Issue 1 • 2022
© 2022 The Royal Australasian College of Physicians
Nasal spray to combat COVID-19 heads to clinical trial
A ‘wild idea’ has resulted in Professor Don Campbell being awarded $4.2 million by the Victorian government to develop a novel COVID-19 prevention tool.
All eyes are on Professor Don Campbell, Medical Division Director of Hospital Without Walls, Northern Health, and President of RACP’s Adult Medicine Division, and his team, as they undertake a clinical trial that could change the COVID-19 landscape as we know it.
Professor Campbell has proposed a solution which has come from an unexpected direction. At present, it shows promising signs of preventing the infection and transmission of COVID-19. To aid further research, Professor Campbell and his team have received a significant fund of $4.2 million from the Victorian Government to run the clinical trial, recruit staff, and put together a steering group.
This novel and innovative idea came from a past and underexplored curiosity. During his doctoral research studies on the immunology of interstitial lung disease, Professor Campbell took a strong interest in heparin; a common blood-thinning drug because of its widespread distribution and the fact that it is phylogenetically preserved from macro algae through to humans. He was sure that it could do more than its intended purpose, but he pushed the idea to the back of his mind.
A couple of decades later when the COVID-19 virus began to spread, Professor Campbell said he was struck by ‘a crazy idea’ from his research that heparin could potentially stop the virus growing in cells. With prompts from his wife, he immediately began researching his idea and connecting with his network.
Two years on, Professor Campbell has pulled together a team of professional colleagues from across Australia and beyond, describing the set-up as an ‘incredible collaboration between basic researchers, clinical researchers and clinicians’. He highlighted the importance of building strong connections with colleagues throughout his 35-year career, as doing so has helped garner widespread support for this project.
As such, while the clinical trials will be run out of Northern Health in Victoria, where Professor Campbell is based, there are numerous research and clinical partners who are also involved.
These include Murdoch Children’s Research Institute, the Doherty Research Institute, St Vincent’s Hospital, Western Health and the Royal Melbourne Hospital, pharmacologists from the University of Melbourne and pharmacists from the Monash Institute of Pharmaceutical Sciences.
The collaborative team has successfully replicated international findings which show that heparin can indeed block the infection of nasal epithelial cells in culture by COVID-19, and therefore potentially prevent infection. Furthermore, it could also provide the same function in preventing infection and therefore transmission of influenza, the common cold, RSV, and other upper respiratory viral infections.
‘When [COVID] first gets into the nose it binds to a naturally occurring molecule on the nasal epithelial cell surface called heparan sulfate,’ he said. ‘Heparin is so close in structure to heparan sulfate that it binds the virus Protein S spike very tightly, so it prevents cell infection and also stops the virus from spreading to others.’
‘It won’t matter if a new variant comes along, this drug will block that protein S spike from attaching to and infecting the cells,’ Professor Campbell said. ‘I’m very confident that we can demonstrate that it will work. People will be using this before they go to the shops and before they go to school.’
Professor Campbell further commented, ‘We anticipate that administering heparin will be useful in high-risk settings, such as healthcare, travel, and mass exposure events. If we can demonstrate that heparin is effective when used as early treatment and post exposure prophylaxis against COVID-19, it will have particular usefulness as early treatment to reduce symptom duration and severity, reduce viral load, and as pre- and post-exposure prophylaxis to reduce transmission.’
Professor Michelle McIntosh, Director of the Medicines Manufacturing Innovation Centre at Monash University, explains: ‘One of the wonderful things about heparin is it is already available on the market as an approved product for another purpose, it doesn’t require refrigeration and can be stored in plastic vials so it can be distributed very widely and effectively.’
In terms of the drug preparation, Professor Campbell believes that the next phase in dealing with the pandemic is to develop drug therapy as an adjunct to vaccination to prevent the spread of COVID-19, particularly focusing on the nose.
With that in mind, the team has focused on developing a nasal spray as it can be easily distributed, while also being familiar and comfortable for people to use.
‘Everyone knows about the concept of a nasal spray, so we can make this widely available through established networks,’ Professor Campbell said.
The team is intent on producing a convenient treatment that simply requires spraying heparin in each nostril, which will hopefully coat the mucosal lining of the nose and kill the virus on contact.
Professor Campbell said that intranasal heparin is safe and odourless. It does not go down into the lungs, nor will it enter the blood stream. It is therefore likely to be safe to use even for people who already use heparin for blood thinning purposes. Furthermore, it is cheap, stable at room temperature for many months, and can be easily transported.
While heparin is already widely available, looking at the long-term, there’s great potential for investment in this treatment.
‘Heparin is the second most commonly used drug in the world, so there’s a critical dependency there. If we show that intranasal heparin works, we expect there to be a considerable draw on the existing worldwide supply chain for heparin, and this creates the opportunity for us to address the question of sovereign capability by establishing a heparin manufacturing industry here in Australia.’
In January 2022, the team submitted a proposal to the Human Research Ethics Committee but changing isolation requirements have meant some last-minute changes to clinical trial strategies.
Over the next six months, the team plans to reach households in the northern suburbs of Melbourne within 24 hours of being diagnosed with COVID-19 and invite them to enter the trial. They will be given either the heparin nasal spray or a placebo nasal spray.
The team does not see the nasal spray as an alternative to vaccination; rather, that it will be used widely as an additional preventative measure against COVID-19.
If the clinical trials confirm the results displayed in the in vitro research phase, it is hoped that the heparin nasal spray will be made available by the end of 2022.
Professor Campbell thanks the Victorian Government and the College for assisting with this work, praising the fertile environment created by networking and working together, which has been hugely impactful on the success of this project to date.
To get this project off the ground, Professor Campbell harnessed relationships he has built with a range of medical and scientific professionals throughout his training and career. He stresses the importance of research training for clinicians and that, without this training experience, a world-changing project such as this would not be possible.
Professor Don Campbell concludes, ‘The one point to emphasise: this is a collaboration between basic scientists, clinical scientists, and clinicians, and the fact that we can run this in Australia is frankly a testament to our medical science research capabilities, and the strength of our clinician investigators. And the RACP is front and centre of that clinical investigative space.’