PROTECT-V is an international, multicentre study aiming to identify medications which protect vulnerable patients from COVID-19. The trial is enrolling patients who are at particularly high risk of COVID-19 and its complications. These are vulnerable populations who are underrepresented in many existing clinical trials.
Immunocompromised patients are particularly vulnerable to COVID19 as they are not able to fight the infection as well as others. Whilst we now have vaccines against COVID19, vaccines do not work for everyone. In particular, those that have an immune system that doesn’t work normally, or that take medicines which suppress the immune system, may not get as good protection from vaccines.
The research team are currently recruiting Transplant and Primary Immunocompromised patients to the Sotrovimab arm of PROTECT-V. 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 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.
Patients 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 (double blinded randomized controlled trial).
Patients are invited to attend a screening visit to assess eligibility and then a dosing visit within 2 weeks where they will receive either a 2mg dose of Sotrovimab over 30 minutes, or a placebo infusion.
After infusion, patients are followed up by a series of face to face and telephone follow up visits for 11 months. The primary end point for the study is COVID-19 infection and therefore if a patient were to test positive while on the study, a homecare visit is arranged to take research bloods within 3 days of confirmed infection and they are invited to attend Papworth for another research visit 28 days after confirmed infection.
Patient take up of the study has generally been good as COVID-19 is still a real danger for our most vulnerable patients. 12 patients have been randomised and had their infusions so far with lots more patients keen to attend screening visits. We see our patients in the new HLRI CRF, so it has been great showing patients our new facilities. Dr Parmar, Dr Baxendale and the team will be screening and recruiting patients until at least December 2023, however the study is likely to be extended into next year.
The PROTECT V team - Jenny Mackie, Kitty Paques, Dr J S Parmar and Allison Doel
