Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06631287

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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