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Purpose <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.</p> Methods <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.</p> <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.</p> Results <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)).</p> Conclusion <p>Intranasal niclosamide did not reduce risk of symptomatic COVID-19 infection in this cohort compared to placebo.</p> Trial Registration <p>This study is registered with&#xa0;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.</p>

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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

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  • 发表日期：

    2025年2月11日

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  • 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

摘要

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.