COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04479358

Pankti D Reid

Not reported

2020-07-21

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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).

- 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

2

University of Chicago

18

100

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

75

Time to Recovery

None

Phase 2

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