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Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease

This study is looking at whether a medication called tocilizumab can help treat acute chest syndrome (a serious lung complication) in people with sickle cell disease. Tocilizumab works by blocking a protein called IL-6, which is often high in acute chest syndrome. Researchers hope this will improve breathing and other symptoms. You may be able to join if you are 12 years or older, have sickle cell disease, and are currently hospitalized with acute chest syndrome. People who are pregnant, breastfeeding, or have had gene therapy or a stem cell transplant cannot participate. The main goal is to see how tocilizumab affects your oxygen levels over four days.

Study design
This is a randomized, placebo-controlled, double-blinded study, meaning participants will randomly receive either tocilizumab or a placebo (inactive substance) without knowing which they received. The study plans to enroll 200 participants.
What's involved
Participants will receive one dose of tocilizumab and one dose of normal saline (placebo) intravenously, given 48 hours apart. Oxygenation data, clinical information, lab tests, and patient-reported outcomes will be collected during hospitalization.
Compensation
Not stated in the trial record.
Follow-up
Oxygen levels will be monitored for a total of 4 days (Day 0 to Day 4) after treatment.

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NCT05640271

Tocilizumab for Acute Chest Syndrome

Recruiting
PHASE2Ages 12+InterventionalTreatment
University of Chicago
~200 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Tocilizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time-weighted SaO2/FiO2 ratio
Measured over Total of 4 days (Day 0 to Day 4)

Conditions

Sickle Cell Disease
Acute Chest Syndrome

Explore related trials

Acute Chest SyndromeSickle Cell Disease

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Austin Wesevich, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Austin Wesevich, MD
[email protected]
773-834-6732
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults ≥ 12 years of age
Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

Exclusion

Pregnant patients or breastfeeding mothers.
Prior treatment with gene therapy or a stem cell transplant.
Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.
Current neutropenia (absolute neutrophil count \< 1000/mm\^3)
Current thrombocytopenia (platelet count \< 50,000 mm\^3)
Aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 10 times the upper limit of normal (ULN)
History of tuberculosis (TB).
Positive purified protein derivative (PPD) TB screening test.
On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib
On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib
Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months:

What this trial measures

  • Time-weighted SaO2/FiO2 ratioTotal of 4 days (Day 0 to Day 4)

    Oxygenation data will be obtained as part of routine clinical care. All changes in pulse oximetry measurement that are documented in the chart will be recorded in an oxygen saturation case report form with the date and time from Day 0 to Day 4. These peripheral oxygen saturation (SpO2) measurements will serve as surrogates for SaO2. Additionally, all changes in the route of supplemental oxygen delivery, rate of supplemental oxygen delivery, and fraction of inspired oxygen (FiO2) will be recorded in a corresponding case report form with the date and time from Day 0 to Day 4. The time-weighted SaO2/FiO2 ratio, our primary endpoint, will be calculated based on these two case report forms.