NCT05487040
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
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.
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.
