COVID Trial at Home
Clinical trial of a new inhaled treatment (SNG001) for coronavirus infection
Thank you very much for your interest in taking part in this trial. Unfortunately, recruitment for this trial has closed as we have now reached our enrolment target.
You may be eligible to take part in the University of Oxford's PRINCIPLE trial, which is investigating further treatments for patients with possible COVID-19.
If you are interested in the PRINCIPLE trial, please visit https://secure.phc.ox.ac.uk/synairgen to see if you are eligible to take part, or contact the PRINCIPLE trial team on: [email protected] or Telephone 0800 138 0880
How do I join the trial?
1 of 5To join the trial you’ll first need to answer ten questions to assess your eligibility. You can start this now by clicking the blue, 'I would like to join the trial', button.
2 of 5If your answers to those ten questions meet the criteria, then you’ll be asked to enter your personal details to register yourself.
3 of 5You will have a video call with a trial doctor who will explain the trial and go through a patient information sheet with you. This will give you more information about the trial, and the doctor will be able to answer any queries that you may have.
4 of 5The trial doctor will then ask you questions about your health to make sure that you are eligible, and confirm your consent to take part in the trial.
5 of 5At this point, if you do not already have a positive coronavirus swab result, you will need to be tested to confirm whether your symptoms are due to COVID-19. You will either require an NHS test swab or we will provide you with a swab kit, and a trial nurse will guide you through how to use the test swab via video call. The swab will then be sent to a lab for analysis.
- If the test shows that you are infected with coronavirus, you will be randomly put into one of two treatment groups: one group will be given SNG001 and the other group will be given a placebo (a ‘dummy treatment’, which looks like the trial medicine but does not contain SNG001). If the test is negative a trial nurse will let you know, and you will not be able to enter the trial at this time.
- The trial medication will be administered as an aerosol via a handheld nebuliser. The trial nurse will train you on how to take the trial medication via video call. You will take a dose of trial medication once a day for 14 days.
- A trial doctor or nurse will contact you once a day, via video call, to help you with taking the trial medication. They will also ask you questions about how you are feeling, and help you to measure your pulse, oxygen levels and temperature using simple equipment that will be provided to you.
- The day after your final treatment dose, you will have another video call with a trial doctor or nurse and be asked questions about your response to treatment, including assessing any side effects. Two weeks after your final treatment dose, you will have your final video call with a trial doctor or nurse and be asked questions about how you are feeling.
- For more information, please read the Patient Information Sheet. If you would like to join the trial, please click the “I would like to join this trial” button below. If you encounter any problems registering for the trial, please contact us on [email protected] or 0330 133 2870.
The coronavirus infection known as COVID-19 is a major threat to health around the world. There is an urgent need to find new treatments that prevent and/or treat the respiratory tract illness caused by the coronavirus. The purpose of this trial is to test an inhaled drug called SNG001 (the trial medication) in patients with confirmed COVID-19.
SNG001 contains Interferon-β which is a protein that occurs naturally in the body. One of its functions is to combat viruses. Recent research has suggested that Interferon-β might protect the cells in the lungs from cold and flu viruses in vulnerable patients.
There is evidence that older people and people with some chronic health conditions have poorer Interferon-β responses, and also that the virus that causes COVID-19 suppresses Interferon-β production by cells in the body.
It is hoped that SNG001, an inhaled Interferon-β delivered via a nebuliser (a machine that helps you to breathe in a medicine as a mist through a mouthpiece), will boost the lungs’ antiviral defences and help prevent a deterioration in lung symptoms in patients with COVID-19.
SNG001 inhalation has been well tolerated by over 200 patients with asthma or chronic bronchitis, many of whom also had a cold virus at the time of the treatment.
The trial will be conducted in your home with guidance provided by healthcare professionals via video calls.
You may take part in this trial if you have developed COVID-19 symptoms in the past 7 days and are considered to be more susceptible to complications of COVID-19, based on your age and/or other illnesses you may have.
It is up to you if you choose to take part in the trial or not. If you do decide to take part, you will still be free to withdraw at any time, without giving a reason, and without your medical care being affected.
This trial is sponsored and organised by Synairgen Research Limited, a drug discovery and development company specialising in viral lung infections. The Southampton Clinical Trials Unit, as part of the University of Southampton, are overseeing the conduct of the trial.
The trial has been approved by Haydock Research Ethics Committee (reference: 20/NW/0168); Health Research Authority (IRAS: 281317); and Medicines and Health products Regulatory Agency.
The trial is registered on:
NIHR ISRCTN registry: http://www.isrctn.com/ISRCTN14241621
Clinicaltrials.gov registry: NCT04385095
EudraCT Reference: 2020-001023-14