Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy, and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment

This research is a Phase III clinical trial looking at a new medicine called Sipavibart (also known as AZD5156/AZD3152). The main goal is to find out if this medicine can effectively prevent COVID-19 infections before they happen, especially in people whose bodies can't fight off illnesses as well. We want to know if it's safe to use and how well it works compared to another medicine called Evusheld, or sometimes a placebo (a dummy medicine with no active ingredients). Researchers will be carefully checking for any side effects and how many people get COVID-19 while taking part in the study. The results will help us understand if Sipavibart could be a new way to protect vulnerable people from COVID-19.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

533

Start

11 Jul 2024

COVID-19

What is this study about?

This study is a Phase III clinical trial to see if a new medicine, called Sipavibart (also known as AZD5156/AZD3152), can help prevent COVID-19 in people who have a weakened immune system. People with weakened immune systems often struggle more to fight off infections, so preventing COVID-19 before it starts is really important for them. The study is comparing Sipavibart with an existing medicine called Evusheld, which is already used to protect some people from COVID-19, or with a placebo (a dummy treatment that contains no active medicine).

The main things researchers want to find out are how safe the new medicine is and how good it is at stopping people from getting sick with COVID-19. They will be carefully watching for any side effects and will count how many people get COVID-19 in each group. They are also interested in how well the medicine works against different types of the COVID-19 virus.

This type of study is called 'double-blind' and 'randomized'. 'Randomized' means that participants are put into treatment groups by chance, like flipping a coin. 'Double-blind' means that neither you nor your study doctor will know whether you are receiving the new medicine, Evusheld, or the placebo. This helps make sure the study results are as fair and unbiased as possible. The aim is to find effective new ways to protect people who are at higher risk from COVID-19.

Key takeaways

This study is testing a new medicine (Sipavibart) to prevent COVID-19.
It's for people with weakened immune systems who are at higher risk.
The new medicine is compared to an existing one (Evusheld) or a placebo (dummy treatment).
Its main goals are to check for safety and how well it prevents COVID-19.
Participants will receive injections and have regular check-ups.
You won't know which treatment you are receiving to keep the study fair.

Who may be eligible?

To join this study, you need to be an adult, 18 years of age or older. The study is open to both men and women.

Because this study is specifically looking at preventing COVID-19 in people with conditions that weaken their immune system, you would need to have such a condition to be considered. We are looking for people who haven't already had COVID-19 very recently and who are currently well enough to take part.

There might be other health requirements or medicines you are taking that would mean you couldn't join. The study team will discuss all these details with you to make sure it's the right choice.

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 health condition that weakens your immune system?
Are you generally healthy enough to take part in medical research?
Are you willing to attend regular clinic appointments and have blood tests?
Have you not had COVID-19 very recently (the study team will confirm exact timings)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine (Sipavibart, Evusheld, or a placebo) through injections. You wouldn't know which one you are getting. You would have regular visits to the clinic so the study team can check on your health, ask about any symptoms or side effects, and take blood samples. These visits are important to make sure the medicine is safe and working as intended.

The study would involve several follow-up visits and phone calls over a period of time, perhaps for many months, to monitor your health. They will collect information on any symptoms of COVID-19 you might develop and check for serious side effects. At each visit, the team will explain what will happen and answer any questions you have. The total time you would be involved in the study will be clearly explained by the research team.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of receiving a new medicine that could protect you from COVID-19, especially if you have a weakened immune system. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine might not work for you. You will be closely monitored by the study team, and you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Spain
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Unverified
France
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Unverified
Germany
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Unverified
Poland
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Unverified
Belgium
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Unverified
Denmark

Common questions

What is the new medicine being tested?

The new medicine is called Sipavibart, also known as AZD5156/AZD3152. It's designed to help prevent COVID-19.

Why are they studying people with weak immune systems?

People with weakened immune systems are often more vulnerable to severe COVID-19, so this study aims to find ways to protect them better.

Will I know if I'm getting the real medicine or a dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving. This helps make the study fair.

What does 'pre-exposure prophylaxis' mean?

It means the medicine is given *before* you are exposed to COVID-19 to try and prevent you from getting sick in the first place.

How long will I be in the study if I join?

The study will involve follow-up for a period of time, which the study team will explain in detail, likely many months, to fully assess the effectiveness and safety of the treatments.