About the trial
The Arcadia Clinical Trial is investigating a potential new therapy for people who have type I or type II diabetes and COVID-19.
The investigational drug we are trialling is called AZD1656. Approximately 960 patients have taken this drug across 25 clinical trials to date.
These trials show that AZD1656 can help to control blood sugar levels in patients for up to 4 months.
Based on what we know, AZD1656 may effect people with diabetes and COVID-19 in two ways:
- It may help to control your blood sugar levels (recent studies have shown people with diabetes and hyperglycaemia (high blood glucose levels) during COVID-19 infection may have worse outcomes than those who do not have hyperglycaemia)
- It may also help reduce excessive inflammation in the lungs and other organs, which is sometimes seen in patients with COVID-19. This effect has not yet been proven and will be studied during this trial.
The Arcadia Clinical Trial is being funded by the UK biomedical charity, St George Street. The trial is also being funded by the UK Government through the UK Research and Innovation (UKRI) funding agency in addition to private investors.
St George Street is also working with Queen Mary University London who have already completed a range of laboratory work on AZD1656 and its effect on the immune system.
More information about the Arcadia Trial
What are the potential effects of AZD1656?
Based upon what we know about AZD1656, we think the potential therapy may have two possible effects on people with COVID-19 and diabetes.
The first effect is helping control blood glucose levels. This has been demonstrated in previous clinical trials with diabetic patients. The reason blood glucose control may be important in COVID-19 is that some studies have shown people with diabetes and with hyperglycaemia (high blood glucose levels) during COVID-19 infection may have worse outcomes than those who do not have hyperglycaemia.
The second potential effect of AZD1656 is that it may help reduce excessive inflammation in the lungs and other organs, which is sometimes seen in patients with COVID-19. We think it does this by activating your body’s own immune system, specifically T regulatory cells, and sending them to the areas of inflammation.
T regulatory cells are one of the major ways the body can reduce inflammation and are also important in repairing the damage caused by inflammation. It is key these T regulatory cells migrate to the site of inflammation to exert all their anti-inflammatory effects. This effect has not yet been proven and will be studied during this trial.
What to expect on the Arcadia Clinical Trial?
Whether a patient agrees to participate in this study or not, they will receive the usual care provided to all diabetic patients in hospital with COVID-19.
If a patient agrees to participate and meet the entry requirements of the study, they will be assigned to one of two treatment groups. The treatment group that they will be in is selected by chance, like tossing a coin. Half of the study patients will receive AZD1656 (the active drug) and half will receive placebo (a dummy pill that looks the same as AZD1656 but does not contain the active drug). This study is what’s called “double-blinded”. This means that neither the patient nor the study doctor will know whether you are taking AZD1656 or placebo. If required for a medical need, the doctor is able to find out which treatment the patient is receiving.
Each day whilst the patient is on the study, they will take two tablets with their breakfast and two tablets with their evening meal. The tablets must be taken with food because the medicine has been shown to lower blood glucose levels. Patients must not take the tablets without food. If a patient misses a dose, take the next dose at the usual time. Patients will receive the study tablets for up to a maximum of 21 days. If their symptoms significantly improve (and the patient is to be discharged from hospital) or significantly worsen during this 21-day period, study treatment will be stopped.
The study is trying to find out how the body and the immune system responds to AZD1656 and to find out how effective it is. Therefore, once patients begin taking the study medication some blood tests and assessments will be taken at regular intervals until the day that they stop taking the medication. These are the following:
- Blood pressure, pulse, temperature and oxygen levels (measured using a finger probe)
- What type of breathing support is required, if any (e.g. Oxygen)
- Safety blood tests – a maximum of 40 mL (8 teaspoons) taken over 4 timepoints during the study
Bloods tests to look at the following items:
- Vitamin D levels – 5 mL (one teaspoon)
- An assessment of current glucose control – 5 mL (one teaspoon)
- How the immune system is responding to the treatment – a maximum of 100 mL (20 teaspoons) taken over 4 timepoints during the study
- The concentration of the study drug in the blood – a maximum of 3 mL (less than 1 teaspoon) taken over 3 timepoints during the study
- The clotting of their blood (only if your study site has the facilities to store the samples for this test and if patients agree to this test) – a maximum of 9 mL or (2 teaspoons) taken over 2 timepoints during the study.
Who is eligible to take part in this study?
Any patient with either Type I or Type II diabetes that has been admitted to hospital with suspected or confirmed COVID-19 may be eligible to take part in this study. The patient will have to undergo some procedures and answer some questions before the study doctor will confirm if you can take part.
Is it compulsory to take part?
No. The patient can decide not to take part. Even if they do take part, they can change their mind at any time and withdraw from the study. They don’t have to give a reason for this. They will still receive the usual hospital treatments and care no matter what they decide to do.
What will the patient have to do to take part?
The patient will have to take the study medication during their hospital stay only. If the patient gets better and are discharged from hospital, they will stop the study medication as they will no longer need it. If their symptoms worsen, then they may have to stop the medication depending on the treatments or procedures that are needed to treat them.
They will also have to agree to the study procedures. Most of these will follow the routine hospital care. However, the study does include additional blood samples to look at how the study drug is working in their body. Please refer to section 5 of the full Patient Information Sheet for information on the study procedures and additional samples. The study doctor may specifically ask that the patient agrees for two clotting factor blood samples to be taken on Day 1 (V2) and Day 8 (V9). This sample is optional. Therefore, the patient may opt out of this if they want to. The patient must confirm to the study doctor if they are happy for this sample to be collected.
How will this study affect the patient’s hospital treatment and diabetic treatments?
This study will not interfere with any of the treatments and care the patient needs while they are in hospital. The patient will also be able to take any medications they took before they came into hospital. Some of the patient’s diabetic medications may need adjusting. However, this may also be because they have COVID-19 which can affect their blood glucose. If the patient must stop any of their usual drugs, the study doctor will explain the reasons for this.
What is the study drug?
This study will trial an investigational drug called AZD1656. This investigational drug was developed as a treatment for diabetes. Approximately 960 people have taken this investigational drug in 25 previous clinical trials. In these trials AZD1656 was shown to help control blood sugar levels for up to 4 months. As the effects did not last beyond 4 months, it was not considered useful as a long-term treatment for diabetes. However, a short course of AZD1656 whilst the patient is in hospital with COVID-19 may help to better control their glucose and may have beneficial effects on their immune system.
Will every patient get the investigational drug?
If the patient agrees to participate and meet the entry requirements of the study, they will be assigned to one of two treatment groups. The treatment group that they will be in is selected at random. Half of the study patients will receive AZD1656 (the investigational drug) and half will receive placebo (a dummy pill that looks the same as AZD1656 but does not contain the active investigational drug). This study is “double-blinded”. This means that neither the patient nor their study doctor will know whether they are taking AZD1656 or placebo. If required for medical reasons, the doctor is able to find out which treatment the patient is receiving.
What will happen to the patient's data?
The patient’s data will be identified only by a unique study code, so their taking part will be confidential. Their personal information, collected during the study, will be processed to monitor their safety and the safety of others participating in the study and to ensure the study is running according to the protocol and to ethics committee and regulatory authority guidelines. For more information on how the patient’s data will be protected, please refer to section the full Patient Information Sheet. The study doctor can review this with the patient.
Will the patient be able to take other medications such as dexamethasone whilst on the Arcadia Trial?
The medical doctor will determine what medications their patient should take in hospital. This will include deciding which of their usual medications a patient can take and whether they should take other medication such as dexamethasone alongside the study drug.
Where is the Arcadia Trial being run?
The Arcadia Trial is being run at 12 hospitals currently in the UK including:
- Barnsley Hospital NHS Foundation Trust
- Barts and The London NHS Trust – The Royal London Hospital (RLH)
- Barts Health NHS Trust (Whipps Cross University Hospital NHS Trust (Wxuht)) – Whipps Cross University Hospital
- Bradford Teaching Hospitals NHS Foundation Trust
- Hull And East Yorkshire Hospitals NHS Trust – Castle Hill Hospital
- Hull And East Yorkshire Hospitals NHS Trust – Hull Royal Infirmary
- Medway NHS Foundation Trust – Medway Maritime Hospital (MMH)
- Musgrove Park Hospital
- North Bristol NHS Trust – Southmead Hospital
- Sheffield Teaching Hospitals NHS Foundation Trust – Royal Hallamshire Hospital (RHH)
- The Dudley Group Of Hospitals (DGOH) NHS Foundation Trust – Russells Hall Hospital
- The Pennine Acute Hospitals NHS Trust – North Manchester General Hospital (NMGH)
- Walsall Healthcare NHS Trust – Manor Hospital
In addition we expect to open 4 more sites in December 2020 including Bolton, Scunthorpe, Liverpool and Darlington.
When did the Arcadia Trial begin enrolling patients?
The Arcadia Clinical Trial began to recruit patients in September 2020.
For hospitals and doctors
If you are a doctor treating hospitalised COVID-19 patients in the UK and would like information on how to take part in the study please contact firstname.lastname@example.org.
About St George Street
St George Street is a biomedical research charity on a mission to fast-track clinical trials so we can get new treatments as quickly as possible to the people who need them. We apply bold new thinking to unlock the therapeutic potential of therapies and science currently sitting on the shelf in pharma. We are a new type of charity, sourcing investment to accelerate clinical trials, where new science shows great potential and where patients and clinicians are calling out for treatments. St George Street was established in 2017 and brings together a powerful mix of expertise, from clinical scientists and researchers to investors and business managers.
Visit us at www.sgscapital.org.