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Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

TerminatedPhase 2

Sponsor: University of Chicago

Conditions: COVID-19

Interventions: Tocilizumab, Tocilizumab, Standard of Care, Standard of Care

Countries: United States

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 critical. We conducted an open-label, randomized, controlled trial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg). Randomization was stratified on remdesivir and corticosteroid at enrollment. The primary outcome was the time to recovery. The key secondary outcome was 28-day mortality.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Chicago, Illinois, United States