A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
This study is looking for better ways to prevent serious illness from COVID-19, especially for people who are at higher risk. While most people get mild symptoms, some are more likely to become very sick and might need hospital care. This can include those with certain health conditions. The study medicine, Molnupiravir, is designed to stop the COVID-19 virus from making copies of itself in the body. Researchers want to see if Molnupiravir can prevent severe COVID-19 illness more effectively than a placebo (a dummy drug) in these high-risk individuals. It's also for people who can't use other existing COVID-19 treatments due to other health issues or medications they are taking.
At a glance
What is this study about?
Coronavirus Disease (COVID-19) is a virus that can cause symptoms similar to a cold or flu for most people. However, some individuals are more likely to get very ill from COVID-19. This higher risk can be due to existing health conditions or other factors, and in severe cases, it might lead to a hospital stay or even be life-threatening.
We are looking for new ways to protect these high-risk individuals and prevent serious illness. Sometimes, people who are at high risk can't take certain COVID-19 treatments. This could be because the treatments aren't available to them, or because they take other medicines that might react badly with the COVID-19 treatment, causing unwanted side effects.
Molnupiravir is the medicine being studied here. It's designed to stop the COVID-19 virus from multiplying inside your body. The main goal of this study is to find out if Molnupiravir is better than a dummy pill (placebo) at preventing severe COVID-19 illness in people who are at high risk. By finding new and safe treatments, we hope to reduce the number of people who get very sick from COVID-19.
Key takeaways
- This study is testing a new medicine, Molnupiravir, for COVID-19.
- It aims to prevent severe illness in people at high risk.
- Participants will receive either Molnupiravir or a dummy pill (placebo).
- It's for people who recently had a positive COVID-19 test and symptoms.
- You must be unable to take other common COVID-19 treatments.
- Participation involves taking the study medicine and regular check-ups.
Who may be eligible?
To join this study, you need to be at least 18 years old.
You must have recently tested positive for SARS-CoV-2 (the virus that causes COVID-19) within the last four days, and started having COVID-19 symptoms within the last four days. You also need to be experiencing at least two specific COVID-19 symptoms on the day you might join, such as a cough, sore throat, fever, or body aches.
Crucially, you must be considered at a high risk of getting seriously ill from COVID-19. This could mean you are 75 years or older, have a weakened immune system, or have other conditions like long-term lung disease, severe obesity, or diabetes. Another important factor is that you must not be able to take certain other common COVID-19 treatments, perhaps due to interactions with other medicines you are taking, or other health reasons.
- Are you 18 years old or older?
- Have you tested positive for COVID-19 in the last four days?
- Did your COVID-19 symptoms start within the last four days?
- Do you have at least two key COVID-19 symptoms right now (e.g., cough, fever, body aches)?
- Are you considered at high risk for serious COVID-19 illness (e.g., age 75+, weakened immune system, certain chronic conditions)?
- Are you unable to take other standard COVID-19 treatments due to medication interactions or other health reasons?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive either the study medicine, Molnupiravir, or a placebo (a dummy pill that looks the same but contains no medicine). You wouldn't know which one you are getting. You would need to take the medicine as directed and attend regular check-ups with the study team. These check-ups will involve things like symptom assessments, blood tests, and possibly other tests to monitor your health and how you're responding to the treatment. The study team will explain the full schedule, including how long you'll be involved and how many visits you'll need to make.
Potential risks and benefits
Locations (224)
- Cullman Clinical Trials ( Site 3813)Cullman, United States· Completed
- Helios Clinical Research ( Site 3826)Paradise Valley, United States· Recruiting
- Absolute Clinical Research ( Site 3709)Phoenix, United States· Recruiting
- Clinica de Salud del Valle de Salinas ( Site 3825)Castroville, United States· Recruiting
- Ascada Health PC dba Ascada Research ( Site 3750)Fullerton, United States· Completed
- Pacific Clinical Studies ( Site 3827)Los Alamitos, United States· Recruiting
- Valley Clinical Trials, Inc. ( Site 3707)Northridge, United States· Recruiting
- FOMAT Medical Research ( Site 3720)Oxnard, United States· Recruiting
- Paradigm Clinical Research, LLC ( Site 3785)San Diego, United States· Recruiting
- Optimus Medical ( Site 3817)San Francisco, United States· Recruiting
- Millennium Clinical Trials ( Site 3758)Westlake Village, United States· Recruiting
- Paradigm Clinical Research Centers, Inc ( Site 3718)Wheat Ridge, United States· Recruiting
+212 more sites — see the official record for the full list.
Common questions
What is Molnupiravir?
Molnupiravir is a study medicine designed to stop the COVID-19 virus from making copies of itself in your body, potentially reducing how sick you get.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.
How long will I be in the study?
The study team will tell you the exact duration, including how long you'll take the medicine and how many follow-up visits you'll have.
Will I know if I'm getting the real medicine or the placebo?
No, both you and the study team won't know whether you're receiving Molnupiravir or the placebo until after the study is complete, to keep the results fair.
What if my COVID-19 symptoms get worse?
The study team will monitor you closely. If your symptoms worsen or you have any concerns, you should contact them immediately. Your safety is their priority.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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