physioassist, AN2 Therapeutics, GlaxoSmithKline. Outside the submitted work, SA has also received funding for scientific advisory boards, travel, and speaker honoraria from GlaxoSmithKline, Fondazione Internazionale Menarini, INSMED, Boehringer Ingelheim, AstraZeneca UK, Zambon, Vertex Pharmaceuticals, MSD Italia, Verona pharma. Finally, a research grant non related to the submitted work was paid by GSK directly to the Institution of SA. AM is consultant/advisory board member for Novartis, Roche, Ventana, Pierre Fabre, Verily, Abbvie, BMS, J&J, Imcheck, Myeloid Therapeutics, Astra Zeneca, Biovelocita, BG Fund, Third Rock Venture, Biolegend Verseau Therapeutics, Macrophage pharma, Ellipses Pharma, Olatec Therapeutics, Moderna, Henlius, Myeloid therapeutics. These activities were not related to the submitted work. AM, CG, BB have IP and royalties related to PTX3. All other Authors do not have competing interests to disclose.