A phase 2, two-part study to assess the safety, antiviral biomarker responses, and efficacy of inhaled SNG001 for the treatment of patients with a confirmed respiratory virus infection undergoing invasive mechanical ventilation
This study is investigating a new inhaled treatment called SNG001. It's for adult patients in hospital who have a serious lung infection caused by a virus and need a breathing machine (ventilator). The main goals are to check if SNG001 is safe and how well people tolerate it. We also want to see if it helps the body fight the virus and improves recovery, for example, by helping people come off the breathing machine sooner. Some patients will receive SNG001, while others will receive a dummy medicine called a placebo to compare its effects. This is a Phase 2 study, meaning it's still in the earlier stages of testing to get more information about the medicine's safety and how it works.
At a glance
What is this study about?
This research study is about a new way to treat serious lung infections caused by viruses. When these infections become severe, they can cause a lot of problems in the lungs, and some people might need help from a breathing machine, also known as a ventilator, in intensive care. The medicine we are testing is called SNG001, and it's given as an inhalation, which means you breathe it in, similar to how some people use inhalers for asthma. The idea behind SNG001 is to help your body's immune system fight off the virus more effectively.
The study is split into two main parts. The first part focuses mainly on safety, making sure that SNG001 doesn't cause too many side effects, especially problems with breathing or the heart. The second, larger part aims to understand how well SNG001 works. We'll be looking at important things like whether it helps people recover better, spend less time on a breathing machine, or leave the hospital sooner. We'll also be comparing it to a "placebo," which looks exactly like SNG001 but doesn't contain the active medicine. This helps us understand if any improvements are truly due to SNG001 or if they would have happened anyway.
By doing this study, we hope to find out if SNG001 could be a helpful treatment option for people with severe viral lung infections who need intensive care. This kind of research is very important because it helps doctors find better ways to care for patients and improve their chances of recovery.
Key takeaways
- This study is testing an inhaled medicine (SNG001) for severe viral lung infections.
- It's for adults who need a breathing machine in hospital.
- The study checks for safety and how well the medicine helps people recover.
- Some participants will get the actual medicine, others a placebo.
- Participation involves close monitoring during your hospital stay and for 28 days after joining.
Who may be eligible?
To join this study, people must be adults (18 years old or older). While the study is open to both men and women, there are specific medical reasons someone might be able or unable to take part.
Generally, participants need to have a confirmed virus infection in their lungs and require a breathing machine (ventilator) to help them breathe. There will also be other health checks to make sure the study is a good fit and safe for each person.
If you or a loved one meet these general requirements and are in hospital with a severe viral lung infection, the medical team will be able to tell you if you might be suitable for this study.
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 18 years old or older?
- Do you have a confirmed viral infection in your lungs?
- Are you currently in hospital needing a breathing machine (ventilator)?
- Have your doctors identified you as potentially suitable for this type of research?
What does participation involve?
If you join this study, you will receive either the study medicine (SNG001) or a placebo (a dummy medicine). Both are given by inhaling them. The medical team will closely monitor your health throughout your hospital stay. They will regularly check how you are breathing, your heart, and other important health signs. They will also take samples, like blood or samples from your airways, to see how your body is responding to the treatment and fighting the virus. This monitoring and treatment will continue for a period, and then your health will be checked for a total of 28 days after you join the study, even if you have already left the intensive care unit or gone home.
Potential risks and benefits
Locations (4)
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedBelgium
Common questions
What is SNG001?
SNG001 is an investigational medicine being tested to treat serious viral lung infections. It's given by breathing it in.
What's a 'breathing machine'?
A breathing machine, or ventilator, is a device that helps you breathe when your lungs are too sick to do it on their own, often used in intensive care.
What is a placebo?
A placebo is a dummy medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is actually working.
Why is this study being done?
This study aims to see if SNG001 is safe and helps people with severe viral lung infections recover better, especially those needing breathing support.
Can I choose to receive SNG001?
No, whether you receive SNG001 or the placebo is decided randomly, like flipping a coin. You won't know which one you're getting.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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