NCT05858515WithdrawnPhase 3
REVERSE-Long COVID-19 With Baricitinib Study
REVERSE-Long COVID: A Multicenter Randomized, Placebo-Controlled Clinical Trial of Immunomodulation (With Baricitinib) for Long COVID Related Cognitive Impairment and ADRD (Alzheimer's Disease and Related Dementias)
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Reason given: This submission for the pilot study has been withdrawn as the full trial opened under a different NCT number before participants enrolled in the pilot.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 28 Mar 2023
- Start date
- 21 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Long COVID and ME/CFS, Alzheimer disease
- NCT number
- NCT05858515
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have had symptomatic herpes zoster infection within 3 months prior to study entry or have a history of disseminated/complicated herpes zoster or herpes simplex infection
- History of chronic alcohol abuse, Intravenous (IV) drug abuse, or other illicit drug abuse within the 2 years prior to study entry
- Treatment with another investigational drug or other intervention < 30 days of study enrollment
Other illness
- Pre-existing cognitive impairment not exacerbated by acute COVID as determined by study physicians after thorough review of participant's history and medical records
- Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs)
- Known allergic reactions to components of the baricitinib
- Any history of venous thromboembolism ever
- History of malignancy or lymphoproliferative disorder
- Positive Hepatitis B surface antibody, antigen or core antibody, or Positive Hepatitis C RNR or antigen
- Positive HIV 4th generation (antibody/antigen) ELISA test
- History of latent (diagnosed with Quantiferon testing) or active tuberculosis
- History of a current or recent (< 30 days from screening) clinically significant viral, bacterial, fungal, or parasitic infection
Lab values
- Absolute Neutrophil Count (ANC) <1200 cells/mm3
- History or evidence of severe or end-stage liver disease (e.g. bilirubin ≥1.5x or AST/ALT >2x normal).
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Have ever been randomized in this study or any other study investigating baricitinib
- Positive SARS-CoV-2 PCR or rapid Antigen test in the past 14 days
- Pregnancy or breastfeeding
- Renal dysfunction with estimated glomerular filtration rate of < 30 mL/min/1.73m2
- Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
- Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures
- Severe cognitive, physical, or psychological disability that would prevent participation in the study
Criteria the registry did not label
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Obtain a signed and dated informed consent form from participant
- State their willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 years old
- Meet the following criteria for "Post-COVID Condition" or Long COVID:
- 6-months prior, documented SARS-CoV-2 infection
- Cognitive impairment as defined by having at least 20% positive (worse or much worse) items on the ECOG assessment
- Neurocognitive symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening.
- Ability to take oral medication and be willing to adhere to the baricitinib regimen
- Females of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception from the time of screening though at least 28 days after the end of the study intervention period. Note: Acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University | Atlanta | United States | Unknown status |
| University of Minnesota | Minneapolis | United States | Unknown status |
| Vanderbilt University | Nashville | United States | Unknown status |
| Vanderbilt University Medical Center | Nashville | United States | Unknown status |
| Yale University | New Haven | United States | Unknown status |
| University of California San Francisco | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.