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

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 occur. 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.