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

A Phase 2/3 trial looking at the use of camostat to reduce the progression of symptoms of coronavirus (COVID-19)

This trial is for people who are 50 years or older and who have tested positive for coronavirus (COVID-19) but are well enough to stay at home.

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). 

This trial is entirely funded by LifeArc, a charity which helps fund and develop academic research, but the trial is being run by Cancer Research UK. This research is only related to coronavirus (COVID-19) and it is not a cancer trial.  

The trial is supported by Cancer Research UK’s Centre for Drug Development (CDD). Our 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: July 2020            Expected recruitment end:  August 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 50 years old or above to take part in this research study, also known as a clinical trial, because they have been identified as having coronavirus (COVID-19).
  • If you think you have coronavirus (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 coronavirus COVID-19
  • 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 coronavirus 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 coronavirus (COVID-19) you will now be self-isolating. 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 and after 21 and 28 days, to check on your wellbeing, and someone will visit you at home a couple of times to take blood samples and other tests. 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.

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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 typical symptoms of coronavirus COVID-19 infection:

    • high temperature (greater than 37.8°C)
    • and/or persistent dry cough
    • and/or shortness of breath
  • You are aged 50 years or older
  • You have had a positive coronavirus 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/hospital 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

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The trial design

This clinical trial is in 2 parts:

  • An initial phase called a pilot phase of around 100 people 
  • A continuation phase of around 300 people

The trial is currently looking for people to take part in the pilot phase.

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

  • take 200mg camostat (2 tablets) four times a day (total daily dose 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 we would like saliva samples to be taken, we will provide the tubes in your trial pack and you will be asked to keep these in your freezer at home until they are collected by a member of the research team.

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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. Screening will include:

  1. An initial video or phone call with a member of the research team so they can ask you a few questions about your medical history to make sure it would be safe (based on our knowledge of camostat) for you to take part.
  2. A home visit by a member of the team to perform the following tests which should take less than an hour:
    • Your COVID-19 test result: You will already have had a test done, with your result confirming that you have a positive coronavirus COVID-19 infection. You will need to show us the positive result from your COVID-19 test.
    • 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 phone you to 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 your home.

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 coronavirus (COVID-19) then you may be able to stop taking the camostat tablets. Your doctor will discuss this with you at the time.

At the end of the trial, your clinical research team will be in touch with you to collect the thermometer and oximeters from your home. Someone from your clinical research team may visit you to collect these or we may give you pre-paid packaging to send these back to the hospital.

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Telephone or video calls

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

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

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 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 coronavirus (COVID-19) symptoms

If you agree, we may check in with you a year after you have taken part in the trial. We may contact you directly or get the information from your GP or local hospital.

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What are the possible side effects?

The person on your daily call will monitor you closely for any side effects. You must report any medical problems you have to them. You will also have an emergency contact number to phone 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 generally mild:

  • rash
  • itching
  • 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 will need to stop taking camostat immediately.

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.

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.

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How can I join the coronavirus clinical trial?

Interested in taking part?

People can only take part in this trial if they are 50 years or older and have coronavirus (COVID-19)

If you think you have coronavirus 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 coronavirus COVID-19

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

  1. Read the Informed Consent Document here 
  2. Email or phone the clinical trial team to register your interest in participating

 

A number of clinical research centres in the UK will be participating in this trial

 Edinburgh         Contact the Edinburgh team [link]            0xxxxxxxxxxxx Phone number          
     
     
     
     
     
     
     

 

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

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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, but we may follow up with some people one year later. If you are admitted to hospital we will 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. We may follow up with you one year afterwards to check in, or we may speak directly to your GP. 

 

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

  • Contact your clinical centre team, see 'How can I join the coronavirus clinical trial?
  • 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.

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

Supported by Cancer Research UK Centre for Drug Development

 

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