ClinicalTrials.gg
RecruitingNCT06631287REVERSE-LCUpdated Sep 25, 2026

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

A Phase 3 interventional study of Baricitinib and Placebo in Long COVID, Sars-CoV-2 Infection and Coronavirus Infections, sponsored by Wes Ely. Recruiting at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Wes Ely · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Since the emergence of the severe acute respiratory syndrome coronavirus 2 pathogen in late 2019, there have been over 680 million cases worldwide and over 6 million deaths. In the United States alone, there have been over 100 million cases and over 1 million deaths. Both novel vaccines and effective therapeutics have helped reduce mortality in well-resourced countries. Despite these advances, millions of patients subsequently experience a devastating post-acute infection syndrome known as post-acute sequelae of SARS-CoV-2 infection (PASC), or better known by patients as Long COVID (LC). In the United States alone, it is estimated that up to 18 million adults suffer from LC with persistent neurocognitive impairments (NCI) and cardiopulmonary symptoms such as dyspnea and exercise intolerance for months to years after acute COVID-19. Additionally, up to 1 in 5 patients who were working prior to contracting SARS-CoV-2 may not return to the workforce due to cognitive and physical impairments. The public health burden of LC is estimated to be the largest seen from an emerging disease in the last 100 years, yet there are currently no effective interventions.

These clear and objective changes in cognitive function and brain structure highlight the devastating and long-lasting effects of SARS-CoV-2 infection on survivors' long-term health, highlighting the need for effective therapies to improve long-term cognitive outcomes.

In addition to the devastating NCI that patients with LC experience, many survivors go on to experience activity-limiting dyspnea on exertion, exercise intolerance, and reduced physical function. In fact, patients who have not fully recovered physically 5 months after infection may fail to recover further by one year. Patients with LC experience significant self-reported physical symptoms including persistent fatigue and dyspnea as well as objective impairments in exercise capacity and physical function upon performance testing. These impairments, in addition to cognitive function and mental health, lead to significant reductions in quality of life for these survivors.

While viral reservoirs, systemic and organ-level inflammation are leading hypotheses for the mechanistic underpinnings of LC, no trials to date have investigated the use of agents targeting these mechanisms. Similar chronic inflammation plays a crucial role in the increased risk of cardiovascular disease (CVD) and NCI for people with HIV (PWH) as indicated by elevated soluble and cellular markers of inflammation, endothelial dysfunction, and hypercoagulability in this population. Activation of the Janus kinase (JAK)-STAT pathway, which drives a proinflammatory milieu, has been reported during HIV infection and is associated with CVD, NCI, and HIV persistence. Even in the absence of a viral infection, these same conditions and comorbidities are driven by a very similar chronic inflammatory state.

02

Conditions studied

  • Long COVID
  • Sars-CoV-2 Infection
  • Coronavirus Infections
  • COVID-19

Keywords

  • COVID-19
  • Long COVID Drug Treatment
  • Long COVID
03

In context

Post-Acute COVID-19 Syndrome

604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

This study's planned enrollment of 550 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

This is the only study on the registry with Wes Ely as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Cohort #1 (n=500):

  1. Evidence of personally signed and dated document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation.
  2. Age ≥18 years old.
  3. Documented SARS-CoV-2 infection 6 or more months prior to screening, confirmed with acceptable documentation that includes (at minimum) their name, the date the test was taken (must be after January 2020), and details specifying that the positive test was for SARS-CoV-2 infection.
  4. Clinical evidence of Long COVID, as confirmed by the investigator's assessment:

    a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent).

    i. Systemic symptoms (e.g., fatigue, chills, post-exertional malaise), neurocognitive symptoms (e.g., trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (e.g., chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (e.g., muscle aches, joint pain), gastrointestinal symptoms (e.g., nausea, diarrhea). Although other symptoms (e.g., skin rash, hair loss, mental health symptoms, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least one core symptoms listed above must be present.

    b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening.

    c. Symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome.

    d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire.

Cohort #2 (n=50):

  1. Evidence of personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation.
  2. Age ≥18 years old.
  3. Clinical diagnosis of COVID infection between January 2020 and September 1, 2021 (i.e., before home tests were widely available).

    a. Clinical Criteria (Based on Council of State and Territorial Epidemiologists Standardized Surveillance Case Definition for COVID-19): i. At least two of the following symptoms: Fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s).

    -OR- ii. At least one of the following symptoms: Cough, shortness of breath, or difficulty breathing.

    -OR- iii. Severe respiratory illness with at least one of the following: clinical or radiographic evidence of pneumonia or Acute Respiratory Distress Syndrome (ARDS).

    -AND- iv. No alternate more likely diagnosis

  4. Clinical evidence of Long COVID, as confirmed by the clinician's assessment:

    a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent).

    i. Systemic symptoms (e.g., fatigue, chills, post-exertional malaise), neurocognitive symptoms (e.g., trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (e.g., chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (e.g., muscle aches, joint pain), gastrointestinal symptoms (e.g., nausea, diarrhea). Although other symptoms (e.g., skin rash, hair loss, mental health symptoms, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least one core symptoms listed above must be present.

    b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening.

    c. Symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome.

    d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire.

Exclusion criteria

EXCLUSION CRITERIA:

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

  1. Qualifying Long COVID symptoms cannot be explained by an infection-associated chronic condition diagnosed prior to the onset of Long COVID (e.g., ME/CFS or other infection-associated chronic condition).
  2. Pre-existing cognitive impairment not exacerbated by COVID-19, including but not limited to syphilis, as determined by study clinicians (MD, DO, NP, PA, RN, or equivalent), which may include a review of participant's history and medical records.
  3. Severe cognitive, physical, or psychological disability preventing participation in the study, as determined by the investigator.
  4. Moderate or High risk of suicidality, as determined by the modified Columbia Suicide Severity Rating Scale (mC-SSRS).
  5. History of a major adverse cardiovascular event (MACE) within the 3 months prior to enrollment.
  6. Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs); however, DMARDs with minimal immunomodulatory effects (hydroxychloroquine, i.e., Plaquenil, used for less than 2 weeks, minocycline), are not exclusionary.
  7. Known prior allergic reactions to components of the baricitinib.
  8. Previously randomized in this study or in the last 30 days have been in another study investigating baricitinib.
  9. Positive SARS-CoV-2 NAAT or rapid Antigen test in the 14 days prior to screening.
  10. Venous thromboembolism in the past 6 months prior to screening or felt to be at increased risk of thrombosis by the investigator.
  11. or lymphoproliferative disorder not in remission for at least 5 years. Local non-melanoma skin cancers that are definitively managed are not exclusionary.
  12. Previous admission to an ICU for treatment of acute COVID-19 infection.
  13. Estimated of \< 30 mL/min/1.73m2, as calculated using the CKD-EPI 2021 equation.
  14. (ANC) \<1000 cells/mm3, confirmed on repeat testing.
  15. Absolute Leukocyte Count (ALC) \<100 cells/mm3.
  16. Evidence of severe liver disease at the time of screening, defined as > 1.5 X or or ALT > 2x ULN.
  17. Alkaline Phosphatase (ALP) ≥ 3x ULN.
  18. Creatine Phosphokinase (CPK) ≥ 3x ULN.
  19. (HgB) \< 8 g/dL, confirmed on repeat testing.
  20. \<100,000 cells/mm3, confirmed on repeat testing.
  21. Platelets >500,000 cells/mm3, confirmed on repeat testing.
  22. Total fasting cholesterol ≥ 280 mg/dL, confirmed on repeat testing.
  23. Fasting LDL ≥ 180 mg/dL, confirmed on repeat testing.
  24. Positive surface antigen or Hepatitis B core antibody. Note: Individuals with a positive Hepatitis B core antibody will be excluded even in the presence of a positive Hepatitis B surface antibody due to the risk of reactivation.
  25. Positive for at the time of Screening. Note: treated or cleared Hepatitis C is not exclusionary.
  26. Symptomatic herpes zoster infection (i.e., visible herpetic skin lesions of Zoster) within 3 months prior to study screening, or any history of disseminated/complicated herpes zoster or herpes simplex infection (e.g., VZV encephalitis).
  27. History of untreated latent tuberculosis infection (diagnosed with QuantiFERON-TB Gold Plus testing) or active tuberculosis whether treated or untreated. Note: those with a positive PPD who have a history of BCG vaccine and a negative QuantiFERON-TB Gold Plus test will remain eligible).
  28. History of current or recent (\< 30 days from screening) sepsis or viral, bacterial, fungal, or parasitic infection, according to the determination of the investigator.
  29. Participants with will be excluded if they have been on ART \<1 year, have a \<500 cells/ml (confirmed on repeat), or have two consecutive HIV plasma RNA viral load > 48 copies/mL within 1 year of study screening, including requiring the most recent within 3 months of screening. Blips (VL > 48 copies/mL but \< 200 copies/mL) are permitted if preceded and followed by values below the assay limit of quantification.
  30. as defined by NIH COVID-19 guidelines (see Appendix) and, in the opinion of the investigator, at an unacceptable risk for participating in the study.
  31. Treatment with another drug or device as part of an interventional study within 30 days of study screening.
  32. In the opinion of the investigator, unable to reliably follow-up for the duration of the study and/or are unable to follow study restrictions/procedures.
  33. Persons of under age 55 who are unwilling or unable to abstain from sex or to use at least one acceptable method of 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), other contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about risks related to pregnancy or breastfeeding.
  34. Currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study.
  35. Participants actively breastfeeding, who are unwilling to stop breastfeeding for the duration of the trial.
  36. Currently incarcerated

NOTE RE: History of major adverse cardiovascular event (MACE) or traditional risk factors including smoking. For REVERSE-LC, MACE is defined as acute myocardial infarction and stroke. The study team will discuss the risks and benefits of baricitinib and CV events with the participant prior to study entry.

NOTE RE: EBV/CMV Seropositivity - The investigators will not exclude participants based on EBV or CMV seropositivity. The investigators already know that serologic evidence suggesting recent EBV reactivation is associated with Long COVID fatigue and high level EBV responses are associated with neurocognitive Long COVID, but that EBV viremia and IgM is rare. The investigators believe there is equipoise with regard to the potential effects of baricitinib on EBV - it is as likely that inflammation drives EBV reactivation, just as EBV can drive inflammation. For this reason, the investigators think this is best studied as a biological factor correlated with outcomes and that the investigators should not deliberately include or exclude people based on this. CMV seropositivity is associated with improved Long COVID outcomes. Results are not required for screening.

Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
550 participants (estimated)

Study arms

  • Experimental
    Baricitinib

    Janus kinase inhibitor

    Drug: Baricitinib

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

  • 4mg encapsulated, pre-formed tablet PO once daily for 24 weeks.

    Also known as: OLUMIANT

  • OtherPlacebo

    Matched placebo capsule, PO once daily for 24 weeks.

06

What researchers measure

Primary outcomes

  1. CNS-Vital Signs Global Cognitive Index

    Objective neuropsychological function determined using the CNS-Vital Signs Global Cognitive Index between study arms at 6-months, adjusted for baseline. CNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.

    Time frame: Month 6

Secondary outcomes

  1. Objective neuropsychological function domains of executive function, memory, processing speed, and motor speed including the CNS-Vital Signs subscale tests at 6-months.

    CNS-Vital Signs Global Cognitive Index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.

    Time frame: Month 6

  2. Objective neuropsychological function domains of executive function, memory, processing speed, and motor speed including the CNS-Vital Signs subscale tests at 12-months.

    CNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.

    Time frame: Month 12

  3. Modified Everyday Cognition (mECog)

    Subjective participant-reported cognitive impairment including modified Everyday Cognition (mECog) scale at 3-, 6-, and 12-months. The mECog measure uses the sum score of all of the subscales, and the items are reverse coded (i.e., 1= "Better or no change", 2="Questionable/occasionally worse", 3="Consistently a little worse", 4="Consistently much worse"), meaning that lower scores are better. Reported total scores range from 39 (Better or no change) to 156 (Consistently much worse).

    Time frame: Months 3, 6 and 12

  4. Exercise capacity including the 6-minute walk test (6MWT) at 6- and 12-months

    Total distance in meters walked in 6 minutes

    Time frame: Months 6 and 12

  5. Cardiopulmonary exercise testing (CPET)

    Cardiorespiratory fitness (peak VO2) using cardiopulmonary exercise testing (CPET) at 6- and 12- months. CPET is used to assess change in exercise tolerance as measured by VO2max.

    Time frame: Months 6 and 12

  6. Quality-of-life measures including the EuroQOL-5D-5L at 3-, 6-, and 12-months

    The 5-Level EuroQol-5D health questionnaire (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The index value total (which is country-specific) ranges from a minimum value of -1 to a maximum value of +1. A higher EQ-5D-5L index value represents better quality of life (QoL), thus a positive change in the index value represents improved QoL.

    Time frame: Months 3, 6, and 12

  7. Post-exertional malaise including the modified De Paul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM) at 6- and 12-months

    The mDSQ-PEM has 10 questions (5 on severity and 5 on frequency) scored 0-4, with higher scores indicating greater post exertional malaise severity.

    Time frame: Months 6 and 12

  8. Effect of breathlessness on daily activities including the Modified Medical Research Council Dyspnea Scale (mMRC) at 6- and 12-months

    Modified Medical Research Council Dyspnea Scale (mMRC) ranges from grade 0 to 4. 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).

    Time frame: Months 6 and 12

  9. Post COVID-19 symptom burden including the Symptom Burden Questionnaire for Long COVID (SBQ-LC) Circulation Subscale at 1-, 3-, 6-, and 12-months

    The SBQ-LC Circulation Subscale consists of 5 questions with a score of 0-11 where higher scores indicate greater circulation-related symptom burden.

    Time frame: Months 1, 3, 6, and 12

  10. General participant-reported outcomes using the PROMIS-29 at 1-, 3-, 6-, and 12-months

    The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 has 29 questions across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) each scored 1-5, with higher scores indicating worse symptoms or better function, depending on the domain.

    Time frame: Months 1, 3, 6, and 12

  11. Cognitive participant-reported outcomes using the PROMIS-Cognitive Function-Short Form 8a at 1-, 3-, 6-, and 12-months

    The Patient-Reported Outcomes Measurement Information System-Cognitive Function-Short Form 8a (PROMIS-CF-8a) has 8 questions, each scored 1-5, with higher scores indicating better cognitive function.

    Time frame: Months 1, 3, 6, and 12

  12. Mental health measures including depression, anxiety, and stress using the DASS-21 at 6- and 12-months

    The Depression Anxiety Stress Scale (DASS)-21 is a set of three (depression, anxiety, stress) self reported scales. Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+. Anxiety Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+. Stress Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+.

    Time frame: Months 6 and 12

  13. Orthostatic intolerance using the Orthostatic Intolerance Questionnaire (OIQ) at 3-, 6-, and 12-months

    Each subscale is scored on a 0-10 scale, with higher scores reflecting more severe symptoms compared to few/no symptoms at lower scores. The OISA has a total possible score of 40 and the OIDAS a total possible score of 60.

    Time frame: Months 3, 6, and 12

  14. Autonomic dysfunction using the COMPASS-31 at 3-, 6-, and 12-months.

    The Composite Autonomic Symptom Score (COMPASS)-31 has 31 questions across six health domains (orthostatic Intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor), scored 0-4 with higher scores indicating greater autonomic symptom burden.

    Time frame: Months 3, 6, and 12

07

Study locations

17 of 17 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Illinois Research Network (ILLInet), University of Illinois Chicago · Chicago, United StatesContact a•••@uic.edu · •••9588→r•••@uic.edu · •••4577Contact •••1694→•••4577Contact j•••@uic.edu→r•••@uic.edu
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Illinois Research Network (ILLInet), University of Illinois Chicago · Chicago, United StatesContact a•••@uic.edu · •••9588→r•••@uic.edu · •••4577Contact •••1694→•••4577Contact j•••@uic.edu→r•••@uic.edu
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06631287
Lead sponsor
Wes Ely
Responsible party
Wes Ely (Professor, Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center) — Sponsor-investigator
First posted
Oct 8, 2024
Start date
Oct 21, 2024
Primary completion
Nov 1, 2026 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Amanda Bistran-Hall
Contact
vccrvlcstudy@vumc.org
615-343-8010
Wes Ely, M.D.
Contact
Wes Ely, M.D.
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Baricitinib

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