What is the INHERIT trial designed to show?
The INHERIT trial will determine whether heparin nose spray will prevent the spread of COVID when given to a person with COVID and their household family members.
What sort of trial is it?
The trial is a double-blind randomised placebo-controlled trial. Double- blinding means that, at the time of the trial, neither the trial participants nor the researchers conducting the study are aware which person is receiving a placebo (saline nasal spray) and which is receiving the heparin spray. All members of the same household will receive the same treatment.
How will the study be conducted?
Up to 400 families will be enrolled in the study, with up to 1100 individual trial participants overall. Trial participants will be treated with the nasal spray for ten days. They will complete a daily symptom questionnaire via an App and have repeated nasal swabs taken to look for COVID virus. The swabs will be a combination of trial staff performed swabs and easy self-administered swabs. All swabs will be collected from the participant’s home. Participants will be followed up for a period of twelve months to see if they have any evidence of post-COVID symptoms (sometimes referred to as long COVID).
How does the COVID-19 virus infect a person?
The COVID-19 virus attaches to receptors on the cell surface in the lining of the nose. The Protein S spike on the COVID-19 virus attaches to the lining of the nose by binding to a cell surface receptor which contains naturally occurring heparan sulfate. The COVID-19 virus replicates in the lining of the nose and then spreads in the atmosphere by droplet and aerosol dispersion which can infect other people. Within a person the virus spreads from the nose via the bloodstream and can infect other organs within the body.
What is heparin and why could it work against the COVID-19 virus?
Heparin is a member of a family of molecules called glycosaminoglycans that are widespread throughout nature and in humans. Heparin is used as a blood thinner when given via a vein into the bloodstream. The heparin that is used as an intravenous treatment is derived from animals and has been used worldwide for this purpose for over 80 years in humans. When administered to the nose via a spray, heparin is not absorbed into the body because the heparin molecule is too large. Heparin administered to the nose via a spray is therefore extremely safe. Heparin administered via the spray should bind the protein S spike on the COVID-19 virus if it is present within the nasal cavity. This should prevent the protein S spike on the COVID-19 virus from binding to the cell surface receptor in the nose. That way the heparin spray should block COVID-19 infection in the nose from occurring.
How safe is my data?
Your data is safely stored on a server in Australia, in a format that cannot be linked directly to your identity. Your data will only be used for the purposes of the research and will not be shared with anyone else. The de-identified data is held for 7 years in accordance with statutory requirements for the conduct of clinical research trials in Australia.
What will happen if the trial is a success?
If the trial is a success, intranasal heparin will be able to be used safely as a preventive measure to reduce the risk of COVID-19 spread. Heparin self-administered via the nasal spray three times per day, including for example, prior to and following potential exposure in public places, crowded venues, public transport and airline travel, may provide a degree of protection against COVID-19 infection.
Who are the research team?
The team comprises clinicians, with expertise in the care of persons with COVID-19 infection from Northern Hospital, and haematologists and clinical trials experts from Murdoch Children’s Research Institute, along with experts in pharmacology and pharmacy from Monash Institute of Pharmaceutical Science and University of Melbourne Department of Pharmacology and virology experts from the Peter Doherty Institute. All the research team Principal Investigators have a current certificate of good practice for the conduct of clinical research trials, in accordance with the requirements of their parent institution.
Is there a Steering Committee overseeing the trial?
The Steering Committee overseeing the research includes experienced researchers from Murdoch Children’s Research Institute, and Northern Hospital with experts from Monash Institute of Pharmaceutical Science and University of Melbourne Department of Pharmacology, the Doherty Institute, University of Melbourne, plus clinicians from Royal Melbourne, St Vincent’s and Western Hospital, consumer representatives and external respiratory experts from University of Oxford.
Who is funding the study?
The Victorian Government is funding the study.
Clinical Trial Registration and Human Research Ethics Approval
The INHERIT trial has approval to proceed under the auspices of the Human Research Ethics Committee from St Vincent’s Hospital Melbourne, and a Site-Specific Agreement with the Northern Hospital. The IINHERIT trial is registered on the clinicaltrials.gov website (ClinicalTrials.gov Identifier: NCT05204550).
Who can I contact for more information about the trial?
For further information about the conduct of the trial, please contact: INHERIT.Study@nh.org.au.
