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other·infectious disease, immunology, nephrology, oncology, clinical trial·PMC10009350

PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V)

Trials · 11 authors, 7 centres

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TL;DR

PROTECT-V is a protocol for a multicentre platform randomised controlled trial evaluating pre-exposure prophylactic agents—intranasal niclosamide, nasal and inhaled ciclesonide, and intravenous sotrovimab—against SARS-CoV-2 infection in immunocompromised and vulnerable patient populations.

Full summary

391 CHARS

PROTECT-V is a platform trial protocol evaluating multiple pre-exposure prophylactic agents against SARS-CoV-2 in immunocompromised populations who have suboptimal vaccine responses. The trial employs a shared placebo design across multiple treatment arms (niclosamide, ciclesonide, sotrovimab) and multiple vulnerable populations, allowing independent evaluation of each agent in real time.

STUDY TYPE

other

SPECIALTY

infectious disease

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10009350

PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V)

Trials

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ABSTRACT

Background Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to SARS-CoV-2 infection by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. Methods PROTECT-V is a platform trial testing pre-exposure prophylactic interventions against SARS-CoV-2 infection in vulnerable patient populations (organ transplant recipients; individuals with oncological/haematological diagnoses, immune deficiency or autoimmune diseases requiring immunosuppression or on dialysis). Multiple agents can be evaluated across multiple vulnerable populations sharing placebo groups, with the option of adding additional treatments at later time points as these become available. The primary endpoint is symptomatic SARS-CoV-2 infection, and each agent will be independently evaluated in real time when the required number of events occurs. Presently, three agents are approved in the platform: intranasal niclosamide, nasal and inhaled ciclesonide and intravenous sotrovimab. Discussion Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to COVID-19 disease by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. Trial registration ClinicalTrials.gov NCT04870333 . EudraCT 2020-004144-28

CITATION EXPORT

Toby J. L. Humphrey, Davinder Dosanjh, Thomas F. Hiemstra et al.. PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V). Trials. (2023). https://doi.org/10.1186/s13063-023-07128-z

AUTHORS

11 · 7 CENTRES

Toby J. L. Humphrey, Davinder Dosanjh, Thomas F. Hiemstra, Alex Richter, Michael Chen-Xu, Wendi Qian, Vivekanand Jha, Katrina Gatley, Rakshya Adhikari, Francis Dowling, Rona M. Smith

1grid.24029.3d0000 0004 0383 8386Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
2grid.5335.00000000121885934University of Cambridge, Cambridge, UK
3grid.412563.70000 0004 0376 6589Birmingham and West Midlands Lung Research Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
4grid.6572.60000 0004 1936 7486Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK
5grid.464831.c0000 0004 8496 8261George Institute for Global Health, New Delhi, India
6grid.7445.20000 0001 2113 8111School of Public Health, Imperial College, London, UK
7grid.411639.80000 0001 0571 5193Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India