Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19

This important study is looking for better ways to treat COVID-19, especially for people who might be more likely to get seriously ill. Researchers are testing a new medicine called Bemnifosbuvir. They want to see if this medicine can stop people from needing to go to hospital or sadly, dying from COVID-19. They are comparing it to a common COVID-19 treatment called Paxlovid and a dummy treatment (placebo) to understand how well Bemnifosbuvir works and if it's safe. The study is particularly interested in people who already have conditions that put them at a higher risk if they catch COVID-19.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Atea Pharmaceuticals Inc., Atea Pharmaceuticals Inc.

Enrolment target

354

Start

18 Jul 2023

COVID-19

What is this study about?

This study is a research project designed to find out if a new medicine can help people who have COVID-19. It focuses on individuals who might be more likely to get very sick from the virus. The main goal is to see if this new medicine, called Bemnifosbuvir, can prevent them from needing to go into hospital or from becoming so unwell that they could die from COVID-19. They are also comparing it with another well-known COVID-19 treatment, Paxlovid, and a placebo (a dummy pill with no medicine) to make sure they get clear results.

The researchers will be carefully looking at several things. They want to know how many people get so ill they need hospital care or die. They'll also check for other problems caused by COVID-19, like severe breathing issues or heart problems. They are also interested in how often people feel better only to get sick again, or if the virus starts multiplying in their body again.

Studying new medicines in this way helps us understand if they are safe and truly effective. If a medicine is proven to work well, it could become a new treatment option to help people recover from COVID-19 and avoid serious health problems in the future. This type of research is a crucial step in finding better ways to manage the virus.

Key takeaways

This study is testing a new COVID-19 medicine, Bemnifosbuvir.
It's for people at higher risk of severe COVID-19.
The study compares Bemnifosbuvir with Paxlovid and a placebo.
The main aim is to prevent hospital stays and serious illness.
You would be monitored for up to 60 days to check your health and side effects.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women can take part. The study is specifically for people who are considered to be at a higher risk of getting seriously unwell with COVID-19.

Further details about what makes someone 'high-risk' would be discussed with you by the study team. This usually refers to people who have certain health conditions or other factors that increase their chances of severe COVID-19, but this study is not for children or teenagers younger than 18.

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 currently have COVID-19?
Have you been told you are at higher risk of severe COVID-19 due to other health factors?
Are you able to attend appointments or communicate with the study team for about 60 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the new medicine (Bemnifosbuvir), an existing medicine (Paxlovid), or a placebo (a pill that looks the same but contains no active medicine). You wouldn't know which one you were taking, and neither would the study doctors, to keep the results fair. You would take these medicines for a set period.

Throughout the study, you would have regular check-ups and assessments to monitor your health. This would include seeing how your COVID-19 symptoms are progressing, if you need any hospital care, and to check for any side effects from the medicine. These check-ups might involve appointments at a clinic or even phone calls or telemedicine visits. The study team will follow your health closely for about 60 days.

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 you recover from COVID-19 more quickly or prevent severe illness, or you might receive an existing effective treatment like Paxlovid. However, there's always a chance the medicine might not work for you, or you might receive the placebo. All medicines can have side effects, and the study team will carefully monitor you for any such effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Latvia
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Unverified
Netherlands
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Unverified
Sweden
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Unverified
Spain
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Unverified
Germany
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Unverified
Romania

Common questions

What is Bemnifosbuvir?

Bemnifosbuvir is a new medicine being tested to see if it can help people with COVID-19, especially those at higher risk of getting very sick.

What does 'high-risk' mean in this study?

'High-risk' refers to people who might have other health conditions or factors that make them more likely to become seriously unwell if they catch COVID-19. The study team can give you more details.

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

No, neither you nor the doctors will know. This is called 'double-blind' and helps ensure the study results are as fair and accurate as possible.

How long will I be involved in the study?

You would be followed for about 60 days from when you start the study, to see how your health progresses.

What if I feel unwell during the study?

The study team will be monitoring your health closely. If you feel unwell or have any concerns, you should contact them immediately for advice and care.