In this study, researchers are testing the investigational medicine MK-4482, also known as molnupiravir, in adults who have COVID-19 and who are at high risk for severe illness. This trial is being done to see if the investigational medicine is safe and effective, and if it may help prevent symptoms of COVID-19 from lasting a long time or coming back after the original infection.
What is the investigational medicine?
If you take part in this study, you will get the investigational medicine or a placebo. You have an equal chance (like tossing a coin) of getting the investigational medicine or the placebo. Both are tablets taken 2 times a day for 5 days.
A placebo looks like the study medicine, but it has no active ingredients. Researchers use a placebo to help them better understand the effects of the study medicine.
The investigational medicine, molnupiravir, has been approved in some countries to treat adults with COVID-19, but it may not be approved in your country.
CLINICALTRIALS.GOV IDENTIFIER
NCT06667700
EU CT Number
2023-507227-36
When you talk with your doctor or clinical trial team member, please have the trial identifier number available.
You may be able to take part in this study if you are 18 years or older and:
Have a health condition that may make you more likely to become very sick from COVID-19
Are not in the hospital for any reason
There are additional requirements that determine if you may qualify to be in this study, which the study doctor will discuss with you. You do not need to currently have COVID-19 to consider taking part in this study.
If you qualify and decide to participate:
You may get the investigational medicine and all study-related medical tests at no cost
Your overall health will be closely monitored by a study doctor
You may be reimbursed for study-related travel expenses
You may help researchers learn more about COVID-19 and the investigational medicine
Participation in the research study is voluntary, and you are free to leave it at any time. Your privacy will be maintained throughout the study.
You may be in this study for about 6 months if you currently have COVID-19 symptoms and have a positive COVID-19 test.
You may also be able to take part if you do not currently have symptoms of COVID-19. In this case, researchers will ask you to watch yourself for symptoms of COVID-19 until you have COVID-19. This may mean you are in the study for longer than 6 months.
If you take part in the study, you will visit the study clinic about 7 times. You will also have about 3 virtual visits (video or phone) with the study team.
Key study facts
Study Duration
Length of study: Active participation lasts approximately 6 months after onset of COVID-19 symptoms and positive COVID-19 test.
Study design: Approximately 3082 eligible participants will be randomized in a 1:1 ratio to receive either the investigational medicine or a placebo. A placebo looks like the investigational medicine but contains no active medicine.
You have an equal chance (like tossing a coin) of getting the investigational medicine or the placebo. Both are in the form of tablets taken 2 times a day for 5 days.
Trial start and end dates
Trial start date
December 2, 2024
Estimated primary completion date
January 26, 2031
Estimated trial completion date
January 26, 2031
This study has up to 5 periods:
Optional screening
This will happen if you don’t have COVID-19 symptoms. This can last up to several years from your first visit until you have symptoms of COVID-19 and a positive test for COVID-19. The study team will remind you to test for COVID-19 if you have symptoms.
Symptomatic screening
This will happen after symptoms start and you have a positive COVID-19 test. You will have medical tests in at least 1 visit during a time period of about 48 hours to see if you can take part in this study.
Intervention
You will visit the study clinic 3 times over 5 days. You will also take the investigational medicine or placebo during this period.
Primary follow-up
You will visit the study clinic 3 times over 28 days.
Extended follow-up
You will have 3 virtual visits over about 4 months. During these visits, the study doctor or a member of the study team will talk with you about how you are doing.
Study tests
During the study, you will:
Have certain medical tests, such as:
A physical exam
Blood tests
Your vital signs recorded (your heart rate, temperature, and oxygen level)
Pregnancy tests (if you can get pregnant)
Answer questions about your symptoms and how they affect your life and activities
Track your symptoms and when you take the study tablets in an electronic diary
There may be additional tests which the study staff can discuss with the participant.
COVID-19 is a disease caused by a virus. Symptoms can feel like a cold, the flu, or pneumonia. Most people who get COVID-19 recover easily, but some can get very sick. Having certain health conditions may make it more likely that you will have serious symptoms or side effects from COVID-19.
Some of these health conditions include:
Health conditions or medicines that lower your immune system
Organ transplant
Bone marrow transplant
Cancer
Diabetes
Lung disease such as asthma or COPD
HIV
Heart conditions such as heart failure or a prior heart attack
Kidney disease or dialysis
Liver disease such as cirrhosis
Prior stroke or other neurologic (brain or nerve) conditions
Also, as people get older and starting at about 50 years old, the chance of becoming very sick from COVID-19 gets higher. People who become very sick with COVID-19 may:
Need to go to the hospital
Be in the intensive care unit (ICU) of the hospital
Need a ventilator (breathing machine) to help them breathe
Even lose their lives
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest study site. Talk with a study site member for more information.
Frequently Asked Questions
About the MOVe-NOW Study
The MOVe-NOW Study is evaluating the safety of an investigational medicine in adults who are high risk for severe illness, and if the investigational medicine may help prevent symptoms of COVID-19 from lasting a long time or coming back after the original infection.
Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo is a material that looks like the investigational medicine but does not contain any active medication. Researchers use a placebo to help them better understand the effects of the study medicine.
You have an equal chance (like tossing a coin) of getting the investigational medicine or the placebo. Both are tablets taken 2 times a day for 5 days.
Privacy, Withdrawing, Costs, and Permission
The study team respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the study site at least once to complete a final visit and return any unused study medicine.
No, you will receive the study medicine at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your health.
About Research Studies
A research study, also known as a research trial, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational study medicine is safe and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the United States this group is called an IRB or Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational medicine is a medicine that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational medicine must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.
In this study, researchers are testing the investigational drug MK-4482, also known as molnupiravir, in adults who have COVID-19 and who are at high risk for severe illness. This trial is being done to see if the investigational drug is safe and effective, and if it may help prevent symptoms of COVID-19 from lasting a long time or coming back after the original infection.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
