ITPP as an adjunctive treatment for progressive respiratory failure in COVID-19 and other pulmonary parenchymal infections - a randomized, double-blind, non-commercial phase II clinical trial [BREATH2]
This clinical trial, called BREATH2, is investigating a new treatment named ITPP for people suffering from severe lung infections, including COVID-19. These infections can make it very hard to breathe. The study wants to find out if adding ITPP to a patient's existing treatment helps improve their breathing. Researchers will measure different things in the blood to see if breathing gets better. They will also carefully check if ITPP is safe and if patients can use it without too many side effects. This is a Phase II study, meaning it's still an early stage of testing, focusing on whether a treatment works and in what doses, after initial safety tests. The goal is to find better ways to help people with serious breathing problems. Participants will be chosen randomly to receive either ITPP or a dummy treatment, and neither they nor their doctors will know which one they are getting.
At a glance
What is this study about?
When you have a severe lung infection, like COVID-19 or other similar illnesses, your lungs can become very damaged, making it extremely difficult to breathe. This is called respiratory failure, and it can be a very serious condition. Doctors are always looking for new and better ways to help people recover and breathe more easily.
This study is testing a new medicine called ITPP. It's hoped that ITPP might help the lungs work better when added to the treatments patients already receive. Think of it like giving your lungs a boost to help them recover. The main goal of the study is to see if taking ITPP helps improve how well your lungs use oxygen, which doctors can measure through simple blood tests. If successful, this could mean better recovery and a reduced need for intensive breathing support for people with severe lung infections.
This is a 'Phase II' study, which means it's an important step in developing new medicines. In this stage, researchers are looking closely at how effective the treatment is and making sure it's safe for people to use. It's common in these types of studies for some people to receive the new medicine and others to receive a 'dummy' treatment (like a salt water injection) so that doctors can accurately compare the effects without bias. Neither you nor your doctor will know which one you are getting, to keep the results fair and unbiased.
Key takeaways
- This study is for people with severe lung infections like COVID-19, who are struggling to breathe.
- It is testing a new treatment called ITPP to see if it helps improve breathing.
- Participants will receive either ITPP or a dummy treatment alongside their usual care.
- Researchers will closely monitor breathing and health to check the treatment's effectiveness and safety.
- This is an early-stage study (Phase II) looking for better ways to help patients.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have serious lung infections, such as COVID-19, that are making it hard for them to breathe.
There might be other reasons why someone can't join, which a study doctor would discuss with you. These reasons are put in place to ensure your safety and to make sure the study results are as clear and helpful as possible.
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 or older?
- Do you have a serious lung infection (like COVID-19)?
- Are you currently having trouble breathing due to your lung infection?
- Are you prepared to receive potential treatment through injection?
What does participation involve?
If you decide to take part in this study, you will likely receive the study treatment, ITPP, or a dummy treatment through an injection. This will be given alongside the usual care you would receive for your lung infection. You would have regular check-ups, which might include blood tests, to see how your breathing is improving and to make sure you are feeling okay. The study team will explain how often these check-ups will be and how long the treatment will last. They will closely monitor your health throughout your time in the study. You'll be part of the care for as long as needed to fully assess the treatment, which the study team will explain in detail.
Potential risks and benefits
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Common questions
What is ITPP?
ITPP is a new treatment being tested in this study. It's hoped that it will help people with serious lung infections breathe better.
What does 'adjunctive treatment' mean?
It means the ITPP treatment would be given in addition to the treatments you are already receiving for your lung infection, not instead of them.
Why might I get a 'dummy treatment'?
Getting a dummy treatment (like a salt water injection) helps researchers fairly compare the new treatment's effects. It's a standard practice in medical studies.
Will I know if I'm getting ITPP or the dummy treatment?
No, neither you nor your doctors will know which one you are receiving. This is called 'double-blind' and ensures the study results are unbiased.
What is a 'Phase II' clinical trial?
Phase II means it's an early but important stage of testing. Researchers are looking to see if the treatment works and is safe in a larger group of patients after initial safety checks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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