VIR-7831/7832
Your doctors suspect that you have a lung disease called COVID-19. This condition is caused by a type of virus called SARS-CoV-2, or coronavirus for short.
At the moment, there are no treatments proven to work against COVID-19 for patients with mild to moderate symptoms, although there are several which may turn out to be helpful when added to the usual standard of care. This study aims to find out whether any of these additional treatments are of any help.
This is the first time study drug VIR-7832 is being given to people with COVID-19.
The study drug has not yet been tested in humans; however, it has been tested extensively in animals. A full description of the risks associated with the study drug is provided in Section 11 of this document.
The AGILE study aims to assess several different treatments that may be useful for patients with COVID-19. These treatments have been recommended for testing by a team of experts (The AGILE Scientific Advisory Board) based on strict criteria.
The aims of this study are to determine, in people with COVID-19, the following:
- The safety of the study drugs and any side effects that might be associated with it
- How much of the study drugs get into the bloodstream
- How quickly the body removes the study drugs
- How well the study drugs might be able to reduce complications of COVID-19
- How the study drug affects the body’s response to COVID-19
Although these treatments show promise, nobody knows if any of them will turn out to be more effective in helping patients recover than the standard of care at home as recommended by their doctor (which all patients currently receive).
The treatment being assessed in this study is VIR-7832.
At present, we do not know whether VIR-7832 is safe when given to people. This is a first in human trial. We have safety information from a study done with a highly similar drug called VIR-7831. VIR-7831 has been tested on 20 patients with mild to moderate COVID-19 disease and was found to be safe in these patients. VIR-7832 is almost identical to VIR-7831 except that VIR-7832 has been modified slightly to increase its ability to stimulate the immune system.
The AGILE Candidate-Specific Trial-5 VIR-7831 and VIR-7832 is being done in two parts – phase I and phase II.
You are being invited to take part in Phase I.
Phase I: First, we need to establish at what dose VIR-7832 is safe when given to patients with mild to moderate disease (patients with COVID-19 who do not need to go to hospital). A small group of patients will participate in the phase I component of the study where they will receive different doses of VIR-7832 dependent on what dose group (cohort) they are in. The doses chosen are based on the study of nearly identical drug VIR-7831 mentioned above.
Patients will be randomly split into two groups. One group (the control group) will receive placebo (‘dummy’ treatment) plus the standard of care, and the other group (the treatment group) will receive VIR-7832 plus the standard of care, this is called a placebo controlled study, and it is the most reliable way of assessing whether a drug works. Neither you nor your doctor will know which group you are in – which means the trial is ‘double-blinded’.
Taking part in the study is entirely voluntary and if you do not wish to participate this will not affect the standard of care you receive in any way. It is up to you to decide whether or not to take part. If you do decide to take part, you will be given this information sheet to keep and asked to sign a consent form.
If you decide to take part, you are still free to withdraw at any time without giving a reason.
If you do not wish to take part in this study, you will be offered whatever treatment your doctor thinks is best for you.
VIR-7832 is an anti-viral drug, a monoclonal antibody, which is currently being tested as specific treatment for COVID-19. Antibodies are natural proteins in the body that fight infections and monoclonal antibodies are antibodies which are produced in a laboratory from human immune cells. VIR-7832 is thought to work by blocking the COVID-19 virus from entering our body’s cells so it cannot make more of itself.
Both VIR-7832 and the placebo are given as an intravenous (IV) infusion – this means it will be given through a small plastic tube (cannula) placed into a vein in your arm. You will only receive one infusion – on Day 1 of the study at the hospital. The infusion will take about 1 hour.
You will remain at the clinical research unit for at least 24 hours after you receive the infusion for observation.
The study is being conducted by researchers at the University of Southampton and the University of Liverpool. The University of Liverpool is the Sponsor for the research. This means that they have overall responsibility for making sure the research is conducted in accordance with the relevant regulations.
You have been invited to consider taking part in this study because you may meet the criteria for taking part. We first need to ask you some questions; this is called screening. You must answer all the screening questions completely and truthfully. You must mention all past and present medical conditions, including any allergies. You must also mention any medications you are taking currently or have taken recently, including prescription and non-prescription/over-the-counter medications and vitamins/supplements.
To start screening for the study, you must meet the following criteria:
- Aged 18 to 65
- Have one or more COVID-19 symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhoea, shortness of breath on exertion
- Have had COVID-19 symptoms for 7 days or less
You will then undergo screening assessments outlined in section 9.
You must let the research team know about any other clinical studies you have taken part in or are currently taking part in. If you pass the screening assessments, we may invite you to take part in the study. You must be able to comply with all study procedures and attend clinic visits. If you decide to join, you will be asked to sign the consent form.
Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception from the administration of trial treatment and for the next 24 weeks after receiving the trial treatment. Further information is provided in section 13 of this Patient Information Sheet.
The study compares the study drug and the standard of care with placebo and the standard of care. Phase I is designed to test what is a safe and tolerable dose of VIR-7832.
All patients receive an IV infusion of either the study drug or placebo. Patients in the treatment group will be given an IV infusion dose of VIR-7832. The control group will receive an IV infusion of placebo (which is a saline solution). This means that some participants will receive the study drug, and some will not.
Whether you receive study drug will be determined by a process called ‘randomisation’. The randomisation for this phase of the study will be done in a 3:1 ratio. This means that for every 4 patients who enter the study, 3 patients will receive study drug and 1 patient will receive placebo. The only way to make sure that the two groups of patients are as similar as possible is to have your treatment decided by chance. Therefore, neither you nor your doctors can choose which of these options you will be allocated.
If you are in the first dose group (cohort), you will be given 50 mg of VIR-7832. This is a much smaller dose than the highest equivalent dose of VIR-7832 that was tested in animals.
We plan to continue increasing the dose tested in the cohorts up to a dose level that is considered to be safe. The dose levels to be studied in the remaining groups will depend upon the results from the previous groups. Before receiving the study drug, you will be informed of the dose level your assigned group is to receive.
Following treatment, on days 3, 5, 8, 11, 15, 22 and 29 and on weeks 8, 12, 20 and 24 you will return to the hospital and the research team will check if you have had any side effects. You will give some blood samples on these days so the team can test to see if the treatment is having an effect. You will also have a nose and throat swab on days 1, 3, 5, 8, 11, 15, 22 and 29 to check for the amount of COVID-19 virus in your system.
During the study, you will visit the hospital on at least 12 occasions (possibly 13) over a period of approximately 24 weeks. These visits will include the screening visit (lasting approximately 90 minutes), an in-clinic visit to receive the IV infusion of the study drug or placebo and for observation after the infusion (lasting a minimum of 24 hours) and further 11 in-clinic visits (lasting approximately 2 hours each). The specific visits are detailed below.
| Visit 1 | Screening Visit |
|---|---|
| Details | The purpose of the screening visit is to determine if you are eligible and willing to participate in the study.
Before any procedures are performed, we will ask you to sign an Informed Consent Form. The visit will last approximately 90 minutes. |
| Procedures Performed |
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| Additional Information | After your screening visit, the study doctor will review the results of these tests to see whether you are eligible to take part in the study. If you are eligible, we will ask you to return to the clinic within 4 days from your screening visit. |
| Day 1 | In-Clinic Study Visit (Baseline Visit) | |
|---|---|---|
| Details |
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| Procedures Performed |
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| Additional Information | All meals, snacks and drinks will be provided for you during your stay at the Unit.
Telephone calls: Any day that you are not attending clinic you will receive a daily telephone call from the research team to check on your health and well-being. Hospitalisation: If you are admitted to hospital, we will collect some general information about your health. |
| Days 1 to 15 | |
|---|---|
| Remote Oxygen Monitoring (Follow Up) | |
| Details | You will be provided with a remote oxygen monitoring device (that attaches onto your finger) and asked to monitor and document your oxygen levels twice a day at home (including In-Clinic Study Visit days). The research nurses will teach you how to do this. This should only take approximately 5 minutes each day. During the daily phone calls and/or whilst in clinic the nurses will collect the results you have recorded from you. |
| Procedures Performed |
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| Additional Information | If any of your oxygen level results are abnormal, we may ask you to return to the Unit for additional tests or monitoring until they return to normal.
If you withdraw from the study, follow-up assessments may be performed at the time you withdraw. |
| Days 3, 5, 8, 11, 15, 22 and 29 | |
|---|---|
| In-Clinic Study Visit (Follow Up) | |
| Details | Each visit will last approximately 2 hours. |
| Procedures Performed |
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| Additional information | If any of your lab test results are abnormal, we may ask you to return to the Unit for additional blood or urine tests until they return to normal.
If you withdraw from the study, follow-up assessments may be performed at the time you withdraw. |
| Days 2 to 14 apart from In-Clinic Study Visit days | |
|---|---|
| Telephone Calls (Follow Up) | |
| Details | You will be called everyday between days 2-14 (apart from the days on which you are due for an in-clinic study visit). We will ask you the questions in person on those days. Each call will last approximately 5-10 minutes. |
| Procedures Performed |
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| Additional Information | If any of your lab test results are abnormal, we may ask you to return to the Unit for additional blood tests until they return to normal.
If you withdraw from the Study, follow-up asinfsessments may be performed at the time you withdraw. |
| Weeks 8, 12, 20 and 24 | |
|---|---|
| In-Clinic Study Visit (Long Term Follow Up) | |
| Details | Each visit will last approximately 2 hours. |
| Procedures Performed |
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| Additional Information | If any of your lab test results are abnormal, we may ask you to return to the Unit for additional blood or urine tests until they return to normal. If you withdraw from the Study, follow-up assessments may be performed at the time you withdraw. |
During the study, the Research Nurses will collect blood samples on 13 different occasions, through a cannula or needle. A cannula (small plastic tube inserted into a vein in your forearm using a needle) may be used on the days when multiple blood samples need to be taken. A cannula allows bloods to be taken without the need for a needle to be used each time. The maximum total volume of blood taken during the study, including the screening visit, will be no more than 400 mL (a standard blood donation is 450 mL).
We do not know if the treatment being tested will be therapeutic (have a beneficial effect) or help you with your symptoms, but this study should help inform how we treat future patients.
VIR-7832 works by blocking the virus from entering the body’s cells so it cannot make more of itself. VIR-7832 has been extensively tested in monkeys. It was well tolerated in monkeys up to a 600-fold higher dose than the dose being tested in the first dose group (cohort). The results of the animal tests support a recommended starting dose of 50 mg in humans. The study drug has not yet been tested in humans, therefore, there is limited information about its effects and side effects.
VIR-7832 may have side effects that are currently unknown. There is a remote chance that the study drug (like any drug product) may cause an allergic reaction, which in some cases may be severe. This is known as an anaphylactic reaction. Some signs of an allergic reaction are as follows:
- Rash, blisters or hives (itchy red bumps)
- Difficulties in breathing
- Wheezing with breathing
- Sudden change in blood pressure that can cause dizziness or light headedness
- Swelling around the mouth, throat or eyes
- Fast pulse
- Sweating
An anaphylactic reaction may require emergency treatment. Report any unusual signs or symptoms you notice to the Unit medical staff straight away.
If there are any changes to the potential risks associated with the study drug during the study, you will be informed by the study doctor.
There is a theoretical risk that antibody infusion may make the disease worse via antibody-dependent enhancement (ADE). ADE occurs if specific antibodies against a virus cause the virus to replicate faster, rather that slow or stop it. ADE has been observed most clearly in the context of Dengue fever; but it is unclear if this reaction occurs and/or is clinically significant in COVID-19. The study team will monitor you closely for any signs of side effects from the study drug.
Intravenous cannulation may cause pain where the needle is inserted, phlebitis (inflammation of the vein) and bruising around the injection site. The study drug may leak under the skin. Less frequent but significant complications include bloodstream and local infections. The team will use a sterile technique to minimise the risk of infection at the site of blood draw or at cannulation.
The volume of fluid infused may make pre-existing congestive heart failure worse. There is slight increase in risk of thrombosis (formation of a blood clot in a blood vessel) with standard antibody therapy and, in some cases, COVID-19 is associated with thrombotic complications.
You may also experience other unwanted effects or discomforts with the study procedures such as:
- Blood Sample: Collecting blood may cause bruising at the place where the needle or an intravenous (IV) cannula is inserted. Fainting, and in rare cases infection, may occur. In hospital a cannula is often routinely inserted and may stay in place for a few days or a longer period. Using a cannula helps in two ways, first it prevents scars or blemishes at the sites of repeat blood samples; and helps in proper administration of medications, fluids, nutrition given via saline, and for collecting a blood sample. If a needle is used, a new needle will be used for each blood sample.
- Nose and Throat Swabs: During collection of swabs, you may experience sneezing, retching and watering of the eyes. There is also the potential for those people that are susceptible to nose bleeds to experience one.
- Blood Pressure: The blood pressure cuff used to take your blood pressure may cause discomfort or bruising to your upper arm.
- Electrocardiogram (ECG): The ECG procedure may cause discomfort and/or bruising during the attachment and removal of the leads (sticky pads) to and from the skin as well as irritation at the site of the lead application. Skin irritation is rare but could occur during an ECG from the electrodes or gel that is used. The sticky pads may be cold upon contact to the skin. In some cases, we may have to shave the area of the body where the sticky pads are attached to ensure that the pads stick to your body.
For women
We have not tested VIR-7832 in pregnant women. You will not be able to take part in the trial if you are pregnant or breastfeeding. We will ask you to have a pregnancy test during screening or the baseline visit to make sure you are not pregnant and also at the end of the trial.
Female patients, who have not passed the menopause or been surgically sterilised, must agree to use a highly effective form of contraception (outlined below) from the administration of trial treatment and for the next 24 weeks after receiving the trial treatment.
Highly effective methods of contraception:
- Hormonal contraception:
- Oral combined or progesterone pill
- Injection
- Implant
- Intrauterine device (Mirena coil)
- Intrauterine device (IUD)
- Sex with a vasectomised partner (confirmed by 2 negative semen analyses)
- Absolute and complete sexual abstinence
Only highly effective methods of contraception are acceptable.
If you become pregnant while you are taking part in the study, you should consult your doctor immediately and inform your research nurse. The doctor will advise you of the possible risks to your unborn baby and discuss the options for managing the pregnancy with you. Your research nurse will then report the pregnancy to Southampton Clinical Trials Unit (SCTU) who are running the study. Should you become pregnant during the study you will be provided with additional information and may be asked to consent to health information during the pregnancy and the birth being provided to the research team.
For men
It is not known what effect VIR-7832 will have on the testes, it is possible that the study drug will affect sperm or semen.
If there is a possibility your partner could become pregnant, you must use condoms and you or your partner must use at least one other form of highly effective contraception (outlined above) from the administration of trial treatment and for the next 24 weeks after receiving the trial treatment.
If your partner becomes pregnant while you are taking part in the study, you should consult your doctor immediately and inform your research nurse. Your research nurse will then report the pregnancy to SCTU who are running the study. The doctor will advise you of the possible risks to your unborn baby.
Your pregnant partner will be provided with additional information and may be asked to consent to health information during the pregnancy and the birth being provided to the research team.
If you agree to take part in this study you will not be able to have any COVID-19 (SARS-CoV-2) vaccine for approximately 5 and a half months after you’ve received the treatment (following Day 169).
This applies even if you choose to withdraw from the study early and did not receive placebo. If you withdraw early and received the placebo on the trial this restriction will not apply.
You also may not have any other type of vaccine (for reasons other than COVID-19) for 4 weeks after you’ve had the study drug.
If you or your doctor want to stop before the full infusion of study treatment is given, you are free to do so. If you decide that you do not wish any more information to be collected about you, you are free to say so (although de-identified information that has been collected up to that point will continue to be analysed by the research team).
Sometimes during the course of a clinical trial, new information becomes available about the drugs that are being studied. If this happens, your doctor will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw, your doctor will make arrangements for your care to continue. If you decide to continue you will be asked to sign an updated consent form.
Also, on receiving new information your doctor might consider it to be in your best interests to withdraw you from the study. He/she will explain the reasons and arrange for your care to continue.
If you have a concern about any aspect of this study, you should ask to speak with the research doctor/nurse who will do their best to answer your questions.
Please be aware that in the unlikely event that you are harmed as a result of taking part in the AGILE trial, there are no special compensation arrangements. The University of Liverpool provides clinical trials indemnity insurance for negligence in its management or design of the trial and the NHS provides professional indemnity for any clinical negligence. If you are harmed because of someone’s negligence, you may be able to take legal action but you may have to pay your own legal costs.
Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanism will be available to you:
https://www.nhs.uk/using-the-nhs/about-the-nhs/how-to-complain-to-the-nhs/
If you have private medical insurance, you may wish to check with your company before agreeing to take part in the study to ensure that participation in the study will not affect your insurance cover.
If you would like independent advice, further information or want to make a complaint you may find it useful to contact The Patient Advice and Liaison Service (PALS), which offers confidential advice, support and information on health-related matters. They provide a point of contact for patients, their families and their carers. Their contact details can be found in section 23 of this information sheet or you can find officers from PALS in your local hospital or you can find your nearest PALS office on the NHS website.
The following samples will be collected regardless of which treatment group you are randomised to.
Swabs: During the study swabs will be taken from the nose and throat.
- The swabs will be taken at Screening visit to confirm coronavrus diagnosis and on days 1, 3, 5, 8, 11, 15, 22 and 29 to measure the amount of virus in your system
- Two additional nose a throat swabs will be taken on days 1 and 5 for future scientific research if you have given your consent for this swab
Urine samples: to check your kidneys are working normally. Urine will be discarded directly after testing for blood, protein and other contents. This will be done on days 1, 3, 5, 11, 15, 22 and 29.
Blood and urine samples for pregnancy testing – Women of childbearing potential ONLY – You will be asked to provide a blood sample during Screening or at Baseline Day 1 (prior to the first dose) for pregnancy testing. When attending Day 169 visit you will be asked to provide a urine sample for pregnancy testing.
Blood samples: Blood will be taken to monitor your progress and to check for any side effects, and for storage for future scientific research. At clinic visits when we are taking the safety blood sample we will take additional blood samples at certain time points. These are each detailed below.
- Routine safety tests: to check your liver, kidneys and other body systems are working normally at your screening visit and on days 1, 3, 5, 11, 15, 22 and 29.
- PK (pharmacokinetics) samples: to see how the study drug moves through your body. You will be asked to give bloods samples on days 1, 3, 5, 8, 15, 29 and weeks 8, 12, 20 and 24. On day 1, PK will be collected before the infusion, directly after the infusion, then on 1, 2, 6 and 24 hours after the infusion to see how the study drug moves through your body over time. PK samples taken at each visit will be 2mL (less than a half a teaspoon).
- Immunology samples: to see how your immune system is responding to the study drug in your body. You will be asked to give bloods samples on days 1, 3, 5, 8, 15, 29 and weeks 12, 20 and 24. The samples taken at each visit will be 8.5mL (half a tablespoon) for immunology tests.
- Optional Genetic research sample – prior to infusion on day 1, if you have consented to to participate in the genetics analysis component of the study, we will collect a 2.5 mL (half a teaspoon) blood sample for DNA and RNA isolation.
All PK and immunology blood samples will be labelled using a patient identifier, and not your name. The PK samples, immunology, and the genetic research samples will be processed and stored securely and then sent to the laboratories of the study drug manufacturer (GlaxoSmithKline and Vir Biotechnology) for analyses.
You will be asked to give your consent to the storage of your blood samples (for use in future ethically approved research studies.)
Neither you nor your relatives will be contacted about them once they have been taken. Some of your samples may be sent for testing outside of the UK and the European Economic Area.
Yes. If you decide to take part in the AGILE trial, any data collected and any results produced will not identify you personally. Your medical records will only be available to the research doctors, your hospital consultant, individuals from the Study Sponsor organisation, Southampton Clinical Trials Unit (SCTU), regulatory authorities, authorised individuals from GlaxoSmithKline and Vir Biotechnology (who manufacture and supply VIR-7832) and NHS Trust.
The electronic copy of your consent form sent from your hospital to SCTU will be encrypted and password protected. Printed copies of the forms will be held in a locked filing cabinet within the SCTU. Access to the cabinet containing patient identifiable information will be restricted to the research team. Access to the SCTU is restricted to authorised personnel by authorised electronic door access. Data stored on NHS or University computers is only accessible by those who are permitted (via passwords) to review it. Access to this data will be strictly controlled by SCTU and applicable Data Protection Legislation will be abided by.
When you join the study you will be assigned a study number by SCTU, which will be used instead of your name and will be linked to all of your study data. This is called ‘pseudonymised data’ and you cannot be directly identified from this. Pseudonymised data will be held on servers located in and out of the UK (including the USA and EU), but access to this data will be strictly controlled by SCTU and all applicable current data protection regulations will be abided by. Pseudonymised data will be securely transferred to GlaxoSmithKline and Vir Biotechnology to assist with their analysis of trial samples and their safety reporting responsibilities.
University of Liverpool (UoL) is the sponsor for this study based in the United Kingdom. The Sponsor will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that UoL are responsible for looking after your information and using it properly. UoL will keep identifiable information about you for 30 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible.
You can find out more about how we use your information at
https://www.southampton.ac.uk/ctu/about/index.page
Your hospital will collect information from you and your medical records for this research study in accordance with our instructions.
Your hospital will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from UoL, SCTU and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your hospital will pass these details to SCTU along with the information collected from you and your medical records. The only people in UoL and SCTU who will have access to information that identifies you will be people who need to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
Your hospital will keep identifiable information about you from this study for 30 years after the study has finished.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations, regulatory agencies, or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government.
Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.
Where there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.
Anonymised information collected during the study may be transferred within or outside of the European Economic Area and SCTU is responsible for ensuring compliance with current Data Protection Regulations and protection of your privacy. At any time in the future, authorised people may look at the data which will be anonymised so your identity will not be known to them.
With your permission, we will tell your General Practitioner (GP) that you are taking part in the AGILE trial.
In the long term we would like to access your follow up details through information managed by NHS Digital (formerly known as the Health and Social Care Information Centre), so that we can obtain information on your clinical outcome in the event that you lose touch with your hospital trial doctor. With your consent, we will collect and share your name (and previous names), postcode, NHS number and date of birth with NHS Digital. The information we share will be used by NHS Digital and other central UK NHS bodies in order to provide us with information about your health status. We will keep it separately from the other information/data we collect as a result of this trial. SCTU complies with current Data Protection Regulations to hold such information on a confidential basis. Your data will be sent outside the UK where the data protection is different and may vary to the UK.
In addition, the information that you provide in the FLU-PRO Plus questionnaire (questions about how you are feeling) on days 1-15 will be shared anonymously with Leidos Biomedical Research who are the owners of FLU-PRO Plus.
You will be paid up to £1,125 for your participation in the trial. This payment is related to the expected degree of inconvenience and discomfort incurred.
When the study ends, the results will be analysed and presented at national/international meetings before being published in a medical journal. The confidentiality of all patients will be maintained. You will not be personally identified in any reports or publications resulting from the study. If you would like to obtain a copy of the published results, please ask your doctor.
This study is being coordinated by the Southampton Clinical Trials Unit (SCTU) which is an academic National Institute for Health Research (NIHR) clinical trials unit based at the University of Southampton and is UK Clinical Research Collaboration (UKCRC) registered.
The University of Liverpool is the Sponsor for the research. This means that they have overall responsibility for making sure the research is conducted in accordance with the relevant regulations.
The study is funded by the Department of Health and Social Care through NIHR Clinical Trials Unit (CTU) Support Funding, GlaxoSmithKline and Vir Biotechnology (the companies who manufactured and supply VIR-7831 and VIR-7832).
None of the doctors or other staff conducting the research are being paid directly for recruiting patients into the study.
This study has been reviewed by number of medical specialists during its development and approved by the Research and Development Department and the West Midlands – Edgbaston Research Ethics Committee to confirm that this study considered the patients’ rights and protection of patients’ health.
If you have further questions about your illness or clinical studies, please discuss them with your doctor.
If during the course of the study, you have any questions regarding your participation or would like further study specific information before making your decision please contact:
If you find the wording difficult to understand or would like us to explain things to you once more, please feel free to ask your doctor or nurse.
Thank you for taking the time to read this information sheet. If you wish to take part you will be given a copy of this information sheet and a signed consent form to keep.