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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Adults ≥ 12 years of age

• Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
Contact Information
Primary
Austin Wesevich, MD
austin.wesevich@uchicagomedicine.org
773-834-6732
Backup
Gabrielle Lapping-Carr, MD
glappingcarr@uchicago.edu
773-702-6808
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2027-01
Participants
Target number of participants: 200
Treatments
Experimental: Early Tocilizumab
This arm will receive tocilizumab 80 mg at the time of acute chest syndrome diagnosis and subsequent randomization. Then, two days later, they will receive 50 mL of normal saline.
Active_comparator: Delayed Tocilizumab
This arm will receive 50 mL of normal saline at the time of acute chest syndrome diagnosis and subsequent randomization. Then, two days later, they will receive tocilizumab 80 mg. Thus, this delayed arm will serve as a placebo comparator for the first 48 hours and then as an active comparator for the remaining duration on study.
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov