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 most children who get COVID-19 will only have mild symptoms, those with certain medical conditions or other risk factors are more likely to develop severe illness and complications including hospitalization and MIS-C (a rare but serious inflammatory condition). PAXLOVID™ (nirmatrelvir/ritonavir) is authorized for the treatment of mild-to-moderate COVID-19 in people 12 years or older who weigh at least 88 pounds and are at risk for progression to severe illness. However, it is not currently available for children under the age of 12. The study aims to find the best dose for treating COVID-19 in children and to learn about the study drug’s safety and effectiveness in treating children with 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:
- less than 1 month to 17 years of age
- Having at least one symptom of COVID-19
- Meet weight requirements
- Having at least 1 of the following characteristics or underlying medical conditions:
- Overweight or obese
- Immunosuppressive disease (e.g. cancer treatment, HIV, autoimmune disorders)
- Chronic lung, heart, or kidney disease
- Hypertension (high blood pressure)
- Type 1 or Type 2 diabetes
- Current smoker
- 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 less than 1 month 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
less than 1 month - 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. 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.
