Learn more about a research opportunity for adults with chronic kidney disease recently diagnosed with symptomatic mild-to-moderate COVID-19.
This clinical trial will measure blood levels of study medicine, PF-07321332 (nirmatrelvir/ritonavir; brand name PAXLOVIDTM) in adults with chronic kidney disease (either requiring or not requiring hemodialysis treatment) who have developed signs and symptoms of COVID-19 and who have been diagnosed with COVID-19 in the last 5 days. All participants in this study will receive PAXLOVID once daily for 5 days.
Who may participate
Joining a clinical trial is an important decision for you and your family. Your doctor may have mentioned this study to you, or perhaps you found your way here by yourself. Either way, thank you for your interest.
This study may be an option for people who:
- Are at least 18 years old
- Have developed symptoms of COVID-19 and been diagnosed with COVID-19 within the last 5 days (Positive COVID-19 test can be confirmed at your first study visit)
- Have been diagnosed with chronic kidney disease (renal impairment) and either do or do not require hemodialysis treatment
- Are able to swallow tablets and capsules
Note: There are other requirements to participate in this study. A study team member will help determine if this study is right for you.
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 are interested in participating, the PAXLOVIDTM, study team will schedule a Screening Visit to determine if this study is a good fit for you.
All participants will take the study drug PAXLOVID by mouth once daily for 5 days. Participants will need to track their doses using an electronic diary application (eDiary app). Participants, caregivers, or a home health nurse will also need to collect blood samples at home for several days during this study.
Participants will be enrolled in the study for about 34 days and will need to attend at least 6 study visits during this time. These will be a combination of in-person at the clinic, or in your home, or over the phone.
About the study medicine, PAXLOVID
The FDA has authorized the emergency use of PAXLOVIDTM, an investigational medicine, for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.
PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.
Frequently asked questions
How long will I be enrolled in this study?
About 34 days.
How often will I need to attend study visits?
You will need to attend at least 6 study visits over about 34 days. Your first visit will be in-person at the study site. Your remaining visits will be a combination of in-person at the study site or at your home, or over the phone.
What if I change my mind about participating?
Your participation in this study is completely optional (your choice). You can choose to leave the study at any time, for any reason.
What are possible side effects?
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.