Baricitinib: A Review of Pharmacology, Safety, and Emerging Clinical Experience in COVID-19.
Sarah C J Jorgensen, Christopher L Y Tse, Lisa Burry...
https://pubmed.ncbi.nlm.nih.gov/32542785/Actively Recruiting
Led by Tang-Du Hospital · Updated on 2026-04-13
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the effects of baricitinib on people with moderate to severe traumatic intracerebral hemorrhage or contusions. This is a multicenter randomized control trial involving participants who have a radiological diagnosis of traumatic brain injury with an initial Glasgow Coma Scale GCS score between 5 and 12. The study aims to compare baricitinib combined with standard treatment to standard treatment alone to see if it improves patient outcomes. Participants will be divided into two groups. One group will receive the standard treatment according to current guidelines for traumatic brain injury. The other group will receive standard treatment plus baricitinib, given orally or through a nasogastric tube at a dose of 4 mg daily for 14 consecutive days starting soon after injury. The trial includes a control group and an experimental group to assess the effects of baricitinib. During the study, participants will be monitored for clinical improvement up to 180 days after injury. Researchers will assess outcomes like mortality rates at various time points, coma severity, and Glasgow Outcome Scale scores. They will also measure serum inflammatory factors, brain edema volume, intracranial pressure, and incidence of pneumonia within the first days to weeks after injury. Participants will undergo CT scans and laboratory tests as part of the monitoring process. The study involves follow-up evaluations to track recovery and safety over several months.
CONDITIONS
Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions
S
Shunnan Ge, M.D,Ph.D
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Tang-Du Hospital
Lead Sponsor
Qianxian People's Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive standard treatment for traumatic brain injury. Those in the experimental group also take baricitinib orally at a dosage of 4mg daily for 14 consecutive days after brain injury.
Daily administration for 14 days
Duration - Up to 180 days
Participants are monitored for clinical improvement and outcomes following treatment, including mortality and neurological function assessments.
Follow-up visits at 90 and 180 days
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Qianxian People's Hospital
Collaborating Sponsor