Baricitinib for the Lung Injury Following Spontaneous SAH

Sponsor
Tang-Du Hospital
Study ID
NCT06439615
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Spontaneous Subarachnoid Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib 4 MG — DRUG
    Baricitinib will be administered orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH.
  • Standard treatment — OTHER
    Participants will receive standard treatment and care according to the current management guidelines for subarachnoid hemorrhage.

Study Details

The present study is a randomized, parallel control, and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage (SAH). The research protocol incorporates an adaptive design, allowing for modifications to key elements such as the sample size enrolled during interim analysis.

Key Dates

Start date
Aug 1, 2024
Status verified
May 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Sham Comparator: Control group
    Participants will receive standard treatment and care according to the current management guidelines for SAH.
  • Experimental: Baricitinib group
    In addition to receiving standard treatment and care, baricitinib will be administrated orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH.

Primary Outcome Measure

The incidence of pneumonia [ Time Frame: up to 14 days ]

Central Contacts