Covid-19 Living Data

Trial NCT04479358
Publication COVIDOSE-2, Unpublished, 2021 ( )
Dates: 2020-09-10 to 2021-01-31
Funding: Public/non profit (University of Chicago )
Conflict of interest: *

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / USA Follow-up duration (days): 28
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
Interventions
	Treatment Tocilizumab 40mg or 120mg once off
	Control Standard care ( / ) Definition of Standard care: *
Participants
	Randomized 28 participants (n₁=20 / n₂= 8)
	Characteristics of participants N=28 Mean age : NR 19 males Severity : Mild: n=0 / Moderate: n=/ Severe: n= Critical: n=0
Primary outcome
	In the register Time to Recovery [ Time Frame: 28 days ]
	In the report NR
Documents available	Protocol NR Statistical plan NR Data-sharing stated
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Low
General comment	The study is not published yet. Data presented was extracted from study registry and The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group "Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis." JAMA. 2021;326(6):499–518. The authors have been contacted in order to obtain the results.