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Tocilizumab for Acute Chest Syndrome

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Oct 2026 → Dec 2026
See other at-risk trials from University of Chicago

Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 4 more changesShow less
    • Primary completion pushed from Oct 2026 to Dec 2026
    • Study completion pushed from Mar 2027 to Jun 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 5 entries
  2. Primary completion pushed from Jul 2026 to Oct 2026
    • Study completion pushed from Jan 2027 to Mar 2027
    v9
  3. Primary completion date: Apr 2026 to Jul 2026v8
  4. Primary completion date: Apr 2025 to Apr 2026
    • Study completion date: Jan 2026 to Jan 2027
    v7
  5. Eligibility criteria expanded, about 64 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria shortened, about 80 wordsv5
  2. Secondary endpoints expanded, about 18 wordsv4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Jan 2023 to Apr 10, 2023
    • Study sites: 0 to 1
    • Primary completion date: Jan 2025 to Apr 2025
    • Study description expanded, about 97 words
    • Study title expanded, about 2 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.
Trial Details
NCT Number NCT05640271
Lead Sponsor University of Chicago
Conditions
(from sponsor)		 Sickle Cell Disease, Acute Chest Syndrome
Related terms Acute Chest Syndrome, Anemia, Sickle Cell
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov