CompletedInterventional

Clinical trial for the treatment of COVID-19 and COVID-like illness in primary care

Most people recover from COVID-19 and similar chest infections at home, but some can become very unwell. This trial investigates whether simple nasal sprays can help adults recover faster, reduce the severity of their symptoms, and stop them needing hospital treatment. Adults aged 18 and older who have developed cold- or flu-like symptoms within the last few days may be eligible. Participants are placed by chance into groups. One group receives standard care alone, while others receive standard care plus a nasal spray. The sprays tested include a nitric oxide spray, a trial medicine called LTX-109, a salt-water spray, or an inactive dummy spray. Taking part involves using the spray for a few days, keeping a symptom diary for 28 days, taking swab samples at home, and completing a follow-up check after three months. Taking part is completely voluntary.

At a glance

Status

Completed

Sponsor

University Medical Center Utrecht

Enrolment target

1,700

Start

03 Oct 2024

Estimated completion

31 May 2026

Respiratory tract infections, COVID-19, and COVID-like illness

What is this study about?

Coughs, colds, and COVID-19 are very common, especially during the winter months. While most people manage their symptoms at home and get better on their own, some develop severe chest complications that require hospital treatment. Finding simple, low-cost treatments that people can start at home early in their illness could help patients recover more quickly and take pressure off the NHS.

This clinical study aims to find out whether medicated nasal sprays can stop viral respiratory infections from getting worse. Because viruses like COVID-19 usually enter and multiply in the nose and throat, treating the infection directly in the nasal passages might clear the virus more quickly and soothe early symptoms.

The trial is being run across several European countries, including the UK, in collaboration with the University of Oxford. Researchers are testing different nasal sprays alongside normal care to see which ones work best and ensure they are safe and easy for patients to use at home.

Key takeaways

Tests whether simple nasal sprays can speed up recovery from COVID-19 and similar illnesses.
Open to adults aged 18 and over with recent cold, flu, or COVID-like symptoms.
Involves using a nasal spray for 3 to 7 days and completing a 28-day symptom diary.
Participants take swab samples at home and store them temporarily in a freezer.
Taking part is voluntary and does not replace your standard GP or NHS care.

Who may be eligible?

You may be able to join this study if you are 18 years of age or older and have recently developed symptoms of COVID-19 or a similar viral chest infection. A doctor or healthcare worker will check whether your illness is likely caused by a respiratory virus.

To take part, you must have at least one breathing symptom (such as a cough, sore throat, blocked nose, or shortness of breath) and at least one general body symptom (such as a fever, chills, headache, muscle aches, extreme tiredness, or loss of taste or smell). Your symptoms must have started within a specific number of days before joining.

You also need to be willing to follow the study steps, which include filling in a daily symptom diary and having access to a home freezer to store swab samples until they are collected.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I currently have at least one respiratory symptom (e.g., cough, sore throat, or runny nose).
I currently have at least one body symptom (e.g., fever, tiredness, body aches, or loss of smell).
My illness started only a few days ago.
I have access to a freezer at home to store swab samples.

Answer every question to see your result.

What does participation involve?

If you take part, a computer will assign you by chance to a treatment group. You will either receive your usual medical care on its own, or usual care along with a nasal spray. Depending on your group, you will spray the medicine into your nose between three and six times a day for three to seven days. Some sprays contain active ingredients, while others are plain salt water or an inactive dummy spray.

You will keep a daily diary of your symptoms for 28 days. You will also take a few combined nose and throat swabs at home on specific days and keep them in your home freezer until they can be tested. Study staff will contact you by telephone around day 28 to 35 if any diary information is missing. Finally, you will complete a brief check-in by phone or online survey at three months to see how you are doing.

Potential risks and benefits

You may benefit from taking part if the nasal spray helps relieve your symptoms or helps you recover faster, though this cannot be guaranteed. Your participation will also help doctors learn how to treat viral illnesses better in the future. The main risks include possible mild side effects from the nasal sprays, such as temporary nasal irritation, and brief discomfort while taking nose and throat swabs. Taking part will also take up some of your personal time. Joining is entirely your choice, and you are free to leave the trial at any time without your standard NHS care being affected.

Locations (42)

Nuffield Department of Primary Care Health Sciences, University of Oxford
City only
Oxford, England
Honiton Surgery
Approximate
Honiton, England
Melrose Surgery
City only
Reading, England
Bovey Tracey and Chudleigh Medical Practice
City only
Bovey Tracey, England
Banbury Cross Health Centre
Approximate
Banbury, England
St. Bartholemews Medical Centre
Unverified
Oxford, England
Bicester Health Centre
Unverified
Bicester, England
Gosford Hill Medical Centre
Unverified
Kidlington, England
The White Horse Medical Practice
Unverified
Faringdon, England
Hedena Health
Unverified
Oxford, England
Huisartsenpraktijk Pairon Muyldermans
Unverified
Schilde, Belgium
Artsenpraktijk Waarloos
Unverified
Kontich, Belgium

Common questions

Do I have to pay for the study nasal spray?

No. All study medications, swabs, and trial materials are provided completely free of charge.

Can I choose which nasal spray I receive?

No. A computer system selects your treatment group at random to make sure the trial results are completely fair and unbiased.

Will I still receive my normal medicines?

Yes. Every participant receives standard medical care. The study treatment is given in addition to whatever normal care your doctor recommends.

Why do I need a freezer at home?

The nose and throat swabs you collect at home need to be kept frozen to preserve the viral samples before they are sent to the laboratory for testing.

What happens if my symptoms get worse?

Your safety comes first. If your condition worsens at any point, you should contact your GP surgery, call NHS 111, or seek emergency medical care as usual.

How to find out more

Lina Gurskaite

lina.gurskaite@ecraid.eu +31 (0)631118658 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.