Background

Several patient groups remain vulnerable to SARS-CoV-2 infection due to suboptimal vaccine responses and may benefit from pre-exposure prophylaxis. PROTECT-V is a platform trial evaluating pre-exposure prophylactic interventions against SARS-CoV-2 in vulnerable patient populations (NCT04870333).

Methods

The monoclonal antibody sotrovimab (2g intravenous dose) and matched placebo is the latest intervention added to the PROTECT-V trial in vulnerable patient populations: transplant recipients; individuals with oncology-haematology diagnoses, immune deficiency, or autoimmune diseases on immunosuppression or dialysis. The primary endpoint is symptomatic SARS-CoV-2 infection at 12 weeks.

Results

Enrolment began in August 2022; as of 31 January 2023, 242 patients from 12 UK sites have been screened and 119 participants randomised. Eligible participants are 57% female with a median age of 64 (IQR 52?72) years, with a majority of renal (41%) or autoimmune disease (32%) patients.

Discussion

Effective prophylactic interventions against SARS-CoV-2 will protect vulnerable patients with suboptimal vaccine responses and improve their quality of life. The PROTECT-V platform is jointly funded from charitable (LifeArc, Kidney Research UK, Addenbrooke?s Charitable Trust), government (NIHR), and industry (GSK/Vir for the sotrovimab arm) sources and focuses on patient groups often excluded from clinical trials but remain vulnerable to SARS-CoV-2 infection despite successful vaccination. It is planned to recruit a minimum of 1760 participants to the sotrovimab arm.