PROTECT-V

PROTECT-V is an international, multicentre study aiming to identify medications which protect vulnerable patients from COVID-19. The trial is enrolling participants who are at particularly high risk of COVID-19 and its complications. We are recruiting individuals who are immunocompromised for any reason be that primary or secondary immunodeficiency.  These are vulnerable populations who are underrepresented in many existing clinical trials. The study opened to recruitment in February 2021 and is designed to allow us to evaluate several different drugs at the same time. At the moment we are evaluating the safety and efficacy of two medications; intravenous Sotrovimab and intranasal Niclosamide.

• Sotrovimab - is a fully human IgG1κ monoclonal antibody (mAb) derived from the parental mAb S309, a potent neutralising mAb directed against the spike protein of SARS-CoV-2. Sotrovimab is delivered as a single, one-off, intravenous infusion. It is currently being used for the early treatment of those with COVID-19 in routine clinical practice, but we do not yet know whether it can prevent infection. We are actively recruiting to this arm of the trial; participants are randomly assigned to either receive treatment with sotrovimab or placebo and neither the patient nor the trial investigators will know which treatment a patient has been assigned to. For more information, please see the ‘Patients’ tab of the website. If you are a member of staff from a site that may want to open the Sotrovimab arm of PROTECT V, please see the 'staff' tab and  get in touch with our trials manager below.
• Niclosamide– a medication routinely used to treat tapeworm infections, which has demonstrated in vitro action against SARS-CoV2. It is hypothesised that this will disrupt SARS-CoV2 replication and penetration into cells. Niclosamide is typically taken as an oral tablet but PROTECT-V will use a stable liquid formulation (UNI911) via a nasal spray in order to maximise the effect in the nasal lining where SARS-CoV2 initially predominantly replicates. The Niclosamide arm of the trial has now completed recruitment having recruited 1653 patients.  The data is currently being analysed and initial results are due soon!