RecruitingPHASE2INTERVENTIONAL

Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection

This research study is testing a new inhaled medicine called SNG001 for people who are in intensive care. They need help breathing due to a severe lung infection caused by a virus (like flu or coronavirus). The study wants to find out if SNG001 is safe to use and if it can help patients clear the virus faster and reduce the risk of death. Participants will receive either SNG001 or a dummy medicine (placebo), alongside their usual hospital care. The study has two parts: the first part mainly checks for safety in patients aged 50 and over, and the second part focuses on how well SNG001 works in a wider group of adults, including those with weaker immune systems.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Synairgen Research Ltd.

Enrolment target

550

Start

02 Sep 2025

Estimated completion

01 May 2027

Viral Pneumonia

What is this study about?

Imagine you're very sick in hospital because of a severe lung infection from a virus, and you need a machine to help you breathe. This study is looking into a new inhaled medicine, called SNG001, to see if it can help people like you get better. We already know that SNG001 has been studied in different illnesses, but this trial specifically focuses on people who are very unwell with a viral chest infection.

The main idea is to see if SNG001 can help your body fight off the virus more effectively and get you off the breathing machine sooner. We also want to make sure it's safe to use in such a serious situation. Some people in the study will get SNG001, and others will get a 'dummy' treatment (called a placebo) alongside the normal care everyone receives in the hospital. This allows us to compare and see if SNG001 makes a real difference.

The study is split into two phases. In the first phase, we'll mostly be checking SNG001's safety for patients aged 50 and older. Once we're confident about safety, the second phase will focus more on how well SNG001 works to help patients recover, including adults aged 18 and over, especially those with certain health conditions that might make them more vulnerable.

Key takeaways

This study tests an inhaled medicine (SNG001) for severe viral chest infections.
It aims to make breathing machine patients recover faster and more safely.
Patients get either SNG001 or a placebo, plus standard hospital care.
Initial focus is on safety for patients 50+, then effectiveness for a wider group.
Treatment lasts up to 14 days while in hospital and on a breathing machine.
Your medical care will not be affected if you choose not to join or withdraw.

Who may be eligible?

To join the first part of this study, you would need to be at least 50 years old and in intensive care, needing a breathing machine because of a confirmed viral chest infection (like flu, RSV, or coronavirus). The first dose of the study medicine must be given within 48 hours of you starting on the breathing machine. If you are a woman who could become pregnant, you would need to have a negative pregnancy test.

There are also some reasons why someone couldn't join. For example, if it's expected you'll be taken off the breathing machine very soon, or if you have a life expectancy of less than 24 hours. Certain serious existing health conditions, such as severe heart or liver failure, or if you've had a lung transplant, would also mean you couldn't take part.

Also, if you have certain other infections like tuberculosis or a fungal infection, or if you're allergic to the study medicine, you wouldn't be able to participate. Needing certain types of breathing support or having a tracheostomy (a breathing tube in your neck) would also stop you from joining.

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.

Are you 50 years or older (for Part 1)?
Are you currently in intensive care and need a breathing machine?
Do you have a confirmed viral chest infection (e.g., flu, COVID-19, RSV)?
Have you been on the breathing machine for less than 48 hours?
Do you *not* have severe heart or liver failure?
Are you *not* expected to be taken off the breathing machine very soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new inhaled medicine SNG001 or a dummy medicine (placebo) once a day for up to 14 days, all while you are in the hospital. This would be in addition to all the regular care you would normally receive from the hospital staff. Doctors and nurses would closely monitor your health, take regular blood and other samples, and check how your breathing is improving. You would be in the hospital for the duration of the treatment and monitoring. After you leave the hospital, there might be some follow-up checks to see how you are doing, but the main part of the study happens while you are an inpatient.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit of this study is that SNG001 might help you recover faster from your viral chest infection, clear the virus more quickly, and generally improve your condition. However, it's also possible that SNG001 may not help, or you might experience side effects, just like with any medicine. We don't know the full effects yet, which is why we are doing the study. Researchers will closely watch you for any problems. If you decide to join, you are free to leave the study at any time without it affecting your usual medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California - Davis
Verified postcode
Sacramento, United States· Not yet recruiting
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Verified postcode
Torrance, United States· Recruiting
NCH Pulmonary Critical Care
Verified postcode
Naples, United States· Not yet recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
Snake River Research, PLLC
Verified postcode
Idaho Falls, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
Sinai-Grace Hospital
Verified postcode
Detroit, United States· Recruiting
William Beaumont Hospital
Verified postcode
Royal Oak, United States· Recruiting
Mayo Clinic - Rochester
Verified postcode
Rochester, United States· Recruiting
Washington University in St. Louis
Verified postcode
St Louis, United States· Recruiting
VA Western New York Healthcare system
Verified postcode
Buffalo, United States· Not yet recruiting
NYU Langone Tisch Hospital
Verified postcode
New York, United States· Not yet recruiting

Common questions

What is a 'breathing machine'?

A breathing machine, or ventilator, is a medical device that helps you breathe when your lungs are very unwell. It provides oxygen and helps push air in and out of your lungs.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps us see if the new medicine really works better than no treatment at all.

What kind of viral infections are being studied?

The study includes serious infections from common viruses like flu (Influenza A or B), RSV, rhinovirus, and different types of coronaviruses, including SARS-CoV-2 (which causes COVID-19).

Will I know if I'm getting the real medicine or the placebo?

Neither you nor your doctors will know if you are receiving SNG001 or the placebo during the study. This is called 'blinding' and helps make sure the results are fair and unbiased.

How long will I be on the study medicine?

If you are in the study, you would receive the inhaled medicine once a day for up to 14 days, or until you no longer need the breathing machine, whichever comes first.

How to find out more

Sophie Hemmings

submissions@synairgen.com +442380512800 Official trial record

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