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Abstract: FR-PO005

Prophylaxis for Vulnerable Patients at Risk of COVID-19 Infection (PROTECT-V): A Platform Trial Experience

Session Information

Category: Coronavirus (COVID-19)

  • 000 Coronavirus (COVID-19)

Authors

  • Smith, Rona M., University of Cambridge, Cambridge, Cambridgeshire, United Kingdom
  • Qian, Wendi, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
  • Dosanjh, Davinder P S, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom
  • Dowling, Francis, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
  • Gatley, Katrina L., Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
  • Yilmaz, Zehra, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
  • Jha, Vivekanand, The George Institute for Global Health, New Delhi, India
  • Humphrey, Toby Jl, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
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 COVID-19 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 COVID-19 infection, and each agent will be independently evaluated in real time when the required number of events occur.

Results

The trial commenced with the first intervention, intranasal niclosamide (UNI911) and matched placebo (1:1 ratio) in February 2021. As of 14th May, 1175 patients from 36 UK sites and 6 Indian sites had been enrolled. A second inhaled intervention, ciclesonide with matched placebo, will be added to the platform in the UK imminently. In parallel to the repurposed drug arms, a monoclonal antibody arm, sotrovimab, will enrol vaccine non-responders in a 1:1 ratio, active: placebo in the UK.

Conclusion

The PROTECT-V trial platform brings greater efficiency, running multiple sub-trials within one master protocol. It is an exemplar trial demonstrating the success of collaboration in the COVID-19 pandemic. The platform is jointly funded from charitable (LifeArc, Kidney Research UK, Addenbrooke’s Charitable Trust), government (NIHR), and industry (Union Therapeutics (Hellerup, Denmark) for the niclosamide arm; Vir/GSK for the sotrovimab arm) sources and focuses on patient populations often excluded from clinical trials due to complex disease, but remain vulnerable to infection despite the success of vaccination.
The trial is sponsored by Cambridge University Hospitals NHS Foundation Trust and University of Cambridge in the UK, and The George Institute for Global Health in India.
Clinicaltrials.gov: NCT04870333; EudraCT: 2020-004144-28.

Funding

  • Commercial Support