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Janus Kinase (JAK) Inhibitor

Baricitinib for Pediatric COVID-19 (COV-BARRIER Trial)

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requires supplemental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment
Hospitalized with coronavirus (SARS-CoV-2) infection
Must not have
History of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) or considered high risk of VTE (DVT/PE)
Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <40 milliliter/minute/1.73 meters squared
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4, day 7, day 10, day 14, and day 28
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if the drug baricitinib can help treat children in the hospital with COVID-19 and what the right dose is.

Who is the study for?
This trial is for hospitalized children aged 1 to <18 with COVID-19 who need supplemental oxygen but are not on invasive ventilation or ECMO. They should have confirmed respiratory disease from COVID-19 and be stable enough not to require hospital transfer within 72 hours. Children with severe liver issues, poor kidney function, known drug allergies, high risk of blood clots, certain infections or immunosuppression conditions are excluded.
What is being tested?
The study tests the effectiveness and safety of Baricitinib in pediatric patients hospitalized with COVID-19. It aims to confirm the appropriate dosage for treating these young patients effectively without causing harm.
What are the potential side effects?
While specific side effects for this age group aren't listed here, Baricitinib may generally cause immune system suppression leading to increased infection risk, liver enzyme elevations indicating potential liver injury, allergic reactions, and possibly blood clotting issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need extra oxygen and have lung issues from COVID-19 confirmed by a recent scan.
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I am hospitalized with COVID-19.
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I am under 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had blood clots in my veins or am at high risk for them.
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My kidney function is low, with an eGFR below 40.
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I have active TB or untreated latent TB.
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I am not currently on treatments that weaken my immune system.
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I need a machine to help me breathe at the time of joining the study.
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I am taking medication like probenecid that I cannot stop.
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I have an active cancer that may be risky with new treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4, day 7, day 10, day 14, and day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4, day 7, day 10, day 14, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK: Maximum Concentration (Cmax) of Baricitinib
Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
Secondary study objectives
All-Cause Mortality
Duration of Hospitalization
Duration of Stay in the Intensive Care Unit (ICU) in Days
+6 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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BaricitinibExperimental Treatment1 Intervention
Baricitinib given orally to participants daily
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?

Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,959 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,354 Total Patients Enrolled
~0 spots leftby Dec 2024
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