Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury (BRIGHT)

August 7, 2024 updated by: Qiang Liu, Tianjin Medical University General Hospital
Some patients with intracerebral hemorrhage will develop severe lung injury such as respiratory distress syndrome. Baricitinib has been approved by the FDA for severe pneumonia caused by the coronavirus, and has been used in the treatment of hospitalized patients with COVID-19. Baricitinib significantly reduced the risk of death and shortened the length of stay in COVID-19 patients. According to clinical observations, there was no significant increase in deaths or infections due to non-COVID-19 causes during recovery, nor was there a significant increase in thrombosis. Excessive inflammatory factors release can cause inflammatory storms that damage lung cells, lead to lung injury, and eventually lead to respiratory failure, respiratory distress syndrome and other conditions, endangering life safety. Studies have shown that Baricitinib can inhibit the production of excessive pro-inflammatory cytokines by lung macrophages through the JAK pathway and reduce lung injury caused by inflammatory storms. Therefore, in patients with acute stroke with lung infection or severe lung injury, short-term use of baricitinib will help to reduce lung injury and promote the recovery of neurological function, and shorten the length of hospital stay. However, there is currently a lack of effective clinical evidence of baricitinib in the treatment of lung injury after intracerebral hemorrhage, and further research is needed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study was to evaluate the efficacy and safety of baricitinib in patients with pulmonary injury after intracerebral hemorrhage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Qiang Liu, M.D, Ph.D.
  • Phone Number: +86 15022439149
  • Email: qliu@tmu.edu.cn

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Qiang Liu, M.D.,Ph.D.
          • Phone Number: +8615022439149
          • Email: qliu@tmu.edu.cn
        • Principal Investigator:
          • Qiang Liu, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients ≥ 18 years old;
  2. The diagnosis was non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage (including supratentorial deep hemorrhage, lobal hemorrhage, cerebellar hemorrhage, brainstem hemorrhage, intracerebral hemorrhage, intracerebral parenchymal hemorrhage into ventricle, subarachnoid hemorrhage), which was confirmed by CT scan.
  3. Onset of ARDS within 48 hours to 7 days after admission (as defined by Berlin) : ① Patients with moderate to severe ARDS symptoms or progressive dyspnea within 7 days (100mmHg < PaO2/FiO2≤200, PEEP≥5cmH2O); ② Hypoxemia: SpO2/FiO2≤315mmHg and SpO2≤97%, and could not be explained by acute heart failure and fluid overload; ③ Need intubation or mechanical ventilation; ④ Imaging findings (chest X-ray/chest CT) : infiltration of both lungs, cannot be completely explained by pleural effusion, lobar/whole lung atelectasis and nodule;
  4. There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease.
  5. Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Exclusion Criteria:

  1. Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death;
  2. Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery;
  3. Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials;
  4. Combine the following cases that are not eligible to participate in this study: ① Severe hepatic insufficiency (ALT/AST > 5xULN); ② Moderate to severe renal insufficiency (eGFR < 60ml/min/1.73m2); ③ Undergoing hemodialysis or hemofiltration; ④ Neutrophils or lymphocytes decreased (Absolute neutrophil count < 1000/ul, absolute lymphocyte count < 200/ul); ⑤ During pregnancy or childbirth;
  5. Venous thromboembolism or risk of thrombosis;
  6. Life expectancy after enrollment ≤24h.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard treatment plus Baricitinib
On standard treatment, Baricitinib was given 4mg once daily, with the first dose taken within 24 hours of the appearance of lung injury and continued for 14 days.
Drug: Baricitinib
Baricitinib was given 4mg once daily, with the first dose taken within 24 hours of the appearance of lung injury and continued for 14 days.
No Intervention: Standard treatment
Given standard treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: From day 1 to day 30 after the lung injury occurrence.
  1. If the patient only required oxygen inhalation with the mask, SpO2≥97% of days without the mask were observed.
  2. If the patient has a tracheal intubation and ventilator-assisted breathing, observe the days needed for the patient to be removed from the ventilator.
From day 1 to day 30 after the lung injury occurrence.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hematoma volume after intracerebral hemorrhage
Time Frame: At 1, 14, and 90 days after diagnosis.
  1. CT images of the head were obtained at 1, 14, and 90 days after diagnosis. CT scan within 24 hours after diagnosis was used as the baseline analysis.
  2. If the patient is discharged from the hospital, a CT scan of the head should be performed on the 90th day if conditions permit.
At 1, 14, and 90 days after diagnosis.
NIHSS score
Time Frame: At 1, 3, 7, 14, 30 and 90 days after diagnosis.
Assessed according to the National Institutes of Health Stroke Scale (NIHSS), the score ranges from 0 (asymptomatic) to 42 (death).
At 1, 3, 7, 14, 30 and 90 days after diagnosis.
mRS score
Time Frame: At 90 days after diagnosis.
Assessed by mRS Score on a scale of 0 (asymptomatic) to 6 (dead).
At 90 days after diagnosis.
Severity score
Time Frame: At 1, 3, 7, 14, 30 days after diagnosis.
Assessed by score on a scale of 0 (asymptomatic) to 8 (dead). Scores were depended on the treatment needed (Nasal tube = 1, mask = 1, non-invasive positive pressure ventilation = 1, trachea cannula = 1, glucocorticoids treatment =1, prone position ventilation = 1, ECMO= 1, death = 1.)
At 1, 3, 7, 14, 30 days after diagnosis.
Murray's lung injury score
Time Frame: At 1, 3, 7, 14 days after diagnosis.
The assessment was based on Murray's lung injury score.
At 1, 3, 7, 14 days after diagnosis.
Days without ventilator support
Time Frame: From diagnosis to 30 days.
  1. For patients with tracheal intubation and ventilator-assisted breathing, the tracheal intubation was removed after treatment, and only required mask oxygen inhalation or high flow oxygen inhalation days until discharge.
  2. If the patient has been discharged from the hospital and is still on no-oxygen, mask oxygen, or high-flow oxygen at the 30th day of follow-up, 30 days is recorded.
From diagnosis to 30 days.
Length of ICU stay
Time Frame: From diagnosis to 30 days.
  1. Duration of ICU.

  2. If the patient has not reached 30 days by the time of discharge, the 30-day telephone follow-up:

    • If the patient did not continue ICU treatment, the actual number of days was recorded;
    • If the patient remains hospitalized in the ICU, 30 days is recorded.
  3. In case of death, 30 days are recorded.
From diagnosis to 30 days.
APACHEⅡ score
Time Frame: At 1, 14, 30 days after diagnosis.
Assessed according to acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) on a scale of 0-60.
At 1, 14, 30 days after diagnosis.
Total hospitalization days
Time Frame: From diagnosis to 90 days.
Total hospitalization days.
From diagnosis to 90 days.
Mortality
Time Frame: At 14, 30 and 90 days after diagnosis.
Mortality of patients died because of the lung injury after ICH.
At 14, 30 and 90 days after diagnosis.
Incidence of treatment-emergent adverse events [safety and tolerability
Time Frame: From diagnosis to 90 days.
Adverse events related to baricitinib are recorded.
From diagnosis to 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2024-YX-067-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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