Can a smaller dose of arthritis drug tame COVID-19 lung inflammation?
NCT ID NCT04479358
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a low dose of tocilizumab, a drug used for arthritis, could help hospitalized COVID-19 patients with lung inflammation who were not on a breathing machine. The goal was to see if it sped up recovery and reduced deaths. The trial was stopped early, but results may help guide dosing of this drug during shortages.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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85 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Chicago Medicine
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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