REVERSE-Long COVID-19 With Baricitinib Study

Last updated: January 29, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Trial Not Available

Phase

3

Condition

Covid-19

Treatment

Placebo

Baricitinib 4 MG

Clinical Study ID

NCT05858515
U13800
  • Ages > 18
  • All Genders

Study Summary

REVERSE-LC is a phase 3 trial of baricitinib versus placebo in adults with neurocognitive impairment (a form of Alzheimer's Disease and Related Dementias or ADRD) or cardiopulmonary symptoms due to Long COVID.

Eligibility Criteria

Inclusion

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Obtain a signed and dated informed consent form from participant

  2. State their willingness to comply with all study procedures and availability for theduration of the study

  3. Male or female, aged ≥18 years old

  4. Meet the following criteria for "Post-COVID Condition" or Long COVID:

  5. 6-months prior, documented SARS-CoV-2 infection

  6. Cognitive impairment as defined by having at least 20% positive (worse or muchworse) items on the ECOG assessment

  7. Neurocognitive symptoms must have been present for at least 60 days prior toscreening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening.

  8. Ability to take oral medication and be willing to adhere to the baricitinib regimen

  9. Females of childbearing potential must agree to either abstinence or use at leastone acceptable method of contraception from the time of screening though at least 28days after the end of the study intervention period. Note: Acceptable methodsinclude barrier contraceptives (condoms or diaphragm) with spermicide, intrauterinedevices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgicalsterilization.

Exclusion

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Pre-existing cognitive impairment not exacerbated by acute COVID as determined bystudy physicians after thorough review of participant's history and medical records

  2. Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs)

  3. Known allergic reactions to components of the baricitinib

  4. Have ever been randomized in this study or any other study investigating baricitinib

  5. Positive SARS-CoV-2 PCR or rapid Antigen test in the past 14 days

  6. Pregnancy or breastfeeding

  7. Any history of venous thromboembolism ever

  8. History of malignancy or lymphoproliferative disorder

  9. Renal dysfunction with estimated glomerular filtration rate of < 30 mL/min/1.73m2

  10. Absolute Neutrophil Count (ANC) <1200 cells/mm3

  11. History or evidence of severe or end-stage liver disease (e.g. bilirubin ≥1.5x orAST/ALT >2x normal).

  12. Positive Hepatitis B surface antibody, antigen or core antibody, or PositiveHepatitis C RNR or antigen

  13. Positive HIV 4th generation (antibody/antigen) ELISA test

  14. Have had symptomatic herpes zoster infection within 3 months prior to study entry orhave a history of disseminated/complicated herpes zoster or herpes simplex infection

  15. History of latent (diagnosed with Quantiferon testing) or active tuberculosis

  16. History of a current or recent (< 30 days from screening) clinically significantviral, bacterial, fungal, or parasitic infection

  17. History of chronic alcohol abuse, Intravenous (IV) drug abuse, or other illicit drugabuse within the 2 years prior to study entry

  18. Are immunocompromised and, in the opinion of the investigator, are at anunacceptable risk for participating in the study

  19. Treatment with another investigational drug or other intervention < 30 days of studyenrollment

  20. Are unable or unwilling to make themselves available for the duration of the studyand/or are unwilling to follow study restrictions/procedures

  21. Severe cognitive, physical, or psychological disability that would preventparticipation in the study

Study Design

Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 21, 2024
Estimated Completion Date:
December 30, 2029

Study Description

This is a multi-site randomized, placebo-controlled, double-blind, parallel-design REVERSE-LC phase 3 study. Individuals meeting inclusion criteria will be randomized to one of two arms: the intervention arm of baricitinib 4 mg daily for 24 weeks (dose adjusted to 2 mg or 1 mg for baseline renal dysfunction) versus the placebo arm for 24 weeks. In addition to safety, a variety of clinical and biological outcome measures will be assessed.

Connect with a study center

  • University of California San Francisco

    San Francisco, California 30329
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-8300
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.