Coronavirus (COVID-19) SPIKE-1 trial – CRUK’s Centre for Drug Development

A Phase 2 trial looking at the use of camostat to reduce the progression of symptoms of coronavirus (COVID-19)

This trial is for people who are over 18 and who have tested positive for coronavirus COVID-19 but are well enough to stay at home. If you have tested positive for COVID-19 at hospital, you may also be able to take part and any assessments may take place in your hospital setting, if permitted.

If you live in the Lothian, Cardiff, Rhyl, Oxfordshire, Preston, Southsea/Portsmouth or Alton Hampshire regions and think you might be eligible for this trial, please contact the team in your area:

The Edinburgh trial team: community.covid@ed.ac.uk   07341 030159

The Cardiff trial team: Charlotte.young2@wales.nhs.uk  02920 615888 extensions 4484/ 4445/ 4461/ 4448

The Oxfordshire trial team: Emma Ladds e.ladds@nhs.net  01865 881206

The Preston trial team: research@lscft.nhs.uk  01772 773498

The Southsea/Portsmouth trial team: Anna Clifford mail.j82028@nhs.net  02392 821371

The Alton, Hampshire trial team: chawton.research@nhs.net  01420 542542 

Rhyl Denbighshire: Clarence Medical Centre Rhyl practice patients only

Coronavirus COVID-19 is delaying cancer research and treatment - helping to fight the pandemic is one of the best things we can do right now to support people affected by cancer. That’s why some of our scientists and research community have joined the national and global effort to combat COVID-19. 

This trial is entirely funded by LifeArc [link is external], a charity which helps fund and develop academic research, but the trial is being run by Cancer Research UK in collaboration with Latus Therapeutics. This research is only related to COVID-19 and it is not a cancer trial.  

The trial is supported by Cancer Research UK’s Centre for Drug Development (CDD). CDD is experienced at running clinical trials and our expertise is being used in the global effort to help with the coronavirus COVID-19 pandemic whilst maintaining our ongoing clinical trials in cancer

Recruitment start: August 2020            Expected recruitment end: Dec 2021

More about this trial

This trial is looking at a drug called camostat as a possible treatment to help relieve symptoms of coronavirus COVID-19. Camostat is an oral tablet which has been used to treat pancreatitis (inflammation of the pancreas) in Japan since 1986.

  • We are inviting people aged 18 or above, to take part in this research study, also known as a clinical trial, because they have been identified as having COVID-19.
  • If you think you have COVID-19 and want to take part in this trial, you will need to have a test to confirm you have the virus. Discover how to get tested for COVID-19 (link is external)
  • You are free to decide whether or not to take part in this clinical trial.
  • You can stop taking part in the trial at any time, without giving a reason, although the information we have already collected will be kept and used as part of this research and other research into COVID-19.

Please feel free to ask us if there is anything that is not clear or if you would like more information. Contact details can be found in 'How can I join the coronavirus clinical trial?'.

Important things for you to know before reading further

This clinical trial is randomised. This means that some of the people who take part will receive camostat, and some will not. Neither you nor your doctor will be able to choose whether you receive camostat or not.

We cannot be sure if camostat will work in people with COVID-19 at this stage.

  • Camostat is known to suppress a protein (part of the building blocks of every cell in your body) called serine protease that is required for the COVID-19 virus to infect human cells.  We want to find out if camostat will block the entry of the COVID-19 virus into human cells and stop progression of the disease. This mechanism has been shown to be effective in COVID-19 in a small human trial in Japan and in animal studies for a similar type of virus.
  • Camostat could have unwanted side effects. Side effects reported since the 1980’s are rare and for everyone who takes it, less than 1% (1 in 100) of patients will experience side-effects. These are typically mild such as: rash, itching (pruritus), nausea, and abdominal discomfort, abnormalities in blood tests, e.g. low number of blood cells called platelets (thrombocytopenia) or raised potassium in the blood (hyperkalaemia) and liver disorders (usually shows in blood tests).
  • If you have tested positive for COVID-19 and are self-isolating at home we will arrange for a member of the local research team to visit you at home. This is to take some blood to make sure you can take part. We will also visit you on Day 7 and Day 14 more details about this are below.
  • If you have tested positive for COVID-19 at hospital, you may also be able to take part and any assessments may take place in your hospital setting, if permitted.
  • If you agree to take part in this clinical trial we will be relying on you to provide us with information about your symptoms. As part of this clinical trial you will monitor and document your symptoms at home, take your temperature and monitor your pulse rate and blood oxygen levels. Someone from the research team will call you every day for 14 days, to check on your wellbeing. Please note, the research team do not provide or replace usual clinical care.
  • Not everyone who comes forward for this trial will be able to take part. The person you speak to will ask you some questions to make sure it would be safe (based on our knowledge of camostat) for you to take part.
  • If you are randomised to not receive camostat then we will still contact you as mentioned above to check on your wellbeing and collect information about your symptoms.
  • If you are randomised to receive camostat, then you must not share this drug with anyone else, it must only be taken by you.

Who can join this trial?

Below are the entry conditions for this trial. Talk to the trial team via the contact details provided in 'How can I join the coronavirus clinical trial?' if you are unsure about any of these. They will be able to advise you. 

Who can take part?

You may be able to join this trial if the following apply to you.

  • You have symptoms of coronavirus COVID-19 infection, for example:
    • high temperature (greater than 37.8°C)
    • persistent dry cough
    • shortness of breath
    • a loss or change to your sense of smell or taste
  • You are aged 18 years or over
  • You have had a positive COVID-19 test and are well enough to stay at home
  • You are willing to use reliable contraception during treatment and for 28 days after your last dose of camostat if you or your partner could become pregnant.
  • You agree to share your contact details with the team running the trial
  • You agree to a small number of home visits and daily telephone or video calls

 

Who cannot take part?

You cannot join this trial if any of these apply to you.

  • You are taking part in another clinical trial using an experimental drug  
  • You are pregnant or breastfeeding or you or your partner intend to become pregnant during the trial or for 28 days afterwards

 

Medical conditions

You cannot join this trial if any of these apply to you.

  • You are allergic to camostat or similar drugs (the research team will discuss this with you)
  • You are lactose intolerant 
  • You are on long term supplementary oxygen
  • You have had a heart attack or unstable angina in the past 6 months
  • You have another serious heart condition such as congestive heart failure
  • You have had a heart arrythmia needing treatment
  • You have abnormalities shown in blood tests, e.g. low number of blood cells called platelets (thrombocytopenia) or raised potassium in the blood (hyperkalaemia), liver disorders shown in liver function tests (these will all be determined from your blood test during screening)
  • You have any other medical or mental health condition that the trial team think could affect you taking part

The trial design

This clinical trial is looking for up to 100 people to take part.

It is a randomised trial. Everyone taking part is put into 1 of 2 arms. If enrolled you will either:

  • take 200mg camostat, (2 tablets) four times a day, which is a total daily dose of 800mg, for 14 days or
  • continue with no camostat and best supportive care at home

You cannot choose which group you are in. 

You will need to monitor and document your COVID-19 symptoms at home, take your temperature and monitor your pulse rate and blood oxygen level. So everyone on the trial will be sent a trial pack to use at home.

If you are in the camostat arm, the pack will also contain a supply of camostat tablets. You will need to take 2 camostat tablets four times a day for 14 days.

For everyone on the trial, you will need to

  • check your temperature and the amount of oxygen in your blood twice a day and then once a week for another 2 weeks using the thermometer and the pulse oximeter in the pack
  • use the questionnaire to think about your coronavirus COVID-19 symptoms
  • use the diary card to record your readings and symptoms and, if you are taking camostat, the times you take your tablets

You may be asked to take small saliva (spit) samples during the first 14 days. Not everyone will be asked to do this. Your research team will discuss this with you when you are randomised. If you are to give saliva samples, we will provide the tubes in your trial pack and you will be asked to keep these at home until they are collected by a member of the research team.

Home visits

Before you can join this trial, you will already have had a coronavirus COVID-19 test done and your result confirmed that you have a positive COVID-19 infection. You will then need to go through our trial screening process to make sure it would be safe (based on our knowledge of camostat) for you to take part. Screening will include:

  1. An initial discussion (e.g. by video or phone call) with a member of the research team so they can ask you a few questions about your symptoms and medical history.
  2. A home visit by a member of the research team to perform the following tests which should take less than an hour:
    • A saliva sample: We will ask you to give a saliva sample (spit) into a tube. You will also need to give a sample for each of the 14 days you take camostat. These samples will be collected and stored for future research analysis. 
    • Two small blood samples: (less than 2 tablespoons) will be taken from a vein in your arm, one for routine analysis and the other will be stored for future research analysis

When we have reviewed your screening results, we will let you know if you can take part in the trial. If you are eligible to take part, you will be randomised and your trial pack will be delivered to you.

After 7 days on the trial, and then again at 14 days, someone will visit your home to repeat the following tests:

  • A nose and throat swab to check whether you still have a positive COVID-19 infection.
  • Two small blood samples will be taken, one for routine analysis and the other will be stored for future research analysis.

When you are seen on Day 7 by a member of the clinical team and if, following discussion with your trial doctor, your doctor feels you have recovered from COVID-19 then you may be able to stop taking the camostat tablets. Your doctor will discuss this with you at the time.

Telephone or video calls

During the trial someone from the trial team will call you once a day for 14 days to discuss your symptoms, ask for your readings and check on your wellbeing. They will also:

  • ask for your temperature and blood oxygen readings
  • review your questionnaire and discuss your COVID-19 symptoms and any new symptoms you develop

For this reason, your contact details are important. We will need to give them to the people who make the calls (it may not be the same person every day).

You may be asked to nominate a 'Trial Partner' that the research team can contact if you are not feeling well and cannot come to the phone. This can be someone else in your household or one of your next of kin.

The information we collect about you and what happens to you while you are on the trial will be kept in your diary card and put on our secure clinical trial database.

After you have finished 14 days on the trial, we will call you again two times after 21 days and 28 days:

  • to ask for your temperature and blood oxygen readings
  • to review your questionnaire and discuss your COVID-19 symptoms

What are the possible side effects?

The person on your daily call will monitor you closely for any side effects. You must report if you feel unwell or in any way different from usual while taking camostat to them. You will also have emergency contact details for your research team if you become worried at any time.

Camostat has been used for over 30 years in Japan and side effects are rare (less than 1% of patients) and are mainly mild:

  • rash
  • itching (pruritus)
  • nausea
  • abdominal discomfort
  • abnormalities in blood tests e.g. low number of blood cells called platelets (thrombocytopenia) or raised potassium in the blood (hyperkalaemia) and liver disorders (usually shows in blood tests)

A small number of patients in Japan reported allergic type reactions such as:

  • tightness in the throat
  • swelling or tingling in the lips
  • difficulty in breathing or noisy breathing

If you experience allergic reactions you must stop taking camostat and call 999 immediately if the allergic reaction is severe.

If, for any of your oxygen saturation readings, the result is 94% or lower or if your pulse rate rises above 100 beats per minute (after sitting for 10 mins at rest), please repeat the readings. If either of the readings remains below 94% for your oxygen saturation levels or above 100 beats per minute, please directly contact your GP or call NHS 111 for advice. Please also contact your research team contact to let them know but your priority should be to contact your GP or NHS 111 first.

If you feel your symptoms are getting worse and you cannot breathe very easily you must call your GP, or NHS 111 (link is external) or if the symptoms are really bad dial 999 immediately. Tell whoever you speak to you are taking part in this clinical trial.

If you are admitted to hospital or experience any side effects from camostat we will need to follow-up with you or through your doctors for a little longer. When these have settled you will no longer be on the trial.

How can I join the coronavirus clinical trial?

Interested in taking part?

People can only take part in this trial if they are over 18 and have coronavirus COVID-19

If you think you have COVID-19 and want to take part you will need to have a test to confirm you have the virus  Discover how to get tested for COVID-19 (link is external)

If you have had a positive result from your COVID-19 test and you are interested in taking part in this trial you will need to:

  1. Email or phone the clinical trial team to register your interest in participating

 

The following clinical research centres in the UK are currently participating in this trial:

 Clinical Research Centre   Catchment area for participation    Email address          Telephone no.   
 Edinburgh University City of Edinburgh, East Lothian, Midlothian, West Lothian  community.covid@ed.ac.uk       07341 030159
 Velindre Cardiff  Cardiff

charlotte.young2@wales.nhs.uk 

amanda.jackson2@wales.nhs.uk 

debbie.o'connor@wales.nhs.uk

     02920 615888  extensions 4484/ 4445/ 4461/ 4448

 Eynsham Medical Group, Oxfordshire  Oxfordshire Emma Ladds  e.ladds@nhs.net      01865 881206
 Preston Lantern Centre  Preston & surrounding area  research@lscft.nhs.uk      01772 773498
 Trafalgar Medical Practice, Southsea  Southsea & Portsmouth areas  Dr Singh, Nurse Allison or Anna Clifford  mail.j82028@nhs.net      02392 821371
Chawton Park Surgery Alton, Hampshire Chawton Park Surgery, Boundaries Surgery, Bentley Village surgery & the Wilson practice, Alton Hampshire  chawton.research@nhs.net     01420 542542
Clarence Medical Centre Rhyl, Denbighshire  Rhyl practice patients only Practice patients only Practice patients only
       

 

More clinical research centres are planned to open in other parts of the UK and details will be added when available

If you do not live in the areas noted above, or if you do not meet the trial criteria, you may be eligible for another community based COVID trial, which is being run by University of Oxford. Please see details here: principletrial.org (link is external)

Q. I am based in a different part of the country to the listed clinical centres, can I still take part?

Unfortunately at the moment you can only take part if you live within the regions listed in 'How can I join the coronavirus clinical trial?'. More clinical centres are planned to open in other parts of the UK and details will be added when available. If you are unsure, then please contact the research team in the region closest to you, they will be able to advise whether you can take part based on your home address.

 

Q. I think I have coronavirus COVID-19 but I have not had a test. Can I still join the trial?

You will need to take a COVID-19 test before you can join the trial. Discover how to get tested for coronavirus COVID-19

 

Q. How long will the trial last?

The trial is expected to last 12 to 18 months. People are expected to be on the trial for 28 days. If you are admitted to hospital we may need to follow-up with you or through your doctors for a little longer. 

 

Q. How long will you keep in touch with me?

We will keep in touch with you during your time on the trial every day for 14 days and then once a week for the next 14 days.

 

Q. What happens if my symptoms get worse and I have to go to hospital?

If you feel your symptoms are getting worse and you cannot breathe very easily you must call your GP, or NHS 111 or if the symptoms are really bad dial 999 immediately. Tell whoever you speak to you are taking part in this clinical trial.

 

Q. Will I get paid for joining this trial?

You will not be paid for taking part in this clinical trial. However, if you need to travel to see a doctor or nurse, we will pay reasonable travel expenses for you and a trial partner.

 

Q. Why is Cancer Research UK recruiting for this trial as a cancer charity?

Coronavirus COVID-19 is delaying cancer research and treatment. Helping to fight the pandemic is one of the best things we can do right now to support people affected by cancer. That’s why some of our scientists and research community have joined the national and global effort to combat coronavirus COVID-19. 

 

Q. Will there be any financial impact for CRUK recruiting for this trial?

No, there will be no financial impact for CRUK. The study is completely funded by LifeArca charity which helps fund and develop academic research.

Questions about the trial?

 For COVID-19 patients

For Clinical Centre Staff

  • Please email us here.  Please note for COVID-19 patients – your queries will not be addressed via this channel.

 

Chief Investigator Professor Kev Dhaliwal, University of Edinburgh

Funded by LifeArc (link is external)

Supported by Cancer Research UK Centre for Drug Development and Latus Therapeutics