NCT05261139

Does your child have COVID-19 signs or symptoms, or have they been recently diagnosed with COVID-19? A clinical trial may be an option.

While there is hope that the worst of the pandemic is behind us, hundreds of thousands of cases of COVID-19 are still reported daily around the globe. That is why it’s so important to continue to advance not only prevention, but also the treatment of COVID-19.

This potential oral treatment study is underway for children and teens recently diagnosed with COVID-19 or who have symptoms of COVID-19.

Card Summary Component

Who may participate

 

Joining a clinical trial is an important and personal decision. Thank you for considering this study.

This study may be an option for children and teens who are:

  • 6 to 17 years of age 
  • Having at least one symptom of COVID-19
  • Able to swallow tablets
  • Able to meet weight requirements
  • Having at least 1 of the following characteristics or underlying medical conditions: 
    • Overweight or obese
    • Current smoker
    • Immunosuppressive disease (i.e. cancer treatment, HIV, autoimmune disorders)
    • Chronic lung, heart, or kidney disease 
    • Hypertension (high blood pressure)
    • Type 1 or Type 2 diabetes 
    • Sickle cell disease 
    • Active cancer (not including skin cancer)
    • Neurodevelopmental disorder (i.e. cerebral palsy, Downs syndrome)

There are other requirements for participation in the study. 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

6-17 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.

Card Summary Component

What to expect

If the child or teen is interested in participating, the study team will schedule a screening visit to determine if he/she can join the study. 

The child or teen will receive the study medicine as oral tablets. The first dose will be given at the study site. Subsequent doses will be taken at home twice daily over the next 5 days, for a total of 10 doses. 

The child or teen will be enrolled in the study for about 5 weeks, and they will need to attend at least 8 study visits. These may include a combination of in-person visits at the clinic or your home, or remote visits over the telephone or computer.
 

Length of study treatment

5 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 8 study visits. These may include a combination of in-person visits at the clinic or your home, or remote visits over the telephone or computer.

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

Frequently asked questions

How often will I have to attend study appointments?

You will need to attend at least 8 study visits over approximately 5 weeks. These may include a combination of in-person visits at the clinic or your home, or remote visits over the telephone or computer.

Is this page helpful?
0
0

What if I change my mind about participating?

Your participation in this study is completely optional. You can choose to stop participating in the study at any time, for any reason.

Is this page helpful?
0
0

What are the possible side effects? What if I have a negative reaction to the study treatment?

Your study doctor will discuss all the possible risks and benefits of participating in this study with you before you choose to enroll. You can choose to no longer participate in the study at any time.

Is this page helpful?
0
0