Ongoing, recruitingTherapeutic use (Phase IV)Interventional

European Randomised Clinical Trial on mPOX Infection (EPOXI)

The EPOXI study is a research project for adults with monkeypox. It's designed to see how well a medication called tecovirimat works compared to a dummy capsule (placebo) that looks identical. Both types of capsules are given to participants. The main goal is to find out how quickly skin rashes and lesions heal completely after starting treatment. This healing means the skin is new and fresh. The study will also look at how quickly other symptoms improve and if the virus disappears. This research is important for improving future treatments for monkeypox and helping patients recover faster.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

University Medical Center Utrecht

Enrolment target

335

Start

19 Dec 2022

Monkeypox

What is this study about?

This research study, called EPOXI, is for people in Europe who have monkeypox. Doctors are trying to find the best ways to treat this infection. In this study, they are looking at a medicine called tecovirimat in capsule form. Some people will get the active medicine, while others will get a 'dummy' capsule (a placebo) that looks exactly the same but doesn't contain the medicine. This is a common way to test new treatments fairly.

The main thing the doctors want to find out is how long it takes for all the skin lesions (rashes) to fully heal, meaning new, healthy skin has grown. They will check this around 28 days after someone starts treatment. They're also interested in how quickly other symptoms like tiredness, fever, or pain get better, and if the monkeypox virus disappears from the body. They will be checking people regularly to see how they are getting on.

This study is a 'Phase 4' clinical trial. This means the medicine, tecovirimat, is already approved for some uses, but doctors want to learn more about how it works specifically for monkeypox in a real-world setting. The information from this study will help healthcare professionals understand more about monkeypox, improve treatment guidelines, and help people recover better in the future.

Key takeaways

The EPOXI study is a research trial for adults with monkeypox.
It compares an anti-monkeypox medicine (tecovirimat) with a dummy capsule.
The main goal is to see how quickly skin rashes and other symptoms heal.
Participation involves regular clinic visits for physical exams and symptom checks.
The study lasts for up to 90 days, with monitoring for healing and side effects.
This research aims to improve future treatment for monkeypox patients.

Who may be eligible?

This study is looking for adult patients, 18 years and older, who have monkeypox. Both men and women can take part in this research.

If you have been diagnosed with monkeypox, your doctor might talk to you about this study. They will check if your overall health and your specific monkeypox symptoms mean you are a good fit for the study.

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?
Have you been diagnosed with monkeypox?
Are you able to attend regular clinic visits for up to 3 months?
Are you willing to take capsules as instructed by the study team?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either the active tecovirimat capsules or dummy capsules that look the same. You'll take these capsules as instructed. Your study doctor will see you regularly for check-ups over several weeks, likely at days 7, 14, and 28. During these visits, the doctor will examine your skin lesions and ask about your symptoms, like tiredness, pain, or fever. You might also have a swab taken from a lesion to check for the virus. Some visits might be longer than others. There will also be follow-up checks at 60 and 90 days. The total time you'd be involved in the study would be up to 90 days (about 3 months).

Potential risks and benefits

Taking part in this study could potentially help your monkeypox symptoms improve. However, it's also possible you could receive the dummy capsules, meaning you wouldn't get the active medicine. There might be side effects from the medication, though these will be carefully monitored. The study also involves several hospital visits and tests. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

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

—
Unverified
Netherlands
—
Unverified
France
—
Unverified
Portugal
—
Unverified
Germany
—
Unverified
Belgium
—
Unverified
Spain
—
Unverified
Norway
—
Unverified
Italy

Common questions

What is tecovirimat?

Tecovirimat is a medicine in capsule form that doctors are studying to see how well it helps people with monkeypox.

What is a 'dummy capsule'?

A dummy capsule (placebo) looks exactly like the medicine capsule but doesn't contain the active drug. It helps compare the real medicine's effects.

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

No, neither you nor your study doctor will know whether you are receiving the active medicine or the dummy capsule. This is to ensure fair and accurate results.

How long will I be in the study?

You will be in the study for about 90 days (around 3 months) from when you start taking the capsules, with regular check-ups during this time.

What happens after the study ends?

After your last study visit, your regular doctor will take over your care as usual. The information from the study will help improve treatments for future patients.