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

NCT06548802 | Recruiting Phase 1

• 1 other identifier: IRB2024-YX-067-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Injury After Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Recovery time

  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 Outcomes (11)

• Hematoma volume after intracerebral hemorrhage

  At 1, 14, and 90 days after diagnosis.

• NIHSS score

  At 1, 3, 7, 14, 30 and 90 days after diagnosis.

• mRS score

  At 90 days after diagnosis.

• Severity score

  At 1, 3, 7, 14, 30 days after diagnosis.

• Murray's lung injury score

  At 1, 3, 7, 14 days after diagnosis.

Study Arms (2)

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.

Drug: Baricitinib

Standard treatment

NO INTERVENTION

Given standard treatment.

Interventions

Baricitinib DRUG

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.

Standard treatment plus Baricitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Interventions

baricitinib

Central Study Contacts

Qiang Liu, M.D, Ph.D.

CONTACT

+86 15022439149; qliu@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Neurology

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

CN (1)