TY - JOUR
AU - Humphrey, Toby J. L.
AU - Qian, Wendi
AU - Chen-Xu, Michael
AU - Dowling, Francis
AU - Gatley, Katrina
AU - Adhikari, Rakshya
AU - Hensman, Tracey
AU - Stockley, Louise
AU - Bassi, Abhinav
AU - Bathla, Nikita
AU - Dasgupta, Indranil
AU - Davinder P. S., Dosanjh
AU - Jellingsø, Mads
AU - Sørensen, Per
AU - Jensen, Morten Lind
AU - Callesen, Anne Weibel
AU - Bradley, John R.
AU - Jha, Vivekanand
AU - Sommer, Morten O. A.
AU - Hiemstra, Thomas F.
AU - Smith, Rona M
AU - PROTECT-V Consortium
AU - Basu, Neil
AU - Dey, Vishal
AU - Mark, Patrick B.
PY - 2025
DA - December
TI - 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
JO - BMC Infectious Diseases
VL - 25
DO - https://doi.org/10.1186/s12879-025-10584-4
AB - 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. Trial Registration: 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.
PB - BioMed Central
UR - https://eprints.gla.ac.uk/376684/
KW - Coronavirus (COVID-19)
ER