Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06631287

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Led by Wes Ely · Updated on 2026-05-11

550

Participants Needed

17

Research Sites

140 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

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.

CONDITIONS

Official 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...

  • Participant has personally signed informed consent and is willing and able to participate.
  • Age 18 years or older.
  • Documented SARS-CoV-2 infection at least 6 months before screening with acceptable proof.
  • Clinical evidence of Long COVID with at least one new or worsened symptom since infection, not explained by other causes.
  • Symptoms include systemic, neurocognitive, cardiopulmonary, musculoskeletal, or gastrointestinal symptoms.
  • Symptoms have been present for at least 6 months prior to screening and impact quality of life or daily functioning.
  • Cognitive impairment indicated by at least 20% positive responses on a specific cognitive questionnaire.
  • For Cohort #2: Clinical diagnosis of COVID between January 2020 and September 1, 2021 with defined symptom criteria.
  • Presence of Long COVID symptoms as described above for Cohort #2.
Not Eligible

You will not qualify if you...

  • Long COVID symptoms explained by a chronic condition diagnosed before COVID-19 (e.g., ME/CFS).
  • Pre-existing cognitive impairment not worsened by COVID-19.
  • Severe disability preventing study participation.
  • Moderate or high suicidality risk.
  • Major cardiovascular event within 3 months before enrollment.
  • Current use of baricitinib or other DMARDs (except certain minimal immunomodulatory drugs).
  • Known allergy to baricitinib components.
  • Participation in another baricitinib study within 30 days.
  • Positive COVID test within 14 days before screening.
  • Recent venous thromboembolism or high thrombosis risk.
  • Recent or unmanaged malignancy.
  • Previous ICU admission for acute COVID-19.
  • Significant kidney, liver, blood, or cholesterol abnormalities.
  • Positive hepatitis B or C (active infection).
  • Recent or complicated herpes zoster or herpes simplex infection.
  • Untreated or active tuberculosis.
  • Recent sepsis or significant infection.
  • Certain HIV-related criteria.
  • Immunocompromised status with unacceptable risk.
  • Recent investigational drug or device treatment.
  • Inability to follow up or comply with study procedures.
  • Persons of childbearing potential unwilling or unable to use contraception or abstain from sex.
  • Currently pregnant, breastfeeding, or unwilling to stop breastfeeding.
  • Currently incarcerated.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

W

Wes Ely, M.D.

CONTACT

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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