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RecruitingPhase IIInterventional

A clinical trial of nebulized (fine spray) surfactant (chemical compounds that decrease the surface tension between two liquids) for the treatment of severe COVID-19 and viral pneumonia in adults (COVSurf)

We're investigating a new treatment for severe viral pneumonia, including COVID-19, in hospitalised adults who need breathing support. Our lungs naturally produce a fluid called surfactant that helps them work properly. In severe lung conditions, this fluid might not work as it should. This study aims to see if giving a special type of surfactant directly into the lungs through a fine spray (nebuliser) can help improve lung function and potentially reduce the time people spend on a ventilator. We're also trying to find the best way to give this treatment. Participants will receive either the study treatment or standard care, and their progress will be carefully monitored.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
5
Start
30 Jul 2024
Estimated completion
30 Jul 2027

What is this study about?

Our lungs have a natural, slippery fluid called surfactant. Think of it like a very thin layer inside your lungs that helps them stay open and makes it easier for you to breathe. When someone gets severe viral pneumonia, including infections like COVID-19, this vital fluid might not work as well as it should. This can make breathing very difficult and often means people need machines (ventilators) to help them breathe.

This study, called COVSurf, is looking into whether giving extra surfactant to people with severe viral pneumonia can help. The idea is that by replacing or boosting this natural lung fluid, we might be able to improve how well the lungs work. The surfactant will be given as a very fine spray, almost like a mist, directly into the lungs through a special device.

We want to find out two main things: first, if giving this surfactant actually helps improve breathing and lung function in patients. Second, if it does help, we want to figure out the best amount and timing for giving the treatment. This research could potentially help people recover faster and spend less time on a ventilator.

Key takeaways

  • A new study testing a lung fluid called surfactant for severe pneumonia and COVID-19.
  • Aims to improve breathing and potentially reduce time on a breathing machine.
  • Treatment is given as a fine spray directly into the lungs.
  • Participants are hospitalised adults needing breathing support.
  • Potential benefits include better lung function; risks are carefully managed.
  • The study tests different amounts of the treatment to find the best approach.

Who may be eligible?

This study is looking for adults aged 18 and over who are currently in hospital with viral pneumonia, including COVID-19, and need help breathing with a machine called an endotracheal intubation (which means a tube is placed in your windpipe to connect to a ventilator).

However, some people might not be able to join. This includes if you are expected to pass away within 24 hours, have known allergies to surfactant, or have certain serious health conditions affecting your kidneys or liver. We also can't include pregnant people or those who have recently taken part in another study that might affect this one. Your doctor will carefully check if this study is suitable for you.

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.

  1. Are you 18 years old or older?
  2. Are you currently in hospital with viral pneumonia or COVID-19?
  3. Do you need a breathing machine (ventilator) with a tube in your windpipe?
  4. Are you able to agree to take part, or is there a legal representative who can do so?
  5. Do you have severe kidney or liver disease (or are on dialysis)? (If yes, you may not be able to join)
Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be assigned by chance to one of two groups. Two out of every five participants will continue to receive the usual care without the study treatment, while three out of every five will receive the special surfactant treatment. Those receiving the treatment will be given it as a fine spray through a nebuliser at the start, then again 8 hours later, and a final time 24 hours after the first dose. Because patients will already be in hospital and on a ventilator, no extra hospital visits or changes to your daily routine are expected.

Throughout your time in hospital, the research team will keep a close eye on your breathing and how well your lungs are working, particularly how much oxygen you are getting. They will also collect routine blood and lung fluid samples that would already be part of your hospital care. The study is expected to run from April 2025 to August 2027.

Potential risks and benefits

A potential benefit of joining this study is that receiving the surfactant treatment might help improve your lung function, possibly leading to a shorter time spent on a breathing machine (ventilator). However, there are also some potential risks. These can include issues like reduced breathing or not getting enough oxygen, or, in rare cases, a collapsed lung due to changes in how your lungs respond to the treatment. There's also a small chance of irritation in the airways or a very low risk of introducing other infections. The research team has taken steps to control and monitor these risks very carefully using advanced equipment. Remember, you can choose to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospital Southampton
    City only
    Southampton, England

Common questions

What is surfactant?

Surfactant is a natural fluid in your lungs that helps them stay open and makes breathing easier. This study will give a similar fluid as a medicine.

How will the treatment be given?

The treatment will be given as a very fine spray, like a mist, directly into your lungs through a device called a nebuliser, while you are on a ventilator.

Will I know if I'm getting the treatment?

No, you will be randomly assigned to either receive the treatment or standard care, and neither you nor your doctors will know which group you are in, to keep the study fair.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and this will not affect your medical care.

Who is paying for this study?

This study is being funded by the Gates Family Foundation.

How to find out more

Danny Pratt

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

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