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IL-6 Receptor Inhibitor

Tocilizumab for Acute Chest Syndrome

Phase 2

Recruiting

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months (admission date to discharge date)

Awards & highlights

Study Summary

This trial is studying if tocilizumab, used to treat rheumatoid arthritis & COVID-19, can help sickle cell patients with acute chest syndrome. It's hoped it'll improve oxygen status, clinical outcomes, and lab markers.

Who is the study for?

This trial is for adults over 18 with sickle cell disease (various types). It's not for those who are pregnant, breastfeeding, or on certain immune-targeting drugs like Bruton's tyrosine kinase inhibitors or JAK2 agents. Also excluded are patients who've had specific biologic immunosuppressants in the last 6 months.Check my eligibility

What is being tested?

Researchers are testing a low dose of Tocilizumab to treat acute chest syndrome in sickle cell patients. They want to see if it improves oxygen levels, clinical outcomes, and lab markers since IL-6 is high in these patients' sputum.See study design

What are the potential side effects?

Tocilizumab can cause side effects such as infections due to weakened immunity, liver enzyme elevations indicating potential liver damage, infusion reactions during treatment administration, and possibly digestive disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months (admission date to discharge date)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months (admission date to discharge date)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months (admission date to discharge date) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time-weighted SaO2/FiO2 ratio

Secondary outcome measures

Intensive Care Unit (ICU) transfer rate

Length of stay

Mortality rate

+2 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

Inpatient admission

fatigue

agranulocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Tocilizumab

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early TocilizumabExperimental Treatment1 Intervention

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.

Group II: Delayed TocilizumabActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,549 Total Patients Enrolled

Austin Wesevich, MDStudy DirectorUniversity of Chicago

Media Library

Tocilizumab (IL-6 Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05640271 — Phase 2

Sickle Cell Disease Research Study Groups: Delayed Tocilizumab, Early Tocilizumab

Sickle Cell Disease Clinical Trial 2023: Tocilizumab Highlights & Side Effects. Trial Name: NCT05640271 — Phase 2

Tocilizumab (IL-6 Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05640271 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How effective is Early Tocilizumab in mitigating risk for patients?

"While there is minimal evidence confirming the efficacy of early tocilizumab, our team at Power assessed its safety as a 2 due to existing data."

Answered by AI

Is the enrollment period for this clinical trial still underway?

"As evidenced by clinicaltrials.gov, this trial is currently accepting applicants and was initially posted on April 10th 2023 with the most recent update occuring four days prior."

Answered by AI

How many participants are recruited for this trial's protocol?

"Indeed, clinicaltrials.gov confirms that this medical trial is at present recruiting participants. It was initially posted on April 10th 2023 and its details were recently refreshed as of April 6th 2023. The study seeks 200 patients from a single location for enrollment purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tocilizumab for Acute Chest Syndrome

2023. "Tocilizumab for Acute Chest Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05640271.