Vasculitis & polymyalgia rheumatica

The Effect of Intranasal Niclosamide on Nasal Symptoms in Patients with Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Arthritis RheumatolPublished Secondary analysis of the PROTECT-V randomised trial

Authors' conclusion

These data are a signal of potential clinical effect on ENT manifestations in AAV.

Study context

Population
Patients with AAV from a single centre enrolled into the intranasal niclosamide arm of PROTECT-V (COVID-19 pre-exposure prophylaxis platform trial)
Participants
32 patients
Comparison
Intranasal niclosamide vs placebo
  • Niclosamiden = 14
  • Placebon = 18reference
Primary endpoint
ENT symptoms
Follow-up
During treatment
Methodological detailsdouble-blind, placebo-controlled, platform trial, single-centre subanalysis, retrospective clinical data collection, Researchers blinded to treatment allocation, Median treatment exposure 200 (IQR 109-251) days, Clinical data retrospectively collected for 9 months before, during, and 9 months after treatment
  • Double-blind
  • Placebo-controlled
  • Platform trial
  • Single-centre subanalysis
  • Retrospective clinical data collection
  • Researchers blinded to treatment allocation
  • Median treatment exposure 200 (IQR 109-251) days
  • Clinical data retrospectively collected for 9 months before, during, and 9 months after treatment

Primary result

As reported in the abstract

P = 0.04

Further findings

OutcomeNiclosamidePlacebo
ENT symptoms in PR3-ANCA-positive patients (subgroup) · during treatment0 events56%
  • Ear, nose, and throat (ENT) symptoms in PR3-ANCA-positive patients (subgroup): 0 of 10 vs 5 of 9

ENT symptoms, 9 months before and after treatment

No significant difference between groups

Original publication

The Effect of Intranasal Niclosamide on Nasal Symptoms in Patients with Antineutrophil Cytoplasmic Antibody–Associated Vasculitis. Arthritis Rheumatol. Published 23 February 2026. doi:10.1002/art.70061

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