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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Long COVID, Sars-CoV-2 Infection, Coronavirus Infections, COVID-19

In brief

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.

Key facts

Study ID

NCT06631287

Run by

Wes Ely

People needed

550

Starts

2024-10-21

Expected to finish

2027-07-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this investigation, an individual must meet all of the following criteria:
• Cohort #1 (n=500):
• 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.
• Age ≥18 years old.
• 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.
• 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):
• 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.
• Age ≥18 years old.
• 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
• 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.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this investigation:
• 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).
• 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.
• Severe cognitive, physical, or psychological disability preventing participation in the study, as determined by the investigator.
• Moderate or High risk of suicidality, as determined by the modified Columbia Suicide Severity Rating Scale (mC-SSRS).
• History of a major adverse cardiovascular event (MACE) within the 3 months prior to enrollment.
• Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs); however, DMARDs with minimal immunomodulatory effects (hydroxychloroquine, i.e., Plaquenil, steroids used for less than 2 weeks, minocycline), are not exclusionary.
• Known prior allergic reactions to components of the baricitinib.
• Previously randomized in this study or in the last 30 days have been in another study investigating baricitinib.
• Positive SARS-CoV-2 NAAT or rapid Antigen test in the 14 days prior to screening.
• Venous thromboembolism in the past 6 months prior to screening or felt to be at increased risk of thrombosis by the investigator.
• Malignancy or lymphoproliferative disorder not in remission for at least 5 years. Local non-melanoma skin cancers that are definitively managed are not exclusionary.
• Previous admission to an ICU for treatment of acute COVID-19 infection.
• Estimated glomerular filtration rate of < 30 mL/min/1.73m2, as calculated using the CKD-EPI 2021 equation.
• Absolute Neutrophil Count (ANC) <1000 cells/mm3, confirmed on repeat testing.
• Absolute Leukocyte Count (ALC) <100 cells/mm3.
• Evidence of severe liver disease at the time of screening, defined as Bilirubin > 1.5 X ULN or AST or ALT > 2x ULN.
• Alkaline Phosphatase (ALP) ≥ 3x ULN.
• Creatine Phosphokinase (CPK) ≥ 3x ULN.
• Hemoglobin (HgB) < 8 g/dL, confirmed on repeat testing.
• Platelets <100,000 cells/mm3, confirmed on repeat testing.
• Platelets >500,000 cells/mm3, confirmed on repeat testing.
• Total fasting cholesterol ≥ 280 mg/dL, confirmed on repeat testing.
• Fasting LDL ≥ 180 mg/dL, confirmed on repeat testing.
• Positive Hepatitis B 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States (enrolling)
• University of California, Los Angeles (UCLA) — Los Angeles, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• University of Colorado I Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of Florida College of Medicine — Gainesville, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Illinois Research Network (ILLInet), University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• NYU Langone Health - Brooklyn — Brooklyn, New York, United States (enrolling)
• University Hospitals Cleveland Case Western — Cleveland, Ohio, United States (enrolling)
• The MetroHealth System — Cleveland, Ohio, United States (enrolling)
• Vanderbilt University Medical — Nashville, Tennessee, United States (enrolling)
• University of Texas at San Antonio — San Antonio, Texas, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• West Virginia Clinical and Translational Science Institute — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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