Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT04479358
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04479358
Study Brief:
Protocol Section:
NCT04479358