2021_034: PROphylaxis for paTiEnts at risk of Covid-19 infecTion (PROTECT): a basket trial of prophylactic interventions amongst at-risk patients
PROTECT-V is testing a number of medications to see if they help protect against COVID-19 infection.
About the project:
What the project aims to do
PROTECT-V is a platform trial to test treatments to prevent patients from getting COVID-19 infection. A ‘platform trial’ is a clinical trial with a master protocol, which allows for multiple treatments to enter or exit the trial over the course of the study. PROTECT-V is testing a number of medications to see if they help protect against COVID-19 infection. The focus of this trial is on prevention of disease, rather than treatment once disease occurs. This will be measured by comparing if COVID-19 develops in people who take the trial treatment against those who receive a placebo treatment.
Why this project is important
There is an urgent need for medicines that can prevent COVID-19 infection. There has been a large effort to create vaccines against COVID-19, but unfortunately, vaccines do not work for everyone. In particular, those that have an immune system that doesn’t work normally, or who take medicines which suppress the immune system, may not get as good protection from vaccines. These patients remain vulnerable to COVID-19 infection, and are at greater risk of being hospitalised and having poorer outcomes.
PROTECT-V is the only platform study in the UK specifically studying pre-exposure prophylaxis in COVID-19 infection.
The PROTECT-V trial has already recruited 1,653 patients to the first arm of the study, using a nasal spray of a medication called niclosamide. Niclosamide, a common, safe drug that has been used in tablet form for tapeworm infections for decades. Preliminary research has shown it may also help protect against COVID-19 infection. However, niclosamide tablets are poorly absorbed from the gut into the bloodstream. Therefore, in the PROTECT-V trial, niclosamide will be administered by a nasal spray directly to the lining of the nose, which is where the virus that causes COVID-19 infection usually first takes hold.
The drug being tested in the trial is called Sotrovimab. It is a monoclonal antibody which is designed to block COVID-19 virus particles from binding to the cells of the body. Research using this drug so far has suggested that people with COVID-19 infection who are given this treatment early on are less likely to develop severe disease. It is hoped that the medicine will protect people from COVID-19 if they have had a poor response to a vaccine.
Being a platform study, there is the possibility to add further promising agents in the future.
Who the data is about
Participants enrolled in the PROTECT trial with extant consent.
How the data will be used
The study will recruit people that are in a vulnerable patient population and at a high risk of getting COVID-19, who often have worse complications if they get COVID-19 infection. Vulnerable patient groups include the following:
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individuals receiving dialysis treatment
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individuals with an immunodeficiency (primary or secondary)
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individuals with 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 the disease or treatment
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individuals with a diagnosis of an autoimmune or inflammatory disease and are currently receiving immunosuppression
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individuals with a solid organ or haematopoietic stem cell transplant
UKHSA COVID-19 infection data will be collected under consent and will be provided on a monthly basis.
The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are joint research sponsors. All data will be stored by the University of Cambridge only and all data processing will only occur within the University of Cambridge network. Identifiable data will be stored, processed and linked in the SDHS (Secure Data Hosting Service), which can only be accessed on a strict permission basis. Only the database programmer, coordinator and data manager have access to data in the SDHS.
The UKHSA data will be used to confirm the primary endpoint of the trial – symptomatic COVID-19 infection. The symptoms that a patient experiences will be recorded in the electronic case record form.
How often data is needed
Annual release.
How this project will benefit public health and the public
Although vaccines are now available, sub-optimal vaccine response and vulnerability to COVID-19 infection remains a major issue in clinically extremely vulnerable individuals, including the immunocompromised. There remains a need for other prophylactic agents for individuals who do not respond to vaccines either due to their underlying health condition or medications that they must receive. There is a significant potential benefit to the public health and the public good from the PROTECT-V research. The expected impact of this trial would be informing UK health professionals of appropriate prophylaxis medication that could be used for individuals who mount sub-optimal responses to vaccines.
Planned project outputs and communication
- peer-reviewed scientific journals
- internal report (publication not intended)
- conference presentation
- website
- press release
- EU Clinical Trials Register website, a central registry for all clinical trials conducted in the EU.
- regulatory authorities for licensing purposes
Lawful processing of personal and special category personal data
Under the UK General Data Protection Regulation (GDPR), the data required for this project is classified as special category personal data. This means that, in order for the processing of this data to be lawful, there must be both a lawful basis for processing under Article 6 and a separate condition for processing under Article 9 of the UK GDPR.
Legal basis for using personal data (Article 6)
UK GDPR Article 6(e): processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Controller.
Legal basis for using special category personal data (Article 9)
UK GDPR Article 9(2)(j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
Common law duty of confidentiality
The data needed for this project includes Confidential Patient Information — meaning data that can both identify an individual and relate to their health or care, shared in a context where confidentiality is expected and protected.
Confidential Patient Information is subject to a strict duty of confidentiality. It can only be used with the patient’s explicit consent or under specific legal provisions that permit its use — for example, for medical research or public health purposes.
How is the duty of confidentiality set aside
Explicit informed consent.
National Data Opt-Out
Opt-out preferences will not be applied.
This is because the national data opt-out does not apply to anonymised data.
Digital Object Identifier:
Not assigned to this release.