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.
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:
- at birth to 17 years of age
- Having at least one symptom of COVID-19
- 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, Down syndrome)
- Infants (<1 year of age)
- Spinal cord injury
This study is enrolling different age groups within the age range from at birth to 17 years. There are other requirements for participation in the study. The study doctor will explain these to you including which age groups are currently enrolling.
Condition
COVID-19
Age
at birth -17 years
Sex
Male or Female
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
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 or powder. 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)
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.
Frequently asked questions
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.
Your participation in this study is completely optional. You can choose to stop participating in the study at any time, for any reason.
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.
