PROTECT-V

PROphylaxis for paTiEnts at risk of COVID-19 infecTion

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!

Welcome to the patient area of the PROTECT-V trial website. This trial aims to enrol patients at particularly high risk of COVID-19 and its complications, and we are looking for drugs which might prevent the disease.

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. This is why it is important we find medications that can protect those where vaccines are less effective.

We are recruiting patients from all over Great Britain who are immunocompromised; including but not limited to those in the following groups:

• Those receiving dialysis treatment 
• Those with a primary immunodeficiency 
• Those who have an Oncology (cancer), Haemato-Oncology (blood cancer) or Haematology (blood disorder) diagnosis, and have received chemotherapy or have a weakened immune system as a result of your disease or treatment 
• Those who have a diagnosis of an autoimmune/inflammatory disease and are currently receiving immunosuppression (Prednisolone ≥20mg daily for at least 4 consecutive weeks is considered a form of immunosuppression in this study)
• Those who have received a solid organ or haematopoietic stem cell transplant 

Currently we are recruiting to the Sotrovimab arm of PROTECT-V. This is a medicine currently used for the treatment of SARS-CoV-2 infection. PROTECT-V is assessing its ability to prevent COVID19 disease. You can download the full information sheet here.

The following sites (and lead Investigator) are currently actively recruiting participants to the Sotrovimab arm of PROTECT-V:

Addenbrooke's Hospital, Dr Effrossyni Gkrania-Klotsas
QE Hospital, B'Ham, Dr Ben Sutton
Heartlands Hospital Group, Prof Indranil Dasgupta
Royal Devon & Exeter, Dr Coralie Bingham
Royal Liverpool, Dr Richard Fitzgerald
King's College Hospital, Dr Jonathan Dick
Royal Derby Hopital, Dr Nitin Kolhe
St James Hospital, Leeds, Dr Sunil Daga
James Cook Hospital, Dr John Widdrington (closed to recruitment)
Portsmouth Hospital, Dr Alex Hicks
Peterborough City Hospital, Dr Abigail Hollingdale
Hinchingbrooke Hospital, Dr Cheryl Palmer
Royal Papworth, Dr Jasvir Parmar
West Suffolk Hospital, Dr William Petchey (closed to recruitment)
Royal Brompton Hospital, Prof Philip Molyneaux
Harefield Hospital, Dr Vicky Gerovasili
North Manchester General Hospital, Dr Silke Brix 
Lister Hospital, Dr Sarah Fluck
Monklands Hospital, Dr Scott Oliver
Hammersmith Hospital, Dr Stephen McAdoo
Derriford Hospital, Dr Lucy Leeman
Ninewells Hospital, Dr Samira Bell
Royal Free Hospital, Dr Sorena Kiani
Queeens Medical Centre, Dr Hiba Mohamad
Sheffield North General Hospital, Dr Ragada El-Damanawi

Check back on our website to see updated lists of sites that are open or due to open soon.

Welcome to the staff area for the PROTECT trial.

We are still looking for new sites! If you are interested in becoming a new PROTECT-V site, or if you are an existing site that wishes to open the Sotrovimab arm, please download and complete our feasibility form and return it to add-tr.protect@nhs.net.  If you need any further information about the study or would like some help/guidance with completion of the feasibility form, please do not hesitate to contact us via add-tr.protect@nhs.net or by contacting one of the Chief Investigator directly.

Protocol

Trial Protocol

FAQs

TBC

Please find links below to training information and publications as they are made publically available.

Training Slides

The following slides are very similar, the only difference relates to whether some of the trial research samples are sent to Cambridge (Group 1) or Birmingham (Group 2).

SIV slides sotrovimab v6.1 19.10.2023 Group 1

SIV slides sotrovimab v7.1 19.10.2023 Group 2

Publications

Protocol Paper, please find the open access here, with the link to the BMC site here.

Niclosamide results are out and the PROTECT-V trial continues "PROTECT-V study stepped up in fight against COVID" 12th June 2023

Trial Steering Committee (TSC)

Trial Steering Committee
Independent Chair: Dr Rupert Beale - Consultant Nephrologist 

Independent Clinician(s): 
Dr Laurie Tomlinson - Consultant Nephrologist and Epidemiologist
Dr Charles Ferro - Consultant Nephrologist
Prof Richard Haynes - Professor of Renal Medicine and Clinical Trials
Dr Matthias Schmid - Consultant in Infectious Diseases
 
Independent Statistician: Dr Sofia Villar

Chief Investigator: Dr Rona Smith

Members of the Trial Management Group: 
Dr Wendi Qian (Trial Statistician)
Dr Rachel Donegan (Trial Statistician)
Dr Robyn Staples (Trial Pharmacist)
Mr Francis Dowling (Trial Manager)
Mrs Phoebe Vargas (Trial Coordinator)
Mr Emmanuel Sappor (Trial Coordinator)
Ms Lindsay Carr (Trial Coordinator)
Mr Aamir Iqbal (Trial Coordinator)
Mrs Rakshya Adhikari (Data Manager/Programmer)
Mr Alongir Miah (Data Manager)
Mr Peter Price (Data Manager)

Sponsor Representative(s): Mrs Carrie Baylis, Dr Ella James

Non-voting Funder Representative: Jennifer Han (GSK)
 

Data Monitoring Committee (DMC)

Independent Chair: Prof Graham Cooke - Professor of Infectious Diseases

Independent Clinician(s): 
Dr Michael Walsh - Consultant Nephrologist and Clinical trialist
Prof Maya Buch - Consultant Rheumatologist
Dr Francesca Kinsell - Consultant Haematologist

Independent Statistician: Dr Victoria Homer