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New Clinical Trial Will Test How Baricitinib Improves Neurocognitive Function in Patients with Long Covid

People with Long Covid may participate in an important new clinical trial—the REVERSE-LC trial (Evaluating Baricitinib on Persistent Neurologic and Cardiopulmonary Symptoms of Long COVID)—which will test whether the drug baricitinib improves neurocognitive function and other functions severely diminished by Long Covid. Dr. Wesley Ely, an internationally respected pulmonologist and critical care doctor at Vanderbilt University Medical Center, is leading this trial.

Baricitinib inhibits the Janus kinase protein. Because Janus kinase regulates the immune response and inflammation, baricitinib can strongly reduce autoimmunity and inflammation for some patients. In 2018, the FDA approved baricitinib for treating patients with rheumatoid arthritis; and in 2020, for treating patients with severe COVID. Baricitinib was the first immunomodulating drug approved for people with acute COVID (it may also function as an antiviral agent by inhibiting infection). Baricitinib helps people critically ill with COVID to survive, and the World Health Organization strongly recommends that these patients take this drug.

The overall goal of the REVERSE-LC trial will be to determine how much baricitinib improves neurocognitive function in people with Long Covid. The team will also measure how baricitinib affects other critical symptoms and functions—like ability to exercise, autonomic dysfunctions, burden of post-COVID symptoms, effects of breathlessness on daily activities, inflammation, mental health orthostatic intolerance, post-exertional malaise, quality of life, and viral burden. Participants will take either a baricitinib pill or a placebo pill once a day for six months, and the study team will check participants every month during on-site visits. During these visits, participants will give blood samples and take physical and neurological tests and may volunteer to give other more specialized samples and tests (like lumbar punctures and MRI scans). After patients finish the six-month treatment, the study team will continue to watch them for another six months; thus, people who sign up will be participating for a year.

Researchers at the University of Pennsylvania and Yale University will collaborate with Dr. Ely’s team at Vanderbilt for this work. The National Institutes of Health has great confidence and hope in Dr. Ely’s trial, scoring his application for the trial as excellent (in the top 4% of all applications considered).

This clinical trial is especially important for people with Long Covid because it is the first to evaluate a drug that targets chronic organ- and system-level inflammation, which may be a main cause of Long Covid symptoms. Hyperactive Janus kinase and the ensuing inflammation are related to poor neurocognition in patients with other diseases. By inhibiting the Janus kinase pathway, baricitinib may reduce chronic inflammation, thus improving neurocognitive functions, mental health, and quality of life. The study team estimates they will finish collecting neurocognition data by November 2026; and all other data, by July 2027.

The team is now recruiting 550 people from the continental US to participate. There are four enrolling centers—one in California (at the University of California, San Francisco), one in Minnesota (the University of Minnesota), one in Tennessee (Vanderbilt University), and one in Georgia (Emory University). Participants must be at least 18 years old; have results from either an antigen test or a nucleic acid amplification test showing infection by SARS-CoV-2 that happened at least six months ago; and have evidence of Long Covid. The clinical trial team asks that participants have had symptoms of Long Covid for at least six months because they want to focus on people whose symptoms didn’t spontaneously improve early on. (Indeed, if a person’s Long Covid symptoms persist after five months, they may continue for a year or more.) Importantly, the team is also welcoming people whose symptoms have persisted for up to three years; by including these people, the team may learn how much baricitinib improves long-standing symptoms.

Unlike other trials for which people may participate at home or online, for the REVERSE-LC trial participants must travel to the enrollment sites because researchers must perform rigorous, detailed tests. The team will financially compensate participants for their time and will pay for hotel accommodation during on-site visits.

For more information on enrolling in the REVERSE-LC trial, patients should contact Ms. Amy Bazzoni (615-343-8010, vccrvlcstudy@vumc.org). Patients may also find more information on the study website (https://www.reversinglongcovid.org/).

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