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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4, day 7, day 10, day 14, and day 28
Awards & highlights

COV-BARRIER 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.Check my eligibility
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.See study design
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.

COV-BARRIER Trial Eligibility Criteria

Inclusion Criteria

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

COV-BARRIER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Maximum Concentration (Cmax) of Baricitinib
Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
Secondary outcome measures
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
10%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Treatment A
Adalimumab Treatment B
Placebo Treatment B
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Follow-up
BaricitinibTreatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue

COV-BARRIER 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
2,618 Previous Clinical Trials
3,201,536 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,730 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does this trial hope to achieve for participating patients?

"The primary objective of this clinical trial, which will be measured over a Day 1 and Day 4 time span, is to assess the Maximum Concentration (Cmax) of Baricitinib. Furthermore, this trial will also be evaluating secondary outcomes includingOverall improvement on the NIAID-OS, Percentage of Participants Who Require Noninvasive Ventilation/high-flow oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO]), and Percentage of Participants with at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS"

Answered by AI

What are the known dangers of Baricitinib?

"There is some data to support the efficacy of Baricitinib, and multiple rounds of data support its safety, so our team at Power has given it a safety rating of 3."

Answered by AI

What are the prerequisites for subjects in this research?

"Eligible patients for this coronavirus clinical trial must have contracted the disease and be between 2 and 18 years of age. There is space for approximately 24 patients."

Answered by AI

What other research projects have there been on Baricitinib?

"Currently, there are 34 active clinical trials testing Baricitinib. Of these, 17 are in Phase 3. Although several trials for Baricitinib are based in Pune, Maharashtra, there are 1,438 total locations for these studies."

Answered by AI

Could you tell me how many hospitals in Canada are participating in this clinical trial?

"There are 9 recruiting patients for this study at locations such as University of Virginia Health System in Charlottesville, The University of Mississippi Medical Center in Jackson, and Children's Hospital of Michigan in Detroit,as well as 9 other locations."

Answered by AI

Does this research only include participants under the age of 30?

"According to the terms set by the researchers, the minimum age for this clinical trial is 2 years old while the maximum age is 18 years old."

Answered by AI

For what medical purpose is Baricitinib most commonly prescribed?

"Baricitinib is often used to treat patients who are hospitalized. Additionally, this medication can be useful in managing other conditions like coronavirus disease 2019 (covid‑19), ecmo treatment, and rheumatoid arthritis."

Answered by AI
~2 spots leftby Jul 2024