Status:
COMPLETED
Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
Lead Sponsor:
University of Chicago
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04331795
Start Date
April 4 2020
End Date
June 5 2020
Last Update
June 9 2022
Active Locations (1)
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1
University of Chicago Medicine
Chicago, Illinois, United States, 60637