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Janus Kinase (JAK) Inhibitor

Baricitinib for Post-COVID Syndrome (REVERSE-LC Trial)

Phase 3
Recruiting
Led By Wes Ely, M.D.
Research Sponsored by Wes Ely
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical evidence of Long COVID as confirmed by the clinician's assessment
Age ≥18 years old
Must not have
Previous admission to an ICU for treatment of acute COVID-19 infection
History of current or recent sepsis or clinically significant infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, and 12
Awards & highlights
Pivotal Trial

Summary

"This trial aims to see if baricitinib can help improve brain function, physical abilities, quality of life, and other symptoms in people with Long COVID when compared to a placebo."

Who is the study for?
This trial is for individuals experiencing long-term symptoms after COVID-19, often referred to as Long COVID. Participants should have persistent neurological or cardiopulmonary issues like brain fog, fatigue, or shortness of breath. Specific eligibility criteria are not provided but typically include age limits and health status requirements.
What is being tested?
The study aims to see if Baricitinib can improve brain function and quality of life in people with Long COVID compared to a placebo (a substance with no therapeutic effect). It's a randomized trial where participants unknowingly receive either the real drug or placebo.
What are the potential side effects?
While specific side effects for this trial aren't listed, Baricitinib may commonly cause infections, blood clots, liver enzyme elevations, cholesterol increases, and allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor has confirmed I have Long COVID.
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I am 18 years old or older.
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I have been diagnosed with Long COVID by a doctor.
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My symptoms began after January 2020 and have lasted for at least 6 months.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was in the ICU for COVID-19 treatment.
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I have had a serious infection or sepsis recently.
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My HIV status does not meet certain criteria.
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I do not have severe disabilities that prevent me from joining the study.
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My cancer or lymph disorder has not been in remission for 5 years.
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I am currently taking medication for rheumatoid arthritis.
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I am currently taking probenecid.
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I am under 55, can have children, and won't use birth control or abstain from sex.
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I have never been treated for latent or active tuberculosis.
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I can follow the study's schedule and rules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CNS-Vital Signs Global Cognitive Index
Secondary study objectives
Autonomic dysfunction using the COMPASS-31 at 3-, 6-, and 12-months.
Cardiopulmonary exercise testing (CPET)
Cognitive participant-reported outcomes using the PROMIS-Cognitive Function-Short Form 8a at 1-, 3-, 6-, and 12-months
+11 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
6%
Nasopharyngitis
3%
Upper respiratory tract infection
3%
Bronchitis
2%
Influenza
2%
Back pain
2%
Urinary tract infection
1%
Pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BaricitinibTreatment B
Placebo Follow-up
Baricitinib Follow-up
Adalimumab Treatment B
Placebo Treatment B
Adalimumab Follow-up
Baricitinib Treatment A
Adalimumab Treatment A
Placebo Treatment A
Rescue

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: BaricitinibExperimental Treatment1 Intervention
Janus kinase inhibitor
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510

Find a Location

Who is running the clinical trial?

Wes ElyLead Sponsor
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,209 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,187,782 Total Patients Enrolled
~367 spots leftby Nov 2026
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