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, Toby J L Qian, Wendi Chen-Xu, Michael Dowling, Francis Gatley, Katrina Adhikari, Rakshya Hensman, Tracey Stockley, Louise Bassi, Abhinav Bathla, Nikita
Humphrey, Toby J L
Qian, Wendi
Chen-Xu, Michael
Dowling, Francis
Gatley, Katrina
Adhikari, Rakshya
Hensman, Tracey
Stockley, Louise
Bassi, Abhinav
Bathla, Nikita
Affiliation
Cambridge University Hospitals NHS Foundation Trust; University of Cambridge; George Institute for Global Health; University Hospitals Birmingham NHS Foundation Trust; University of Birmingham; UNION Therapeutics A/S; Imperial College London; Technical University of Denmark
Other Contributors
Alchi, Bassam
Alejmi, Abdulfattah
Basu, Neil
Bebb, Charlotte
Bell, Samira
Bhargava, Anudita
Bhandari, Sunil
Bingham, Coralie
Bramham, Kate
Caskey, Fergus
Chand, Sourabh
Chaudhry, Dhruva
Chaudhry, Arpita Ray
Chennamsetty, Sashidhar
Chitalia, Nihil
Chowdhury, Paramit
Curran, Simon
Davies, Simon
Davison, Rachel
Delaney, Michael
Dey, Vishal
Dick, Jonathan
Eid, Mahmoud
El-Damanawi, Ragada
Fluck, Sarah
Gama, Rouvick
Goldsmith, Christopher
Gkrania-Klotsas, Effrossyni
Griffin, Sian
Hull, Richard
Ignatius, Avinash
Jayne, David
Jones, Colin
Kamalnathan, Manivarma
Kolhe, Nitin
Lafont, Tanguy
Lambie, Mark
Lawman, Sarah
Ledson, Thomas
Lighstone, Liz
Lucas, Bethany
Mahalingasivam, Viyaasan
Mark, Patrick
McAdoo, Stephen
McCafferty, Kieran
Patrick, Jean
Prasad, Narayan
Pritchard, Nicholas
Rainone, Francesco
Ramachandran, Raja
Rathore, Vinay
Sahay, Manisha
Salama, Alan
Saxena, Sanjiv
Shah, Sapna
Sharpe, Claire
Spencer, Sebastian
Taylor, Jo
Trotter, Patrick
Udayaraj, Udaya
Ugni, Shiva
Wade, Josh
Wahba, Mona
Wason, James
Wilkie, Martin
Wilkinson, Ian
Alejmi, Abdulfattah
Basu, Neil
Bebb, Charlotte
Bell, Samira
Bhargava, Anudita
Bhandari, Sunil
Bingham, Coralie
Bramham, Kate
Caskey, Fergus
Chand, Sourabh
Chaudhry, Dhruva
Chaudhry, Arpita Ray
Chennamsetty, Sashidhar
Chitalia, Nihil
Chowdhury, Paramit
Curran, Simon
Davies, Simon
Davison, Rachel
Delaney, Michael
Dey, Vishal
Dick, Jonathan
Eid, Mahmoud
El-Damanawi, Ragada
Fluck, Sarah
Gama, Rouvick
Goldsmith, Christopher
Gkrania-Klotsas, Effrossyni
Griffin, Sian
Hull, Richard
Ignatius, Avinash
Jayne, David
Jones, Colin
Kamalnathan, Manivarma
Kolhe, Nitin
Lafont, Tanguy
Lambie, Mark
Lawman, Sarah
Ledson, Thomas
Lighstone, Liz
Lucas, Bethany
Mahalingasivam, Viyaasan
Mark, Patrick
McAdoo, Stephen
McCafferty, Kieran
Patrick, Jean
Prasad, Narayan
Pritchard, Nicholas
Rainone, Francesco
Ramachandran, Raja
Rathore, Vinay
Sahay, Manisha
Salama, Alan
Saxena, Sanjiv
Shah, Sapna
Sharpe, Claire
Spencer, Sebastian
Taylor, Jo
Trotter, Patrick
Udayaraj, Udaya
Ugni, Shiva
Wade, Josh
Wahba, Mona
Wason, James
Wilkie, Martin
Wilkinson, Ian
Publication date
2025-02-11
Collections
Research Projects
Organizational Units
Journal Issue
Abstract
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.
Citation
Humphrey TJL, Qian W, Chen-Xu M, Dowling F, Gatley K, Adhikari R, Hensman T, Stockley L, Bassi A, Bathla N, Dasgupta I, Dosanjh DPS, Jellingsø M, Sørensen P, Jensen ML, Callesen AW, Bradley JR, Jha V, Sommer MOA, Hiemstra TF, Smith RM; PROTECT-V consortium. 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. BMC Infect Dis. 2025 Feb 11;25(1):204. doi: 10.1186/s12879-025-10584-4.
Type
Article