Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID (REVERSE-LC)
Wes Ely
Summary
The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.
Description
Since the emergence of the severe acute respiratory syndrome coronavirus 2 pathogen in late 2019, there have been over 680 million cases worldwide and over 6 million deaths. In the United States alone, there have been over 100 million cases and over 1 million deaths. Both novel vaccines and effective therapeutics have helped reduce mortality in well-resourced countries. Despite these advances, millions of patients subsequently experience a devastating post-acute infection syndrome known as post-acute sequelae of SARS-CoV-2 infection (PASC), or better known by patients as Long COVID (LC). In th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: In order to be eligible to participate in this investigation, an individual must meet all of the following criteria: Cohort #1 (n=500): 1. Evidence of personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation. 2. Age ≥18 years old. 3. Documented SARS-CoV-2 infection 6 or more months prior to screening, confirmed with acceptable documentation that includes (at minimum) their name, the date the test was taken (must be after January 2020),…
Interventions
- DrugBaricitinib
4mg encapsulated, pre-formed tablet PO once daily for 24 weeks.
- OtherPlacebo
Matched placebo capsule, PO once daily for 24 weeks.
Locations (16)
- University of ArizonaTucson, Arizona
- University of California, Los Angeles (UCLA)Los Angeles, California
- University of California San FranciscoSan Francisco, California
- University of Colorado I Anschutz Medical CampusAurora, Colorado
- Yale UniversityNew Haven, Connecticut
- University of Florida College of MedicineGainesville, Florida