SPIKE-1 [COVID-19]
Research type
Research Study
Full title
A Randomised Phase II trial in early COVID-19, assessing use of camostat by blocking SARS-CoV-2 Spike protein-initiated membrane fusion
IRAS ID
282538
Contact name
Kevin Dhaliwal
Contact email
Sponsor organisation
Cancer Research UK, Centre for Drug Development
Eudract number
2020-002110-41
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
This is a phase II/III randomised , multi-centre, prospective, open label, community-based clinical trial. The trial aims to recruit patients who test positive for COVID-19 but who have mild disease and therefore can treat their symptoms in the community. Patients (50 years or older) who seek testing and have a confirmed positive test result will be invited to enrol in the trial. The trial has a pilot phase and then a continuation phase. Patients will be randomised into a treatment arm (camostat tablets) or control arm (best supportive care). Patients will be called daily at home for 14 days by the clinical trial team to collect symptoms and record the general well-being of the patient. The primary aim of this trial is to determine if camostat can reduce the clinical progression of COVID-19 and therefore the need for hospital admimission and supplemental oxygen. Secondary aims include collection of patient reported health status, severity of symptoms and biological markers of the virus. As the understanding of COVID-19 develops and improves, the inclusion criteria may be adapted to support the trial outcomes. Patients will be recruited through various settings which may include primary care ‘COVID-19 hub’ clinics, COVID-19 community-based testing centres or other clinical environments.
Summary of Results
SUMMARY OF RESULTS• THE RESEARCH TEAM WOULD LIKE TO THANK ALL THE PEOPLE WHO TOOK PART IN THIS TRIAL. BY DOING THIS, YOU’VE HELPED THE RESEARCH TEAM LEARN MORE ABOUT COVID-19 AND HOW TO TREAT IT.
• 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.
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 related to camostat. The trial also looked to see if treatment with camostat meant fewer people with COVID-19 needed hospital stays or additional oxygen.
RESULTS
• 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:
o were willing and able to agree to take part;
o were adults (aged 18 or over);
o had symptoms of COVID-19;
o tested positive for COVID-19.
• People could not take part in the trial if:
o the results of their electrolyte or enzyme tests were out of the normal range;
o 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.
SAMPLES
• 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.SIDE EFFECTS
• In total, 6 people experienced at least one side effect related to camostat.
• The most common side effects caused by camostat were:
o 3 people (20%) had diarrhoea.
o One person (7%) had indigestion (dyspepsia).
o One person (7%) had vomiting.
o One person (7%) felt sick (nausea).
o One person (7%) had low levels of potassium in the blood (hypokalaemia).
CONCLUSION
• 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.
FUTURE PLANS
• 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.
SUPPORTED BY
• 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).
o Address: 2 Redman Place, London E20 1JQ
o Phone: 020 7242 0200
o Email: regulatory@cancer.org.uk
o Cancer Research UK Information Nurses: Freephone 0808 800 4040Other information
• The CRUK trial number is CRUKD/20/002.
• There is more information about this trial on the clinicaltrials.gov website [https://clinicaltrials.gov/ct2/show/NCT04455815] (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.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0278
Date of REC Opinion
18 Jun 2020
REC opinion
Further Information Favourable Opinion