RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

This important study is called a 'Phase 3' trial, which means it’s one of the final steps before a new medicine might be approved. Doctors are testing a drug called Tozorakimab. It's for people who are in hospital because of a viral lung infection and need oxygen to help them breathe. The main aim is to find out if Tozorakimab, when given alongside standard care, can prevent patients from getting much worse. This includes stopping them from needing intensive care with a breathing machine (called IMV) or a heart-lung bypass machine (called ECMO), or even preventing death. Half the participants will get Tozorakimab, and the other half will get a dummy medicine (placebo), so we can fairly compare the results.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

2,870

Start

13 Dec 2022

Estimated completion

19 Jun 2026

Viral Lung Infection and Acute Respiratory Failure

What is this study about?

This research is looking into a new medicine called Tozorakimab for people who are very unwell with a lung infection caused by a virus. When you have a severe lung infection, your lungs can struggle to get enough oxygen into your blood. This often means you need to stay in hospital and be given extra oxygen to help you breathe more easily. The doctors and researchers want to see if Tozorakimab can prevent people from getting sicker and needing more intensive treatments.

The main goal is to find out if this new medicine can stop patients from needing a breathing machine (Intensive Mechanical Ventilation or IMV) or a very advanced life support system called ECMO (Extracorporeal Membrane Oxygenation). These treatments are used when your lungs are struggling badly. The study also aims to see if Tozorakimab can help reduce the risk of death for people with these severe viral lung infections.

This is a 'Phase 3' study, which means it's a big, final step in testing a new medicine. It helps doctors understand if Tozorakimab is safe and effective when compared to what usually happens (standard hospital care, which here will include a dummy medicine called a placebo for comparison). The information from this study will help decide if Tozorakimab could become a new treatment option for people with serious viral lung infections.

Key takeaways

This study is testing a new medicine called Tozorakimab for severe viral lung infections.
It aims to prevent patients from needing breathing machines or advanced life support.
You must be in hospital and need extra oxygen to be considered.
Participation involves receiving either the new medicine or a dummy medicine.
The study will closely monitor your health and recovery.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must be in hospital with a lung infection caused by a virus and need extra oxygen because your oxygen levels are low. Doctors will check your oxygen levels, and they might also look at X-rays or scans of your chest to confirm the lung infection.

There are some reasons why you might not be able to join. For example, if your low oxygen is mainly caused by something other than a lung infection, or if you already have a very specific type of fungal or parasitic lung infection. Also, you can't join if you're already on a breathing machine or ECMO before the study begins. If doctors think a bacterial infection is the main problem, you might not be suitable, even though some bacterial infections are allowed alongside the viral one.

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.

Am I 18 years old or older?
Am I currently in hospital with a lung infection caused by a virus?
Do I need extra oxygen because my oxygen levels are low?
Am I NOT currently on a breathing machine or an ECMO machine?
Does my doctor think my breathing problems are mainly due to a viral lung infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll either receive the study medicine, Tozorakimab, or a dummy medicine (placebo), both given alongside your usual hospital care. Neither you nor your doctor will know which one you are receiving. You'll have regular checks by the study team, which will include blood tests, monitoring your breathing and oxygen levels, and perhaps chest X-rays or scans. You'll be closely watched throughout your hospital stay and for a period after you go home to see how the medicine has affected your recovery. The total duration of your participation in the study, including follow-up after leaving hospital, will be explained in full detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new medicine that could help improve your condition, or you might help doctors learn more about viral lung infections. However, there's also a chance you could receive the dummy medicine. All medicines can have side effects, and some might be serious, so the study team will monitor you very closely for any changes in your health. You'll be given more detailed information about possible side effects before you decide to join. Remember, taking part is completely your choice, and you can change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (451)

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

Research Site
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Mobile, United States· Recruiting
Research Site
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Phoenix, United States· Recruiting
Research Site
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Phoenix, United States· Recruiting
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Tucson, United States· Recruiting
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Chula Vista, United States· Recruiting
Research Site
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Fresno, United States· Recruiting
Research Site
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La Mesa, United States· Withdrawn
Research Site
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Los Angeles, United States· Recruiting
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Newport Beach, United States· Recruiting
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Torrance, United States· Recruiting
Research Site
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Colorado Springs, United States· Recruiting
Research Site
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Denver, United States· Withdrawn

Common questions

What is Tozorakimab?

Tozorakimab is a new medicine being tested to see if it can help people with severe viral lung infections.

Is this medicine approved for use?

No, it's an experimental medicine still being studied. That's why we’re doing this research.

Will I definitely get the new medicine?

You might get the new medicine or a dummy medicine called a placebo. It’s decided by chance, and neither you nor your doctor will know which one you receive.

What does 'viral lung infection' mean?

It means your lung infection is caused by a virus, like the flu or other common viruses, making it hard to breathe.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your usual medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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