Do you or your child have symptomatic COVID-19? A clinical trial may be an option.
The FDA has granted Emergency Use Authorization for a 5-day course of PAXLOVID™ (nirmatrelvir/ritonavir) to treat COVID-19 in people at least 12 years of age with mild-to-moderate COVID-19 who are at risk of developing severe illness. However, people with weakened immune systems or other risk factors are more likely to have prolonged or treatment-resistant COVID-19.
This study is evaluating if a longer course of PAXLOVID™ may be beneficial for adults and adolescents with symptomatic COVID-19 who are immunocompromised.
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 people who:
- Are 12 years of age or older and weigh at least 40 kg (88 lbs.)
- Have been recently diagnosed with COVID-19 and currently have at least one symptom of COVID-19
- Are able to swallow tablets
- Are immunocompromised
Note: There are other requirements to participate in this study. A study team member will help determine if this study is right for you or your child.
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 you or your child is interested in participating, the study team will schedule a screening visit to determine if you/he/she can join the study.
You or your child will be randomly assigned to receive the study drug PAXLOVID™ for 5, 10, or 15 days:
- Group 1: 5 days PAXLOVID, 10 days placebo (no active ingredient)
- Group 2: 10 days PAXLOVID, 5 days placebo (no active ingredient)
- Group 3: 15 days PAXLOVID, 0 days placebo (no active ingredient)
All participants will take PAXLOVID™, and placebo (in case they are enrolled in groups 1 or 2), by mouth twice daily for 15 or 16 days, for a total of 30 doses.
You or your child will be enrolled in the study for about 6 months and will need to attend at least 10 study visits during this time. These visits will be completed in clinic. If in-clinic visits are not feasible, alternate locations may be allowed.
3-month and 6-month follow-up visits
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
PAXLOVID™ is a combination of the medicines nirmatrelvir and ritonavir. PAXLOVID™ was studied in a previous clinical trial of non-hospitalized adults with symptomatic COVID-19 who had at least 1 risk factor for progressing to severe COVID-19. The results from that study showed that participants who received PAXLOVID™ were less likely to be hospitalized or die from COVID-19 compared to participants who received a placebo.
PAXLOVID™ has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID™ is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
Frequently asked questions
How often will I have to attend study appointments?
You will need to attend at least 10 study visits over approximately 6 months. 8 of these visits will occur in the first 6 or 7 weeks. You will also have 2 long-term follow-up appointments at 3 months and 6 months.
What if I change my mind about participating?
Your participation in this study is completely optional. You can choose to leave the study at any time, for any reason.
What are the possible side effects? What if I have a negative reaction to the study treatment?
All clinical trials and treatments come with some risks. 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.
Does it cost anything to participate?
No, the study treatment and study-related procedures will be provided at no cost to you. Additionally, you may be eligible for reimbursement for your time and study-related expenses (like travel). Please ask your study team for more information.