RecruitingPHASE3INTERVENTIONAL

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

This study is testing a new medicine called ibuzatrelvir. It's for adults and teenagers (aged 12 and over) who have COVID-19 but don't need hospital care yet. These individuals are chosen because they have certain health conditions or are of a certain age, making them more likely to develop severe COVID-19. Half of the participants will receive ibuzatrelvir, and the other half will receive a dummy medicine (placebo). The researchers want to find out if ibuzatrelvir can prevent people from getting seriously ill and if it's safe to use. The study medicine is taken by mouth for 5 days, and participants will be followed for about 6 months.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

2,330

Start

08 Dec 2024

Estimated completion

02 Mar 2028

COVID-19 SARS-CoV-2 Infection

What is this study about?

This study is investigating a new medicine called ibuzatrelvir. The main goal is to find out if this medicine can help adults and teenagers (from 12 years old) who have COVID-19. We're particularly focusing on people who are not currently sick enough to go to hospital, but who have other health issues or are of an age that means they could get much sicker from COVID-19.

At the moment, we want to learn if ibuzatrelvir can stop these patients from becoming severely ill, and if it's safe for them to take. Think of it like this: if you have COVID-19 and are at a higher risk of complications, could this medicine help prevent that? The study is a significant step in understanding potential new treatments for COVID-19, especially for those who need extra protection.

This type of study, called a Phase 3 trial, is a very important stage of testing a new medicine before it can be made widely available. It helps doctors and scientists understand how well the medicine works compared to not taking it, and to closely monitor for any side effects. Your participation would help us gather crucial information to potentially help many others in the future.

Key takeaways

It's a study for adults and teenagers with COVID-19.
It's looking at a new medicine called ibuzatrelvir to prevent severe illness.
Participants must have COVID-19 and certain risk factors but not need hospitalisation.
You'll take pills for 5 days and be followed for about 6 months.
You might get the real medicine or a dummy pill.

Who may be eligible?

To join this study, you need to be at least 12 years old. If you're between 12 and under 18, you also need to weigh at least 40 kg. All participants must have a confirmed COVID-19 infection, diagnosed recently, and started feeling symptoms within the last 5 days. You also need to be experiencing at least one COVID-19 symptom on the day you join the study.

Another important aspect is that you must have certain risk factors that make you more likely to get very ill from COVID-19, even if you're not in hospital right now. These risk factors vary depending on your age. For example, younger adults (12-49) need to have at least two risk factors, one of which must be a moderate weakness in their immune system. Older adults (75 and above) don't need specific risk factors to be eligible based on age alone. Examples of risk factors include being a current smoker, having certain long-term lung or heart conditions, diabetes, or obesity. You also need to be unable to take another specific COVID-19 medicine (nirmatrelvir/ritonavir).

However, you can't join if you currently need to go to hospital for severe COVID-19, or if doctors think you will within the next 24 hours. People with serious kidney or liver problems are also not able to take part in this 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 12 years old or older? (If 12 to 17, do you weigh at least 40 kg?)
Have you recently tested positive for COVID-19?
Did your COVID-19 symptoms start within the last 5 days, with at least one symptom still present today?
Do you have certain medical conditions or are you of an age that puts you at higher risk for severe COVID-19?
Are you currently NOT so sick that you need to be in hospital, or likely to be admitted in the next 24 hours?
Can you NOT take another COVID-19 medicine called nirmatrelvir/ritonavir?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be in it for about 6 months. When you first start, you'll be randomly chosen (like flipping a coin) to receive either the study medicine, ibuzatrelvir, or a dummy medicine (placebo). You won't know which one you're getting, and neither will your doctors.

Both ibuzatrelvir and the dummy medicine are pills you take by mouth every day for 5 days. During this time, you may also receive other standard COVID-19 treatments that are normally available where you live. Throughout the approximately 6 months, you'll have regular check-ups and assessments. These appointments will involve doctors asking about your symptoms, taking your temperature, blood pressure, and possibly blood or other samples. This is to monitor how you're feeling, if your COVID-19 symptoms are improving, and to check for any side effects or changes in your health. These visits help the researchers understand how safe and effective the medicine is.

Potential risks and benefits

By taking part, you might benefit from the study medicine if it proves to be effective in preventing severe COVID-19. However, there's also a chance you could receive the dummy medicine and not experience any direct benefit from the study treatment. All medicines carry potential risks, and there might be side effects from ibuzatrelvir, some of which we may not fully know about yet. The study team will closely monitor you for any problems. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (244)

Applied Research Center of Arkansas
Verified postcode
Little Rock, United States· Recruiting
National Institute of Clinical Research - Bakersfield
Verified postcode
Bakersfield, United States· Recruiting
Velocity Clinical Research, Huntington Park
Verified postcode
Huntington Park, United States· Recruiting
310 Clinical Research
Verified postcode
Inglewood, United States· Recruiting
Long Beach Research Institute
Verified postcode
Long Beach, United States· Recruiting
Long Beach Clinical Trials
Verified postcode
Long Beach, United States· Recruiting
Pacific Clinical Studies Inc.
Verified postcode
Los Alamitos, United States· Recruiting
Downtown L.A. Research Center, Inc.
Verified postcode
Los Angeles, United States· Recruiting
Clinica mi Salud by Focil Med
Verified postcode
Oxnard, United States· Recruiting
FOMAT Medical Research
Verified postcode
Oxnard, United States· Recruiting
Paradigm Clinical Research, LLC
Verified postcode
Redding, United States· Recruiting
Acclaim Clinical Research
Verified postcode
San Diego, United States· Recruiting

Common questions

What is the study medicine?

The study medicine is called ibuzatrelvir, which is being tested to see if it can help people with COVID-19 who are at higher risk of becoming very sick.

Who can join this study?

Adults and teenagers (12 years and older) with COVID-19 who are not in hospital but have certain risk factors for severe illness may be able to join.

How long will I be in the study?

The total time you'd be involved in the study is around 6 months, starting from when you begin taking the medicine.

Will I know if I'm getting the real medicine?

No, you won't know if you're getting ibuzatrelvir or a dummy pill (placebo). This helps us get fair and accurate results.

What happens if I change my mind?

You can decide to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

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