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:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT04331795
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years of age
* Approval from the patient's primary service
* Admitted as an inpatient to University of Chicago Medicine
* Fever, documented in electronic medical record and defined as: T ≥ 38\*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 (patients receiving non-invasive mechanical ventilation \[CPAP, BiPap, HHFNC\] are eligible)
* Concurrent use of vasopressor or inotropic medications
* Previous receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor.
* Known history of hypersensitivity to tocilizumab.
* Patients who are actively being considered for a study of an antiviral agent that would potentially exclude concurrent enrollment on this study.
* Patients actively receiving an investigational antiviral agent in the context of a clinical research study.
* Diagnosis of end-stage liver disease or listed for liver transplant.
* Elevation of AST or ALT in excess of 5 times the upper limit of normal.
* Neutropenia (Absolute neutrophil count \< 500/uL).
* Thrombocytopenia (Platelets \< 50,000/uL).
* On active therapy with a biologic immunosuppressive agent, which include the following biologics and any biosimilar versions thereof:
* Alemtuzumab
* Blinatumomab
* Brentuximab
* Daratumumab
* Elotuzumab
* Ibritumomab
* Obinutuzumab
* Ofatumumab
* Ocrelizumab
* Rituximab
* Inotuzumab
* Gemtuzumab
* Tositumumab
* Moxetumomab
* Polatuzumab
* Abatacept
* Adalimumab
* Belimumab
* Certolizumab
* Eculizumab
* Etanercept
* Golimumab
* Infliximab
* Ixekizumab
* Rituximab
* Sarilumab
* Secukinumab
* Tocilizumab
* Ustekinumab
* On active therapy with a JAK2-targeted agent, which include the following:
* Tofacitinib
* Baricitinib
* Upadacitinib
* Ruxolitinib
* History of bone marrow transplantation or solid organ transplant.
* Known history of Hepatitis B or Hepatitis C.
* Known history of mycobacterium tuberculosis infection at risk for reactivation.
* Known history of gastrointestinal perforation or active diverticulitis.
* Multi-organ failure as determined by primary treating team
* Any other documented serious, active infection besides COVID-19.
* Pregnant patients
* 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 (or ug/mL)
Patients will be assigned to Group A if:
● C-reactive protein (CRP) ≥ 75 ug/mL
AND
Any one of the following criteria are met:
* Previous ICU admission
* Previous non-elective intubation
* Admission for heart failure exacerbation within the past 12 months
* History of percutaneous coronary intervention (PCI)
* History of coronary artery bypass graft (CABG) surgery
* Diagnosis of pulmonary hypertension
* Baseline requirement for supplemental O2
* Diagnosis of interstitial lung disease (ILD)
* Admission for chronic obstructive pulmonary disease (COPD) exacerbation within the past 12 months
* Asthma with use of daily inhaled corticosteroid
* History of pneumonectomy or lobectomy
* History of radiation therapy to the lung
* History of HIV
* Cancer of any stage and receiving active treatment (excluding hormonal therapy)
* Any history of diagnosed immunodeficiency
* End-stage renal disease (ESRD) requiring peritoneal or hemodialysis
* History of cerebrovascular accident with residual, patient-reported neurologic deficit
* BMI \>30 kg/m2
* Supplemental O2 requirement \> 6L in the 24 hours prior to enrollment and tocilizumab administration
All other eligible patients assigned to Group B
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04331795
Study Brief:
Protocol Section:
NCT04331795