NCT05799495

If you have signs or symptoms of COVID-19, consider a clinical trial of an investigational oral medicine that could help shorten your illness so you can get back to what matters sooner.

While new medications have been effective in reducing the severity of COVID-19 in people at increased risk, these treatments are not available or convenient for everyone. Development of a COVID-19 treatment for those who are not hospitalized or considered high-risk could help more people recover faster.

This clinical trial is evaluating if an investigational oral medicine is safe, and if it can reduce the amount of COVID-19 virus in adults with symptomatic COVID-19 who may not be candidates for current treatments.

Card Summary Component

Who may participate

Joining a clinical trial is an important and personal decision. Thank you for your consideration.

This clinical trial may be an option if you:

  • Are 18-64 years old
  • Currently have at least one sign or symptom of COVID-19, and your symptoms started within the past five days
  • Will not receive locally available antiviral treatment for COVID-19 (i.e., remdesivir, PAXLOVID, molnupiravir)
  • Have not received a COVID-19 vaccine within the last two weeks
  • Are not currently hospitalized

There are other requirements for participation in the clinical trial. The study doctor will explain these to you.

Condition

COVID-19

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18-64 years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria.  However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

Participants will be randomly assigned to receive the study medicine at one of three dose levels, or placebo. The placebo looks like the study medicine but does not contain any active ingredient. Both the study medicine and placebo are tablets taken by mouth twice daily for five days (ten total doses). 

Participants will need to track their doses on a paper diary and COVID-19 signs/symptoms in an electronic diary (eDiary) app on their mobile device or a device provided by the study team.

Participants will be enrolled for about five weeks and will need to attend at least seven study visits during this time. Study visits will be a combination of in-person at the study site and via telehealth.  

The study medicine and all study-related procedures will be provided at no cost.

Length of study treatment

5 or 6 days (10 total doses)

Length of study treatment is the length of time the study participants will receive the study treatment.

 

Number of study visits

At least 7

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

4 weeks

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

About the study medicine

About the study medicine

The study medicine is taken as three oral tablets twice daily for five days (or six days if only one dose was taken on Day 1). Researchers believe it may help shorten recovery time, prevent hospitalization, and reduce the likelihood of progression to more severe illness or death by preventing the COVID-19 virus from replicating in the body.

The study medicine may provide a potential treatment option for non-hospitalized patients with COVID-19 who are at standard risk and others who may not be candidates for current treatment options.

It is considered investigational because it has not been approved or authorized for use outside of clinical trials.

About the study medicine

About clinical trials

Clinical trials allow researchers to compare investigational medicines with current approved treatments. They help us understand if the possible benefits of a potential treatment option outweigh the risks.

Every modern medicine we have today was first tested in clinical trials. Thousands of volunteers around the world take part in clinical trials every year.

Frequently asked questions

What should I do if I develop signs or symptoms of COVID-19?

If you are interested in participating in this clinical trial, it is important that you contact the study team as soon as possible. You must have developed signs or symptoms of COVID-19 within five days of entering the clinical trial.

Click here and answer a few questions to see if you pre-qualify and connect with a member of the study team. They will be able to arrange COVID-19 testing, determine if this study is a good fit for you, and answer any questions you may have.

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How long will I be in this study?

Participation in this clinical trial will last about five weeks.

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What are the possible benefits of participating?

This clinical trial may not provide any direct benefit to you. If you choose to participate, you may receive an investigational medicine that could shorten your illness or prevent your symptoms from worsening. Your health will be monitored regularly throughout. Additionally, you will be contributing to research that will help us learn more about a potential treatment for COVID-19 and may help others with COVID-19 in the future.

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What are the possible risks of participating?

All clinical trials have some risks. Your study doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll. You can choose to leave the clinical trial at any time.

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What if I change my mind about participating?

Your participation in this clinical trial is completely optional. You can choose to stop participating at any time, for any reason. Choosing not to participate in this clinical trial will not affect your future medical care in any way.

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What will happen at study visits?

What happens at each study visit will vary, but may include questions about your medical history, a physical exam, COVID-19 tests, ECGs, and blood draws.

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