Pulmonary Injury After Intracerebral HemorrhagePhase 1/2BRIGHTNCT06548802
Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
A Phase 1/2 study testing Baricitinib in people with Pulmonary Injury After Intracerebral Hemorrhage, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Injury After Intracerebral Hemorrhage
- What is being tested?
- Baricitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to 31 Dec 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years old;
- 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.
- 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;
- There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease.
- Able and willing to sign written informed consent and comply with the requirements of the research protocol.
Who cannot join
- Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death;
- Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery;
- Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials;
- 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;
- Venous thromboembolism or risk of thrombosis;
- Life expectancy after enrollment ≤24h.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
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.
Read the detailed description
The objective of this study was to evaluate the efficacy and safety of baricitinib in patients with pulmonary injury after intracerebral hemorrhage.
- Being tested
- Baricitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment plus Baricitinib | Experimental | 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. Receives: Drug: Baricitinib |
| Standard treatment | No intervention | Given standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
- If the patient only required oxygen inhalation with the mask, SpO2≥97% of days without the mask were observed.
- If the patient has a tracheal intubation and ventilator-assisted breathing, observe the days needed for the patient to be removed from the ventilator.
Measured: From day 1 to day 30 after the lung injury occurrence.
Secondary outcomes (11)
Hematoma volume after intracerebral hemorrhage
- 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.
- If the patient is discharged from the hospital, a CT scan of the head should be performed on the 90th day if conditions permit.
Measured: At 1, 14, and 90 days after diagnosis.
NIHSS score
Assessed according to the National Institutes of Health Stroke Scale (NIHSS), the score ranges from 0 (asymptomatic) to 42 (death).
Measured: At 1, 3, 7, 14, 30 and 90 days after diagnosis.
mRS score
Assessed by mRS Score on a scale of 0 (asymptomatic) to 6 (dead).
Measured: At 90 days after diagnosis.
Severity score
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.)
Measured: At 1, 3, 7, 14, 30 days after diagnosis.
Murray's lung injury score
The assessment was based on Murray's lung injury score.
Measured: At 1, 3, 7, 14 days after diagnosis.
Days without ventilator support
- 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.
- 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.
Measured: From diagnosis to 30 days.
Length of ICU stay
- Duration of ICU.
- 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.
- In case of death, 30 days are recorded.
Measured: From diagnosis to 30 days.
APACHEⅡ score
Assessed according to acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) on a scale of 0-60.
Measured: At 1, 14, 30 days after diagnosis.
Total hospitalization days
Total hospitalization days.
Measured: From diagnosis to 90 days.
Mortality
Mortality of patients died because of the lung injury after ICH.
Measured: At 14, 30 and 90 days after diagnosis.
Incidence of treatment-emergent adverse events [safety and tolerability
Adverse events related to baricitinib are recorded.
Measured: From diagnosis to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start29 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Injury After Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University
- Responsible party
- Principal investigator, Qiang Liu, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548802
- Sponsor's protocol ID
- IRB2024-YX-067-01
- Acronym
- BRIGHT
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No