New Haven, Conn. — Yale School of Medicine announces the initiation of a novel, randomized trial that will test whether receiving PAXLOVIDTM (nirmatrelvir tablets; ritonavir tablets) for 15 days can improve the health of highly symptomatic adults with Long COVID.
The trial, led by Yale School of Medicine Professors Harlan Krumholz and Akiko Iwasaki, has a decentralized design, meaning that participants do not have to travel to study sites. It also uses a novel, participant-centric, digital approach to data collection.
Long COVID, also known as post-acute sequelae SARS-CoV-2 infection (PASC), is estimated to affect millions of people worldwide. For some people, Long COVID has severely impaired their quality of life and even caused death. To date, there are no approved treatments for Long COVID.
The new trial will enroll 100 research participants and investigate the overall effect of PAXLOVID, while also seeking clues for which people might respond best to the drug and why. Importantly, the study will assess changes in how people feel and how their immune system functions in response to the drug. The study will enroll previously healthy people with fair to poor health as a result of Long COVID. Participants will not have any contraindications to PAXLOVID or recent treatment with the drug.
The decentralized design seeks to make participation easier and avoid the need for travel to a study site. The study uses mobile devices for study surveys, the Hugo Health digital health platform to engage participants and connect clinical data, and a strategy to collect biospecimens at a convenient place for participants. The study will be initially open to people in Connecticut, New York, and Florida.
The Yale Center for Infection and Immunity and the Yale Center for Outcomes Research and Evaluation at Yale School of Medicine are collaborating on the study. Pfizer is funding the study and has provided scientific support in the clinical trial design and protocol development. For more information, see the listing on clinicaltrials.gov (NCT05668091).
The research study is enrolling through the Hugo Health Kindred Long COVID community, which is an open and growing community for people interested in research into Long COVID. The community is oriented toward a partnership model of research and data sharing.
Dr. Krumholz is a co-founder of Hugo Health.
For any questions about the study, contact YalePaxStudy@yale.edu.