CLINICAL TRIAL / NCT05640271

Tocilizumab for Acute Chest Syndrome

Interventional
Recruiting
NCT05640271

Eligibility Details Visit Clinicaltrials.gov

Contact Information

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

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.

Detailed Description

In this randomized, placebo-controlled, double-blinded phase II study, enrolled patients admitted to the University of Chicago who are diagnosed with acute chest syndrome will receive one dose of tocilizumab 80 mg IV and one normal saline placebo dose. The order of these doses will be randomized at a 1:1 ratio. After collecting oxygenation data as a baseline for 8 hours, patients will then receive tocilizumab versus placebo as their early dose and then the opposite (placebo versus tocilizumab) 48 hours later. Clinical, laboratory, and patient-reported outcome data will be collected during their admission and compared between arms.

Eligibility Details

Gender
All

Age Group
12 Years and up

Accepting Healthy Volunteers
No

Inclusion Criteria: - Adults â‰¥ 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 &lt; 1000/mm^3) - Current thrombocytopenia (platelet count &lt; 50,000 mm^3) - Aspartate aminotransferase (AST) or alanine transaminase (ALT) &gt; 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