Status:
TERMINATED
Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19
Lead Sponsor:
University of Chicago
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is...
Detailed Description
COVID-19's high mortality may be driven by hyperinflammation. Interleukin-6 (IL-6) axis therapies may reduce COVID-19 mortality. Retrospective analyses of tocilizumab in severe to critical COVID-19 pa...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age
- Approval from the patient's primary inpatient service
- Hospitalized
- Fever, documented in electronic medical record and defined as: T ≥ 38 degrees C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)
- Positive test for active SARS-CoV-2 infection
- Radiographic evidence of infiltrates on chest radiograph (CXR) or computed tomography (CT)
- Ability to provide written informed consent on the part of the subject or, in the absence of decisional capacity of the subject, an appropriate surrogate (e.g. a legally authorized representative).
Exclusion
- Concurrent use of invasive mechanical ventilation
- Concurrent use of vasopressor or inotropic medications
- Previous receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor in the year prior.
- Known history of hypersensitivity to tocilizumab.
- Diagnosis of end-stage liver disease or listed for liver transplant.
- Elevation of AST or ALT in excess of 10 times the upper limit of normal.
- Neutropenia (Absolute neutrophil count \< 500/uL).
- Thrombocytopenia (Platelets \< 50,000/uL).
- 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:
- Tofacitinib
- Baricitinib
- Upadacitinib
- Ruxolitinib
- Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months or less::
- 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
- Rituximab
- Sarilumab
- Secukinumab
- Tocilizumab
- Tositumumab
- Tremelimumab
- Urelumab
- Ustekinumab
- History of bone marrow transplantation (including chimeric antigen receptor T-cell) or solid organ transplant
- Known history of Hepatitis B or Hepatitis C (patients who have completed curative-intent anti-HCV treatments are not excluded from trial)
- Positive result on hepatitis B or C screening
- Known history of mycobacterium tuberculosis infection at risk for reactivation
- Known history of gastrointestinal perforation
- Active diverticulitis
- Multi-organ failure as determined by primary treating physicians
- Any other documented serious, active infection besides COVID-19 - including but not limited to: lobar pneumonia consistent with bacterial infection, bacteremia, culture-negative endocarditis, or current mycobacterial infection - at the discretion of primary treating physicians
- Pregnant patients or nursing mothers
- Patients who are unable to discontinue scheduled antipyretic medications, either as monotherapy (e.g., acetaminophen or ibuprofen \[aspirin is acceptable\]) or as part of combination therapy (e.g., hydrocodone/acetaminophen, aspirin/acetaminophen/caffeine \[Excedrin®\])
- CRP \< 40 mg/L
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2025
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04479358
Start Date
September 10 2020
End Date
February 10 2025
Last Update
June 5 2025
Active Locations (1)
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1
University of Chicago Medicine
Chicago, Illinois, United States, 60637