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.
Humphrey, T. J. L., et al.BMC Infectious Diseases 2025; 25(1): 204.
Aims
This study aimed to examine whether the addition of intranasal niclosamide to standard COVID-19 prevention measures enhanced protection against the infection in vulnerable patients with kidney diease.
Interventions
Participants were randomised to either intranasal niclosamide or matched placebo.
Participants
1651 adult patients (≥18 years) with end-stage kidney disease on dialysis, with a kidney transplant or renal autoimmune conditions receiving immunosuppression therapy.
Outcomes
The primary endpoint was confirmed symptomatic COVID-19 infection. The secondary endpoints were confirmed SARS-CoV-2 infection including asymptomatic cases, severity of COVID-19 disease, as well as safety and all-cause mortality.
Follow-up
36 weeks starting from trial treatment
CET Conclusions
This paper reports on a randomised, placebo-controlled, double-blind trial in the prevention of symptomatic COVID-19 in at-risk renal patients. Intra-nasal niclosamide, or placebo preparation, was taken twice daily for 9 months. The study was 90% powered for a reduction in symptomatic COVID-19 from 15% to 10%, and 1500 patients would be required to fulfil this. Ultimately both the intranasal niclosamide and the placebo prepration proved difficult to tolerate due to airway irritation, and a very large proportion dropped out from both groups (40% niclosamide, 24% placebo). This could account for the lack of difference seen between the arms in the primary outcome, even if the treatment had been effective. Treatment also did not reduce the severity of COVID-19 infections or rates of hospitalisation in this analysis. In conclusion, this study showed that intranasal niclosamide did not reduce the risk of symptomatic COVID-19 infection in the at-risk renal population compared to placebo.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov: NCT04870333, EudraCT: 2020–004144‑28, CTRI/2022/03/040802