The Yale Paxlovid for Long COVID (PAX LC) Trial
Thank you for being interested in the Yale Paxlovid for Long COVID (PAX LC) Trial!
This research study will test whether 15 days of the study drug Paxlovid, compared with placebo, can improve the health of people living with Long COVID.
One possible cause of Long COVID is persistence of the SARS-CoV-2 virus long after the initial infection. Paxlovid is an anti-viral medication that is authorized by the Food and Drug Administration (FDA) for 5-day treatment of acute COVID infection. This research study will also be collecting blood and saliva samples to understand how our body’s immune system responds to Long COVID.
For this research study, Long Covid is defined as prior infection with SARS-CoV-2, followed by the onset of symptoms within 4 weeks of the initial infection that persist for at least 3 months. The research study uses online study surveys, the Hugo Health digital health platform to engage participants and connect clinical data, and the collection of blood and saliva samples at a convenient place for participants. This type of research study, designed to make participation easy, is called “decentralized”: participants do not need to go to research sites and can be part of the study from home.
The study is co-led by Professors Harlan Krumholz and Akiko Iwasaki. They are committed to working in partnership with the participants and other researchers to generate new knowledge rapidly. People living with Long COVID contributed to the protocol (how the study is conducted). A person living with Long COVID is on the oversight committee for the research study. Everyone who participates in the research study will have opportunities to interact with the investigators and to be among the first to learn of the results.
You May Be Eligible to Participate in This Research Study If You:
- Have been previously infected by SARS-CoV-2
- Have symptoms consistent with Long COVID that began within 4 weeks of the infection and continued for more than 12 weeks
- Were healthy before you developed Long COVID
- Are not participating in another interventional research study
- Can access an internet-capable computer or mobile device to access a digital health system
- Do not have renal or liver dysfunction, HIV, acute SARS-CoV-2, any other medical condition requiring hospitalization and/or surgery within 7 days of study entry
- Have regular medical care and had a health visit within the last 6 months
- Are not pregnant or breastfeeding
- Have connected your health information to Hugo Health and filled out the screening survey
- Are 18 years of age or older
- Reside in Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
- Are willing and able to provide informed consent
- Are comfortable reading and writing in English
How the Study Works
How to Join the Study
The Yale Center for Infection and Immunity (CII), the Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE) and the Yale Center for Clinical Investigation (YCCI) are working together to support this study. Pfizer provided funding for the study and also participated in the design development.
The Yale PAX LC Principal Investigator is Harlan Krumholz, MD, SM. As a disclosure, Dr. Krumholz is a co-founder of Hugo Health. As a developer of the Hugo Health platform, Dr. Krumholz is not receiving financial benefit now but may in the future.
A description of the PAX LC trial can be found at: https://clinicaltrials.gov/ct2/show/NCT05668091.
If you have further questions, please email us at YalePaxStudy@yale.edu.