PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V).
Author
Humphrey, Toby J LDosanjh, Davinder
Hiemstra, Thomas F
Richter, Alex
Chen-Xu, Michael
Qian, Wendi
Jha, Vivekanand
Gatley, Katrina
Adhikari, Rakshya
Dowling, Francis
Smith, Rona M
Publication date
2023-03-13
Metadata
Show full item recordAbstract
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
Humphrey TJL, Dosanjh D, Hiemstra TF, Richter A, Chen-Xu M, Qian W, Jha V, Gatley K, Adhikari R, Dowling F, Smith RM. PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V). Trials. 2023 Mar 13;24(1):185. doi: 10.1186/s13063-023-07128-zType
ArticleAdditional Links
https://trialsjournal.biomedcentral.com/PMID
36915199Journal
TrialsPublisher
BMCae974a485f413a2113503eed53cd6c53
10.1186/s13063-023-07128-z