AzTrials
AzTrials

Post-Acute COVID-19 SyndromePhase 3REVERSE-LCNCT05858515

REVERSE-Long COVID-19 With Baricitinib Study

A Phase 3 study testing Baricitinib 4 MG in people with Post-Acute COVID-19 Syndrome, run by Vanderbilt University Medical Center at 6 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-Acute COVID-19 Syndrome
What is being tested?
Baricitinib 4 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
6 sitesUnited States
Study dates
21 Oct 2024to 30 Dec 2029
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 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
  • 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
Show all 22Show fewer
  • Pregnancy or breastfeeding
  • Any history of venous thromboembolism ever
  • History of malignancy or lymphoproliferative disorder
  • Renal dysfunction with estimated glomerular filtration rate of < 30 mL/min/1.73m2
  • 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).
  • Positive Hepatitis B surface antibody, antigen or core antibody, or Positive Hepatitis C RNR or antigen
  • Positive HIV 4th generation (antibody/antigen) ELISA test
  • 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 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
  • History of chronic alcohol abuse, Intravenous (IV) drug abuse, or other illicit drug abuse within the 2 years prior to study entry
  • Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
  • Treatment with another investigational drug or other intervention < 30 days of study enrollment
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Emory University

    Atlanta, Georgia, 30329

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8300

  • Yale University

    New Haven, Connecticut, 06520

  • University of California San Francisco

    San Francisco, California, 30329

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed 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.

Being tested
Baricitinib 4 MG, Placebo
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baricitinib 4 MGDrug

    Also called Olumiant

    Nonproprietary name: Baricitinib

  • PlaceboDrug

    Placebo

Study groups in NCT05858515
Study groupRoleWhat they receive
PlaceboPlacebo comparatorThese participants will receive placebo for 24 weeks (6 mo)
Receives: Drug: Placebo
Intervention #1ExperimentalThese participants will receive baricitinib 4 mg daily for 24 weeks
Receives: Drug: Baricitinib 4 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment

    2 participants per month, on average, are randomized

    Measured: 6 months

  2. Diversity in enrollment

    40% of participants will be from individuals disproportionally affected by COVID (Black, Hispanic, Asian, American Indian)

    Measured: 6 months

  3. Study drug prescribed

    80% of participants received every prescribed dose of the study drug

    Measured: 9 months

  4. Study withdrawals

    Less than 20% participants will be deemed lost to follow up

    Measured: 18 months

  5. Adverse event reporting

    100% of Serious Adverse Events reported to Data Safety Monitoring Board within 24 hours of study team awareness

    Measured: 18 months

  6. Study dosing

    100% adherence to study drug dose adjustments guidelines

    Measured: 9 months

  7. Study completion

    80% of participants adhere to all study procedures and requirements

    Measured: 18 months

Secondary outcomes (12)

  1. Severe and Serious Adverse Events

    Compare the percentage of severe and serious adverse events between study arms from baseline to week 12.

    Measured: 9 months

  2. Premature study discontinuation

    Compare the rate of study drug/placebo premature discontinuation by study arm (tolerability)

    Measured: 9 months

  3. Global Neuropsychological Function

    Assess percentage changes of global neuropsychological function as measured using the CNS Vital Signs Neurocognition Index cognitive battery between baricitinib and placebo study arm from baseline to week 12.

    Measured: 9 months

  4. Cardiopulmonary testing

    Assess percentage changes of exercise capacity (peak VO2) using cardiopulmonary exercise testing (CPET) in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  5. Everyday Cognition

    Assess percentage changes of cognitive impairment using Everyday Cognition (ECog) scale in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  6. Functional Status

    Assess percentage changes of functional status measures in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  7. Quality of Life Measures

    Assess percentage changes of quality of life measures in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  8. Post-Exertional Malaise

    Assess percentage changes of post-exertional malaise using De Paul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM) in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  9. Shortness of Breath

    Assess percentage changes of the effect of breathlessness on daily activities using the Modified Medical Research Council Dyspnea Scale (mMRC) in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  10. Symptom Burden

    Assess percentage changes of post COVID-19 symptom burden using the Symptom Burden Questionnaire for Long COVID (SBQ-LC) Circulation Subscale in the baricitinib arm compared to the placebo arm from baseline to week 12

    Measured: 9 months

  11. Inflammation biomarkers

    Decreases in plasma biomarkers of inflammation in the baricitinib arm compared to placebo arm from baseline to week 12

    Measured: 9 months

  12. Viral Reservoirs

    Decreases in viral reservoirs for the baricitinib arm compared to placebo arm from baseline to week 12

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2023
  2. Study start21 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, placebo-controlled, double-blind, parallel-design superiority design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05858515
Sponsor's protocol ID
U13800
Acronym
REVERSE-LC
Status last verified
Jan 2026
First submitted
28 Mar 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib 4 MG in people with Post-Acute COVID-19 Syndrome, run by Vanderbilt University Medical Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05858515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in