RecruitingPhase IIInterventional

Precision medicine Adaptive Network platform Trial in Hypoxaemic acutE respiratory failuRe

This research is looking for better treatments for a serious lung condition called Acute Respiratory Distress Syndrome (ARDS), which affects many people in intensive care. ARDS makes it very hard to breathe because of inflammation in the lungs. Currently, there aren't many proven medicines to help. We're testing two medicines, simvastatin and baricitinib, in a new type of study called a 'platform trial'. This allows us to test several treatments at once and add new ones as we learn more. By understanding how different patients respond, we aim to find effective treatments quicker, improving care for people over 18 who are critically ill with ARDS.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Imperial College London

Enrolment target

1,563

Start

31 May 2025

Estimated completion

31 May 2029

Critical illnesses including acute respiratory disease syndrome and pandemic infection

What is this study about?

When you're very poorly in hospital, especially in intensive care, you might develop a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). This condition essentially means your lungs become inflamed and struggle to get enough oxygen into your body, making breathing very difficult. It's a common and serious problem, and sadly, it can lead to severe health issues or even death. Right now, there aren't many specific medications that have been proven to treat ARDS effectively.

Researchers have found that ARDS isn't the same for everyone; there seem to be different types, or 'subgroups,' of patients. We believe that certain treatments might work better for one subgroup than another. The goal of this study is to figure out which treatments are best for which patients. We're running a special kind of study called a 'platform trial' which allows us to test several potential treatments at the same time and learn quickly what works and what doesn't. This way, we hope to discover effective treatments faster and help more people.

We will be testing two medicines, simvastatin and baricitinib, to see if they can help people with ARDS. We want to understand how these medicines affect different types of patients. Our aim is to find ways to treat ARDS more successfully in the future, improving the health and recovery of many people.

Key takeaways

This study aims to find better treatments for a severe lung condition called ARDS.
It involves testing two existing medicines, simvastatin and baricitinib, in a new way.
The study takes place in intensive care units, for critically ill adult patients.
Researchers will follow up on patients for up to a year after joining.
Results from this study could help many future patients with ARDS.

Who may be eligible?

This study is looking for adults who are already very unwell in hospital, specifically in intensive care, and are suffering from ARDS. ARDS is a lung condition that makes it hard to breathe, often requiring help from a machine.

You might be able to take part if you are 18 years old or older and have ARDS, or a similar condition linked to a widespread infection or pandemic. The doctors will check specific signs in your breathing and chest scans to confirm if you meet the criteria for ARDS. You cannot have been diagnosed with ARDS more than 48 hours before joining the study.

Key things that would prevent you from joining include being under 18, if treatment to keep you alive is planned to be stopped within 24 hours, if you've already been in this specific PANTHER study in the last year, or if you or your representative have decided not to take part.

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?
Are you currently in hospital with ARDS or a severe lung condition linked to a widespread infection?
Was your ARDS diagnosed within the last 48 hours?
Have you NOT been part of this specific PANTHER study before in the last year?

Answer every question to see your result.

What does participation involve?

If you are eligible, and a decision is made for you to join the study, you would be randomly assigned to receive one of two study medicines (simvastatin or baricitinib) or to receive the usual care given for ARDS. The research team will regularly check on your health and progress during your stay in intensive care and until you leave the hospital.

Once you're home from the hospital, the team will get in touch with you at 3 months and again at 6 months after you joined the study. They will ask you to complete some questionnaires to understand your quality of life and how your memory and thinking skills are doing. Your overall health status, including whether you are still alive, will also be checked through your medical records 90 days and one year after you started the study. This helps us understand the lasting effects of the treatments.

Potential risks and benefits

There might not be any direct benefits to you personally from taking part in this study. However, the information we gain will be very valuable and could help doctors treat future patients with ARDS more effectively and successfully. ARDS is a life-threatening condition, and the study is designed to start treatment as quickly as possible, as earlier treatment may be more helpful. Because you'll be very unwell when joining, you might not be able to give consent initially, so your family or a professional will be asked. You can, however, decide to stop participating at any time. All patients in intensive care are closely monitored, and additional care for the study will fit into this routine.

Locations (1)

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

Not provided at time of registration
Unverified
United Kingdom

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a serious lung condition that causes your lungs to become inflamed, making it very difficult to breathe without help.

What medicines are being tested?

We are testing two medicines: simvastatin and baricitinib. We want to see if these medicines can help people recover from ARDS.

What is a 'platform trial'?

It's a special type of study that allows us to test several treatments at the same time and adapt as we learn more, helping us find effective treatments quicker.

Who is funding this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

Will I have to pay to take part?

No, you will not have to pay to take part in this study. All costs associated with the study treatments and assessments are covered by the research grant.

How to find out more

Daniel McAuley

d.f.mcauley@qub.ac.uk +44 (0)28 90 976385 Official trial record

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