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Janus Kinase (JAK) Inhibitor
Baricitinib for Long COVID (REVERSE-LC Trial)
Phase 3
Waitlist Available
Led By E. Wesley Ely, MD, MPH
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, aged ≥18 years old
Ability to take oral medication and be willing to adhere to the baricitinib regimen
Must not have
History of a current or recent (< 30 days from screening) clinically significant viral, bacterial, fungal, or parasitic infection
Severe cognitive, physical, or psychological disability that would prevent participation in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Pivotal Trial
Summary
This trial is testing baricitinib, a medication that reduces inflammation, in adults with long-term brain or heart and lung symptoms from COVID-19. The goal is to see if it can improve their symptoms by calming the immune system. Baricitinib was originally approved for rheumatoid arthritis and has been repurposed for COVID-19 treatment due to its anti-inflammatory and antiviral properties.
Who is the study for?
Adults over 18 who had COVID-19 at least 6 months ago, with ongoing neurocognitive or cardiopulmonary symptoms for 60+ days. Must be able to take oral meds and follow the study plan, including contraception if applicable. Excludes those currently infected, on certain drugs like DMARDs, with a history of serious infections or conditions like tuberculosis, HIV, cancer, severe liver disease; also excludes pregnant/breastfeeding individuals.
What is being tested?
The pilot study is testing Baricitinib (4 MG), an oral medication against placebo in adults suffering from long-term cognitive or heart/lung issues after COVID-19. It's part of a larger phase 3 trial focusing on Long COVID treatment effectiveness.
What are the potential side effects?
Baricitinib may cause side effects such as infection risks due to immune system changes, blood clots, liver enzyme elevations indicating potential liver injury, cholesterol increases which could affect heart health and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take pills and will follow the medication plan.
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I have cognitive issues affecting my daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a serious infection within the last 30 days.
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I do not have severe disabilities that would stop me from joining the study.
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I have had cancer or a related disease before.
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I am willing and able to follow the study's requirements.
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I have had a blood clot in my veins at some point.
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My kidney function is low, with a filtration rate under 30 mL/min.
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My liver is not severely damaged (bilirubin and AST/ALT levels are not too high).
Select...
I have had a severe or widespread herpes infection recently.
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I am currently taking baricitinib or other similar arthritis medications.
Select...
I have been diagnosed with tuberculosis before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse event reporting
Diversity in enrollment
Enrollment
+4 moreSecondary study objectives
Cardiopulmonary testing
Everyday Cognition
Functional Status
+9 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention #1Experimental Treatment1 Intervention
These participants will receive baricitinib 4 mg daily for 24 weeks
Group II: PlaceboPlacebo Group2 Interventions
These participants will receive placebo for 24 weeks (6 mo)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Janus kinase (JAK) inhibitors, like Baricitinib, are commonly used treatments for Post-COVID Syndrome. They work by blocking the activity of enzymes in the JAK family, which are key players in the signaling pathways that cause inflammation and immune responses.
By inhibiting these pathways, JAK inhibitors reduce inflammation and modulate the immune system. This is particularly important for Post-COVID Syndrome patients, who often experience prolonged inflammatory and immune responses, leading to symptoms such as fatigue, cognitive impairment, and respiratory issues.
Effective modulation of these responses can significantly improve their quality of life.
Find a Location
Who is running the clinical trial?
University of MinnesotaOTHER
1,420 Previous Clinical Trials
1,621,064 Total Patients Enrolled
University of California, San FranciscoOTHER
2,570 Previous Clinical Trials
15,174,990 Total Patients Enrolled
Yale UniversityOTHER
1,912 Previous Clinical Trials
3,039,001 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious infection within the last 30 days.I agree to use birth control or practice abstinence during and for 28 days after the study.I do not have severe disabilities that would stop me from joining the study.I have had symptoms affecting my thinking or memory for at least 60 days.I have had cancer or a related disease before.You tested positive for HIV using a 4th generation ELISA test.I am willing and able to follow all study procedures for its duration.You had a confirmed COVID-19 infection within the last 6 months.I am 18 years old or older.I am willing and able to follow the study's requirements.I have had a blood clot in my veins at some point.I can take pills and will follow the medication plan.My kidney function is low, with a filtration rate under 30 mL/min.My liver is not severely damaged (bilirubin and AST/ALT levels are not too high).I have had a severe or widespread herpes infection recently.You have been diagnosed with Hepatitis B or Hepatitis C.You tested positive for COVID-19 in the past 14 days.I am currently taking baricitinib or other similar arthritis medications.I have been diagnosed with tuberculosis before.You are allergic to any parts of the baricitinib medication.You have a memory or thinking problem that was not made worse by COVID-19, as decided by the study doctors after looking at your medical history and records.Your body has too few infection-fighting white blood cells.I have cognitive issues affecting my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention #1
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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