Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19 (NCT04479358) | Clinical Trial Compass
TerminatedPhase 2
Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19
Stopped: Lack of recruitment of patients into the trial
United States85 participantsStarted 2020-09-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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…