COVID drug trial for kids halted early

NCT ID NCT05074420

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tested the drug baricitinib in children aged 1 to 18 who were hospitalized with COVID-19 and needed extra oxygen. The goal was to see if the drug was safe and how it worked in kids. Only 6 children took part before the study was stopped early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

6 people

The number who actually took part.

Started

Dec 2021

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Hospitalized with coronavirus (SARS-CoV-2) infection. * Male or female participants from 1 to \<18 years of age. * Requires supplemental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment. * Supplemental oxygen including but not limited to: nasal cannula, mask, high flow devices, CPAP/BiPAP, invasive mechanical ventilation as well as ECMO. Exclusion Criteria: * Are receiving biologic treatments (such as Tumor Necrosis Factor \[TNF\] inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferon, or Janus kinase (JAK) inhibitors); or are receiving other immunosuppressants such that, in the opinion of the investigator, participating in the study would put the participant at an unacceptable risk of immunosuppression. Note: A washout period is required prior to screening. * Are receiving strong inhibitors of Organic Anion Transporter 3 (OAT3) (such as probenecid) that cannot be discontinued at study entry. * Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required). * Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. * Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of non-live (inactivated) vaccinations are allowed for all participants. * Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry. * Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product. * Have a history of venous thromboembolism (VTE) (deep vein thrombosis \[DVT\] and/or pulmonary embolism \[PE\]) or considered high risk of VTE (DVT/PE). * Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry. * Have neutropenia (absolute neutrophil count \<1000 cells/microliters). * Have lymphopenia (absolute lymphocyte count \<200 cells/microliters). * Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times AAULN. * Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\]) \<40 milliliter/minute/1.73 meters squared. * Have a known hypersensitivity to baricitinib or any of its excipients. * Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28. * Are pregnant, or intend to become pregnant or breastfeed during the study. * Are, in the opinion of the investigator or sponsor, at risk of immunosuppression or otherwise unsuitable for inclusion in the study. * Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®. * Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, 17201130, Brazil

  • Centro de Pesquisa Sao Lucas

    Campinas, 13034-685, Brazil

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Complejo Hospitalario de Navarra

    Pamplona, 31009, Spain

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 06720, Mexico

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

    Vitoria-Gasteiz, 01009, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90410000, Brazil

  • Instituto Nacional de Pediatria

    Mexico City, 04530, Mexico

  • Instituto de Pesquisa clinica de Campinas

    Campinas, 13060-080, Brazil

  • Pesquisare Saude

    Santo André, 09080-110, Brazil

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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