What side effects are associated with this type of intervention?

Baricitinib, a JAK inhibitor used to reduce inflammation and modulate the immune response, has several known side effects. Common adverse effects include headache, increased blood levels of creatine phosphokinase, decreased neutrophil count, and nasopharyngitis. Other potential side effects are mild infections and gastrointestinal symptoms. It is important for patients to discuss these risks with their healthcare provider to ensure the benefits outweigh the potential harms.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Post-COVID Syndrome (Long COVID). However, Baricitinib, a Janus kinase (JAK) inhibitor, has been studied for its potential benefits in reducing inflammation and modulating the immune response in conditions like Long COVID. Baricitinib is already FDA-approved for the treatment of moderate to severe rheumatoid arthritis and has been granted Emergency Use Authorization (EUA) for the treatment of COVID-19 in certain hospitalized patients. Ongoing trials are investigating its efficacy in treating Post-COVID Syndrome.

What other types of research exist?

Promising alternatives to Baricitinib for Post-COVID Syndrome patients include other JAK inhibitors such as Filgotinib, which has shown efficacy in inflammatory conditions like psoriatic arthritis. Additionally, monoclonal antibodies targeting specific inflammatory pathways, such as those used in MERS-CoV treatment, may also be considered. Clinical trials and further research will be essential to confirm their efficacy and safety in Post-COVID Syndrome.

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Janus Kinase (JAK) Inhibitor

Baricitinib for Long COVID (REVERSE-LC Trial)

Q: What is the mechanism of action of this treatment?

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baricitinib 4 MG

2023

Completed Phase 2

~10

0 / 13Eligibility criteria met

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.