Actively Recruiting
Randomized Double-Blind Placebo-Controlled Trial Evaluating Baricitinib for Persistent Neurologic and Cardiopulmonary Symptoms of Long COVID
Led by Wes Ely · Updated on 2026-05-11
550
Participants Needed
17
Research Sites
34 weeks
Total Duration
On this page
Sponsors
W
Wes Ely
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether baricitinib, compared to a placebo, can improve brain function, physical health, quality of life, and symptoms related to Long COVID. The study focuses on adults with persistent neurological and cardiopulmonary symptoms lasting at least six months after COVID-19 infection. It aims to understand how this medication affects inflammation, viral markers, and various aspects of health impacted by Long COVID, a condition affecting millions worldwide with ongoing cognitive and physical challenges. Participants will be randomly assigned to receive either baricitinib, a medication taken as a 4mg tablet once daily for 24 weeks, or a matching placebo capsule taken daily for the same duration. The trial includes careful monitoring through multiple assessments over a 12-month period. These assessments examine cognitive function, physical capacity, quality of life, breathlessness, symptom burden, mental health, and autonomic function at various intervals. The study uses a double-blind approach where neither participants nor researchers know who receives the medication or placebo. During the study, participants will undergo tests including cognitive evaluations, exercise tests like the 6-minute walk, questionnaires about symptoms and quality of life, and mental health assessments. Researchers will measure changes in global cognitive function at six months as the primary outcome, along with many secondary outcomes at different time points up to one year. Safety and symptom tracking will continue throughout the trial, which started in late 2024 and runs through mid-2027, allowing detailed observation of how baricitinib may affect Long COVID symptoms over time.
CONDITIONS
Brief Title
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent with understanding of the study
- Age 18 years or older
- Documented positive COVID-19 test at least 6 months before screening
- Clinical evidence of Long COVID with new or worsened symptoms lasting 6 months or more
- Symptoms impact quality of life or daily functioning
- Cognitive impairment defined by at least 20% positive responses on a cognitive questionnaire
You will not qualify if you...
- Long COVID symptoms explained by another chronic condition diagnosed before COVID-19
- Pre-existing cognitive impairment not worsened by COVID-19
- Severe disabilities preventing study participation
- Moderate or high risk of suicidality
- Major cardiovascular events within 3 months before enrollment
- Current use of baricitinib or certain immunomodulatory drugs
- Allergic reactions to baricitinib components
- Recent participation in other baricitinib studies
- Positive COVID-19 test within 14 days before screening
- Recent blood clots or high risk of thrombosis
- Certain blood or liver abnormalities and infections
- Pregnant or breastfeeding or unwilling to use contraception
- Currently incarcerated
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take either Baricitinib or a placebo once daily to assess treatment effects on persistent neurologic and cardiopulmonary symptoms of Long COVID.
Regular visits during the 24 weeks for medication dispensing and monitoring
Duration - Up to 6 months after treatment ends
Participants are monitored after treatment completion for cognitive function, physical symptoms, quality of life, mental health, and autonomic function.
Visits at 1, 3, 6, and 12 months with assessments including cognitive and physical tests and questionnaires
Trial Site Locations
Total: 17 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90024
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
University of Colorado I Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Illinois Research Network (ILLInet), University of Illinois Chicago
Chicago, Illinois, United States, 60608
Actively Recruiting
9
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
NYU Langone Health - Brooklyn
Brooklyn, New York, United States, 11220
Actively Recruiting
12
University Hospitals Cleveland Case Western
Cleveland, Ohio, United States, 44106
Actively Recruiting
13
The MetroHealth System
Cleveland, Ohio, United States, 44109
Actively Recruiting
14
Vanderbilt University Medical
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
University of Texas at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
16
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
17
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, United States, 26506-7015
Actively Recruiting
Research Team
A
Amanda Bistran-Hall
W
Wes Ely, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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