Not recruiting

Study of Baricitinib in Children Aged 1 to 17 Hospitalized with COVID-19

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Baricitinib in children who are hospitalized with COVID-19. COVID-19, also known as the coronavirus infection, is a disease caused by a virus that can lead to respiratory problems and other health issues. The medication being tested, Baricitinib, is provided in the form of an oral suspension, which means it is a liquid that is taken by mouth.

The purpose of this study is to understand how Baricitinib behaves in the body of pediatric patients, which includes children from 1 year to less than 18 years old. The study will look at how the medication is absorbed, distributed, and eliminated by the body. This information is important to ensure the safety and effectiveness of the treatment in young patients who are receiving oxygen therapy due to their COVID-19 infection.

During the study, participants will receive Baricitinib for a period of up to 14 days. Researchers will monitor the children closely to gather information about the medication's safety and how it moves through the body. This will help determine the best way to use Baricitinib in treating children with COVID-19 in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must be hospitalized with a confirmed COVID-19 infection and require oxygen therapy.
Step 2
Medication administration
The participant will receive Baricitinib, which is an oral suspension. This medication is taken by mouth.
The dosage and frequency of Baricitinib will be determined by the medical team based on the participant's specific needs and condition.
Step 3
Monitoring and assessments
Throughout the study, the participant's response to Baricitinib will be closely monitored. This includes measuring the concentration of the medication in the blood over time to understand how the body processes it.
The primary focus is on the pharmacokinetics, which involves studying the area under the concentration curve (AUC) and the maximum concentration (Cmax) of Baricitinib.
Step 4
Completion of the study
The study is estimated to conclude by December 31, 2024. The participant will continue to be monitored until the end of the study period to ensure safety and gather necessary data.

Who can join the trial?

5 criteria

Participants must be hospitalized with a coronavirus (COVID-19) infection. This means they need to be staying in a hospital because of the virus.
Participants must need oxygen therapy. This means they require extra oxygen to help them breathe better.
Participants must be at least 2 years old. This means they need to be 2 years of age or older.
Both female and male participants are eligible. This means the study is open to all genders.
The study includes people who might be considered vulnerable. This means it includes individuals who might need extra care or protection.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Regional De La Citadelle
Verified
Liege, Belgium
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Baricitinib is a medication being studied for its effects in children with COVID-19. It is used to help reduce inflammation and manage the immune response in patients. In this trial, researchers are looking at how the body processes this medication in children who are hospitalized with COVID-19.

Baricitinib

What is already known about the treatment

Baricitinib – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness and safety in treating COVID-19, particularly in pediatric patients. Baricitinib is primarily used to treat conditions like rheumatoid arthritis and is being explored for its potential in managing COVID-19 symptoms. It works by inhibiting specific enzymes known as Janus kinases, which play a role in the inflammatory process. Baricitinib is classified as a Janus kinase inhibitor, which helps reduce inflammation and modulate the immune response.

Investigated diseases

COVID-19 – COVID-19 is a respiratory illness caused by the coronavirus SARS-CoV-2. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can range from mild symptoms like fever, cough, and fatigue to more severe respiratory issues. In some cases, it can lead to complications such as pneumonia or acute respiratory distress syndrome. The progression of the disease varies widely among individuals, with some recovering quickly and others experiencing prolonged symptoms. The virus can also affect other organs, leading to a variety of symptoms beyond the respiratory system.