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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 below
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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:
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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).
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I have had a severe or widespread herpes infection recently.
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I am currently taking baricitinib or other similar arthritis medications.
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I have been diagnosed with tuberculosis before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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 more
Secondary study objectives
Cardiopulmonary testing
Everyday Cognition
Functional Status
+9 more

Awards & 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

Baricitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05858515 — Phase 3
Post-COVID Syndrome Research Study Groups: Intervention #1, Placebo
Post-COVID Syndrome Clinical Trial 2023: Baricitinib Highlights & Side Effects. Trial Name: NCT05858515 — Phase 3
Baricitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05858515 — Phase 3
~367 spots leftby Dec 2027