Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis

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