Coronavirus (COVID-19) SPIKE-1 trial – CRUK’s Centre for Drug Development
A Phase 2 trial looking at the use of camostat to help relieve symptoms of COVID-19
The COVID-19 pandemic was delaying cancer research and treatment - helping to fight the pandemic was one of the best things we could do to support people affected by cancer. That’s why some of our scientists and research community joined the national and global effort to combat COVID-19.
This trial was entirely funded by LifeArc, a charity which helps fund and develop academic research, but the trial was run by Cancer Research UK. This research was only related to COVID-19 and it was not a cancer trial.
The trial was supported by Cancer Research UK’s Centre for Drug Development (CDD). CDD is experienced at running clinical trials and our expertise was used in the global effort to help with the COVID-19 pandemic whilst maintaining our ongoing clinical trials in cancer.
Recruitment started: August 2020. THE TRIAL CLOSED TO RECRUITMENT IN MARCH 2022.
THE RESEARCH TEAM WOULD LIKE TO THANK ALL THE PEOPLE WHO TOOK PART IN THIS TRIAL. BY DOING THIS, YOU HAVE HELPED THE RESEARCH TEAM LEARN MORE ABOUT COVID-19 AND HOW TO TREAT IT.
More about this trial
Trial Title: SPIKE-1 A randomised Phase II trial in early COVID-19, assessing the use of camostat by blocking SARS-CoV-2 Spike protein-initiated membrane fusion
This trial looked at a drug called camostat as a possible treatment to help relieve symptoms of COVID-19. Camostat is an oral tablet which has been used to treat pancreatitis (inflammation of the pancreas) in Japan since 1986.
- People aged 18 or above who had tested positive for COVID-19 were invited to take part in this clinical trial
Summary of Results
The trial team found that the side effects caused by camostat were manageable. They could not confirm how well camostat worked against COVID-19 in preventing hospitalisation and additional oxygen requirements.
The Trial Design
There were changes made to the aims of the trial during its course. This was because the way COVID-19 was treated changed and other COVID-19 treatment trials changed.
The main aim was to find out more about the side effects relating to camostat. The trial also looked to see if treatment with camostat meant fewer people with COVID-19 needed hospital stays or additional oxygen.
- 34 people agreed to take part in the trial and met all the trial requirements.
- 16 people were chosen at random to receive camostat. 18 other people were chosen at random to not receive camostat.
The main requirements to take part in the trial were that people:
- were willing and able to agree to take part
- were adults (aged 18 or over)
- had symptoms of COVID-19
- tested positive for COVID-19
People could not take part in the trial if:
- the results of their electrolyte or enzyme tests were out of the normal range
- they needed long term additional oxygen
EFFECT ON COVID-19 SYMPTOMS AND HOSPITALISATION
- 2 of 14 people (14%) who had camostat and 3 of 18 people (17%) who did not have camostat were hospitalised. They were all admitted for treatment of COVID-19 related symptoms.
- 12 of 14 people (86%) who had camostat and 17 of 18 people (94%) who did not have camostat completed the trial without needing additional oxygen.
- 3 of 32 people (9%) had additional oxygen.
- No people on this trial needed a ventilator.
- There was no difference in the duration or severity of COVID-19 between the people who had camostat and those that did not.
- Blood samples were collected from some people. These will be used where possible to learn more about camostat and COVID-19 outside of the trial.
- The researchers had also planned to look at camostat levels in blood samples. No blood samples were collected for this so there are no results.
In total, 6 people experienced at least one side effect related to camostat.
The most common side effects caused by camostat were:
- 3 people (20%) had diarrhoea
- One person (7%) had indigestion (dyspepsia)
- One person (7%) had vomiting
- One person (7%) felt sick (nausea)
- One person (7%) had low levels of potassium in the blood (hypokalaemia)
- This study found that the side effects caused by camostat were manageable.
- A difference between the number of people with COVID-19 that were admitted to hospital, who had or had not taken camostat, was not found.
- As the trial closed before enough people were recruited, the researchers were not able to confirm how well camostat worked against COVID-19.
- This summary only shows the results from this one trial. Other trials using camostat in the future may show different results.
- Results from this trial are being looked at by a group of scientists from around the world who have been doing research on camostat in COVID-19.
- At the moment, there are no more trials planned for camostat.
- The CRUK trial number is CRUKD/20/002.
- There is more information about this trial on the ClinicalTrials.gov website (ClinicalTrials.gov Identifier: NCT04455815)
- Associated publication: Halford S, Wan S, Dragoni I, et al. SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion. Trials. 2021;22(1):550.
This trial was funded by LifeArc, a charity that helps fund and develop academic research.
The trial sponsor, who runs the trial and manages the results, was
Cancer Research UK Centre for Drug Development.
Address: 2 Redman Place, London E20 1JQ
Phone: +44 (0)20 7242 0200
Cancer Research UK Information Nurses Helpline: Freephone 0808 800 4040