PROTECT-V

PROphylaxis for paTiEnts at risk of COVID-19 infecTion

The PROTECT-V trial will enrol patients at particularly high risk of COVID-19 and its complications.  The first drug to be tested to see if it might prevent the disease from occurring is intranasal niclosamide.  This arm opened to recruitment in February 2021.  The niclosamide arm of PROTECT-V will enrol patients with kidney or autoimmune diseases, including patients undergoing dialysis, kidney transplant recipients, and individuals with auto-immune conditions receiving immunosuppression.  These are vulnerable populations who are underrepresented in many existing clinical trials.

• 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. Patients will be randomly assigned to either receive treatment with Niclosamide or placebo and neither the patient nor the trial investigators will know which treatment a patient has been assigned to. In August 2022, the second agent sotrovimab has been added to the platform. This expands the populations being enrolled to include other at-risk groups who have mounted sub-optimal vaccine responses including patients receiving chemotherapy, transplant recipients and those that are immunosuppressed due to a variety of underlying conditions or treatments.
• 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 infusion. Patients will be 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.

Welcome to the patient area for the PROTECT-V trial website. This trial aims to enrol patients at particularly high risk of COVID-19 and its complications, seeking to test whether intranasal niclosamide might prevent the disease from occurring.

The following provides answers to questions you might have about this trial:

Patient Information Sheet and Informed Consent Form (Niclosamide)

Patient Information Sheet and Informed Consent Form (Sotrovimab)

Welcome to the staff area for the PROTECT trial. Patients on dialysis or receiving immunosuppressive medications may be invited to take part in this trial.

Protocol

Trial Protocol

FAQs

PROTECT-V FAQs

Information coming soon.

Trial Steering Committee (TSC)

Independent Chair: Dr Rupert Beale

Chief Investigator: Dr Rona Smith

 

Members of the Trial Management Group: Dr Wendi Qian (Trial Statistician), Dr Lynne Whitehead (Trial Pharmacist), Daniel Alvarez-Berdugo (Trial Coordinator) and Rakshya Adhikari (Data Manager)

 

Independent Clinician(s) or Scientist(s): Dr Laurie Tomlinson and Dr Charles Ferro

 

Principal Investigators: TBC

 

Independent Statistician: Dr Sofia Villar

 

Non-voting Funder Representative: TBC

 

Sponsor Representative: Mrs Carrie Bayliss

Data Monitoring Committee (DMC)

Chair: Prof Graham Cooke (Imperial College, London, UK)

Other Committee Members: Dr Michael Walsh (Hamilton, Canada) and Dr Mark Glover (Nottingham, UK)

Statistician: Dr Daniel Slade (Birmingham, UK)