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
Toby J L Humphrey, Wendi Qian, Michael Chen-Xu, Francis Dowling, Katrina Gatley, Rakshya Adhikari, Tracey Hensman, Louise Stockley, Abhinav Bassi, Nikita Bathla, Indranil Dasgupta, Davinder P S Dosanjh, Mads Jellingsø, Per Sørensen, Morten Lind Jensen, Anne Weibel Callesen, John R Bradley, Vivekanand Jha, Morten O A Sommer, Thomas F Hiemstra, Rona M Smith, Bassam Alchi, Abdulfattah Alejmi, Neil Basu, Charlotte Bebb, Samira Bell, Anudita Bhargava, Sunil Bhandari, Coralie Bingham, Kate Bramham, Fergus Caskey, Sourabh Chand, Dhruva Chaudhry, Arpita Ray Chaudhury, Sashidhar Chennamsetty, Nihil Chitalia, Paramit Chowdhury, Simon Curran, Simon Davies, Rachel Davison, Michael Delaney, Vishal Dey, Jonathan Dick, Mahmoud Eid, Ragada El-Damanawi, Sarah Fluck, Rouvick Gama, Christopher Goldsmith, Effrossyni Gkrania-Klotsas, Sian Griffin, Richard Hull, Avinash Ignatius, David Jayne, Colin Jones, Manivarma Kamalnathan, Nitin Kolhe, Tanguy Lafont, Mark Lambie, Sarah Lawman, Thomas Ledson, Liz Lightstone, Bethany Lucas, Viyaasan Mahalingasivam, Patrick Mark, Stephen Mcadoo, Kieran Mccafferty, Jean Patrick, Narayan Prasad, Nicholas Pritchard, Francesco Rainone, Raja Ramachandran, Vinay Rathore, Manisha Sahay, Alan Salama, Sanjiv Saxena, Sapna Shah, Claire Sharpe, Sebastian Spencer, Jo Taylor, Patrick Trotter, Udaya Udayaraj, Shiva Ugni, Josh Wade, Mona Wahba, James Wason, Martin Wilkie, Ian Wilkinson
BMC Infectious Diseases, doi:10.1186/s12879-025-10584-4
Purpose Despite vaccination, many patients remain vulnerable to COVID-19 infection and poorer outcomes, because of underlying health conditions resulting in sub-optimal vaccine responses. This study aims to demonstrate whether intranasal niclosamide confers additional protection against COVID-19 infection above standard preventative measures including vaccination. Methods PROTECT-V (PROphylaxis for paTiEnts at risk of COVID-19 infecTion) is a platform trial testing multiple pre-exposure COVID-19 prophylactic agents in vulnerable patients. This paper reports results from the randomised, double blind, placebo controlled intranasal niclosamide arm. 1651 adult patients on dialysis, with a kidney transplant or renal autoimmune conditions on immunosuppression were randomised from 48 sites (37 UK; 11 Indian). Intranasal niclosamide or matched placebo was administered twice daily, for up to nine months. Primary outcome was time to symptomatic COVID-19 infection. Results 1651 patients were randomised (826 niclosamide;825 placebo) between February 2021 to November 2022. 655(39.7%) were dialysis patients, 622(37.7%) kidney transplant recipients and 374(22.7%) had renal autoimmune disease. 97.5% patients in the UK and 66.4% patients in India with comparable proportions in both treatment groups had received COVID-19 vaccinations. Despite no adverse safety signal, there was a high withdrawal rate (40% niclosamide;23.8% placebo) due to local upper airway irritation leading to a significantly shorter treatment duration in the niclosamide group). Symptomatic COVID-19 infection during study treatment was observed in 103 patients in the niclosamide group and 133 in the placebo group (estimated hazard ratio 1.02(95%CI 0.79-1.32)).
Conclusion Intranasal niclosamide did not reduce risk of symptomatic COVID-19 infection in this cohort compared to placebo.
Supplementary Information The online version contains supplementary material available at https:// doi . org/ 10. 1186/ s12879-025-10584-4. Supplementary Material 1. Table S1 . Effect of baseline covariates on development of symptomatic COVID-19 infection. Table S2 : Severity of COVID-19 infection during treatment according to adapted WHO ordinal scale. Table S3 . Proportion of patient reporting moderate symptoms, whilst receiving treatment, at any time point from starting treatment. Table S4 . Serious adverse events reported during the trial in subjects who received at least one dose of Investigational Medicinal Product (IMP). SOC-System Organ Class; PT -Preferred Term. Figure S1 . Kaplan-Meier plots on time on trial treatment without confirmed symptomatic COVID-19 infection by treatment allocation. Figure S2 . Forest plot of time to confirmed symptomatic COVID-19 infection by baseline characteristics. p value of the associated interaction with the treatment allocation is presented next to each of the subgroup headings.
Role of the funding source The PROTECT-V study was funded by LifeArc, Addenbrooke's Charitable Trust and Kidney Research UK. Intranasal niclosamide (UNI911) and additional funding for the niclosamide arm, both in the UK and India, was provided by UNION therapeutics A/S. This was an academic initiated study, and decisions regarding the design, conduct and reporting of the study rested with the study team and sponsors (Cambridge University Hospitals..
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doi:10.1097/TP.0000000000004462DOI record:
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"abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Purpose</jats:title>\n <jats:p>Despite vaccination, many patients remain vulnerable to COVID-19 infection and poorer outcomes, because of underlying health conditions resulting in sub-optimal vaccine responses. This study aims to demonstrate whether intranasal niclosamide confers additional protection against COVID-19 infection above standard preventative measures including vaccination.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>PROTECT-V (PROphylaxis for paTiEnts at risk of COVID-19 infecTion) is a platform trial testing multiple pre-exposure COVID-19 prophylactic agents in vulnerable patients. This paper reports results from the randomised, double blind, placebo controlled intranasal niclosamide arm.</jats:p>\n <jats:p>1651 adult patients on dialysis, with a kidney transplant or renal autoimmune conditions on immunosuppression were randomised from 48 sites (37 UK; 11 Indian). Intranasal niclosamide or matched placebo was administered twice daily, for up to nine months. Primary outcome was time to symptomatic COVID-19 infection.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>1651 patients were randomised (826 niclosamide;825 placebo) between February 2021 to November 2022. 655(39.7%) were dialysis patients, 622(37.7%) kidney transplant recipients and 374(22.7%) had renal autoimmune disease. 97.5% patients in the UK and 66.4% patients in India with comparable proportions in both treatment groups had received COVID-19 vaccinations. Despite no adverse safety signal, there was a high withdrawal rate (40% niclosamide;23.8% placebo) due to local upper airway irritation leading to a significantly shorter treatment duration in the niclosamide group). Symptomatic COVID-19 infection during study treatment was observed in 103 patients in the niclosamide group and 133 in the placebo group (estimated hazard ratio 1.02(95%CI 0.79–1.32)).</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusion</jats:title>\n <jats:p>Intranasal niclosamide did not reduce risk of symptomatic COVID-19 infection in this cohort compared to placebo.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Trial Registration</jats:title>\n <jats:p>This study is registered with ClinicalTrials.gov: NCT04870333 (submitted 01/03/2021; posted 03/05/2021), EudraCT: 2020–004144-28 and the Clinical Trials Registry of India (CTRI):#CTRI/2022/03/040802.</jats:p>\n </jats:sec>",
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"value": "All authors have completed the Unified Competing Interest Form (available on request from the corresponding author) and declare the following: MCX has received PhD funding support from GlaxoSmithKline. ID has research grants from Sanofi, Baxter and NIHR CRN West Midlands; honoraria from GSK, Sanofi, Vifor and AstraZeneca; support to attend meetings from GlaxoSmithKline; and sits on DSMB/advisory boards for GlaxoSmithKline and Vifor. DD has received research grants from GlaxoSmithKline; sites on DSMB/advisory boards for Gilead Sciences Inc and Synairgen Plc and since May 2023 is an employee of AstraZeneca. MJ, PS and AWC are employees of Union therapeutics A/S. MLJ is an employee of Union therapeutics A/S and sits on the advisory board for Radiometer and board of directors for HEDIA. MAOS is a co-founder and shareholder at Union therapeutics A/S and a co-inventor on patents and patent applications around the use of niclosamide to treat COVID-19. VJ has received consulting fees from GlaxoSmithKline, Boehringer Ingelheim, Bayer, Vera, Visterra, Biocryst, AstraZeneca; honoraria from Baxter Healthcare and GlaxoSmithKline; and sits on DSMB/advisory boards for Zydus Lifesciences. TFH is and employee and shareholder at GlaxoSmithKline and is an ICH E20 working Group Member. RMS has received research grants from LifeArc, Kidney Research UK, Addenbrooke’s Charitable Trust, Union therapeutics A/S and GlaxoSmithKline for the PROTECT-V trial. TJLH, WQ, FD, RA, TH, LS, AB, NB, JRB have no conflicts of interest to declare."
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