BridgeMD
New treatment option for Long COVID
Official title Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID
ClinicalTrials.gov ID: NCT06631287
What this study is testing
What is Baricitinib?
Baricitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for long covid.
Also referred to as OLUMIANT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- 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...
You likely can't join 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...
- Pre-existing cognitive impairment not exacerbated by COVID-19, including but not limited to syphilis, as determined by study clinicians (MD, DO, NP...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- Known prior allergic reactions to components of the baricitinib.
- Previously assigned by chance 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...
- Positive for Hepatitis C at the time of Screening. Note: treated or cleared Hepatitis C is not exclusionary.
- 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...
- 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...
- History of current or recent (\< 30 days from screening) sepsis or clinically significant viral, bacterial, fungal, or parasitic infection, according to the determination of the investigator.
- Participants with HIV will be excluded if they have been on ART \ 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...
- Immunocompromised 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.
- Treatment with another investigational drug or device as part of an treatment study within 30 days of study screening.
- 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.
- Persons of childbearing potential under age 55 who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening though at least 28 days after the end...
- Currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study.
- Participants actively breastfeeding, who are unwilling to stop breastfeeding for the duration of the trial.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Brooklyn, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Gainesville, Florida, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.