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The following is a summary of “Prophylaxis for renal patients at risk of COVID-19 infection: results from the intranasal niclosamide randomised, double blinded, placebo controlled arm of the PROTECT-V platform trial,” published in the February 2025 issue of BMC Infectious Diseases by Humphrey et al.
Despite vaccination, underlying health conditions left many patients vulnerable to coronavirus disease 2019 (COVID-19) infection and poorer outcomes due to suboptimal vaccine responses.
Researchers conducted a retrospective study to evaluate whether intranasal niclosamide provided additional protection against COVID-19 beyond standard preventive measures, including vaccination.
They evaluated PROTECT-V (PROphylaxis for paTiEnts at risk of COVID-19 infecTion), a platform trial assessing in individuals with multiple pre-exposure prophylactic agents for COVID-19. This study analyzed data from the randomized, double-blind, placebo-controlled intranasal niclosamide arm. A total of 1,651 adults on dialysis, with a kidney transplant, or with renal autoimmune conditions receiving immunosuppression were randomized across 48 sites (37 UK; 11 Indian). Participants received either intranasal niclosamide or a matched placebo twice daily for up to 9 months. The primary outcome was the time to symptomatic COVID-19 infection.
The results showed that 1,651 individuals were randomized (826 niclosamide; 825 placebo) between February 2021 and November 2022. Among them, 655 (39.7%) were undergoing dialysis, 622 (37.7%) had a kidney transplant, and 374 (22.7%) had a renal autoimmune disease. The COVID-19 vaccination was received by 97.5% in the UK and 66.4% in India, with similar proportions across treatment groups. Despite no adverse safety signals, withdrawal rates were high (40% niclosamide; 23.8% placebo) due to upper airway irritation, leading to shorter treatment duration in the niclosamide group, 103 individuals receiving niclosamide had symptomatic COVID-19 infection and 133 in the placebo group (estimated hazard ratio 1.02 [95% CI 0.79–1.32]).
Investigators concluded that intranasal niclosamide was not effective in reducing the risk of symptomatic COVID-19 infection compared to placebo.
Source: bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-025-10584-4
