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RecruitingPhase 2

Tocilizumab for Acute Chest Syndrome

Low-Dose Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a low dose of tocilizumab in people with sickle cell disease who are in the hospital with acute chest syndrome, a serious lung problem. Researchers will study how the drug affects oxygen levels, health outcomes, and lab test results.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 12 or older.
  • Have sickle cell disease of one of these types: Hb SS, Hb SC, Hb Sb+, or Hb Sb0.

Who can't join

  • Are pregnant or breastfeeding.
  • Have had gene therapy or a stem cell transplant.
  • Are currently in another clinical trial involving an FDA-regulated drug or biologic medicine.
  • Have low neutrophils (infection-fighting white blood cells): below 1,000/mm³; or low platelets (cells that help blood clot): below 50,000/mm³.
  • Have AST or ALT liver test results more than 10 times the highest normal level.
  • Have a history of tuberculosis (TB) or a positive PPD skin test for TB.
  • Currently take acalabrutinib, ibrutinib, zanubrutinib, baricitinib, ruxolitinib, tofacitinib, or upadacitinib.
  • Have received any of the study’s listed biologic medicines that suppress the immune system, or their highly similar versions, in the past 6 months. Ask the study team to check your medicines.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults ≥ 12 years of age * Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0) Exclusion Criteria: * 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: Abatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab

Study sites (1)

IL