Print

Purpose

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved) - Should be hospitalized and exhibit at least one of the following predictors of mortality - Age >= 65 years - Current smoker (smoked >= 100 cigarettes in life and actively smoking) - Chronic obstructive pulmonary disease (COPD) - Diabetes - Hypertension - Coronary artery disease - Cerebrovascular accident (CVA) - Chronic renal disease (creatinine of >= 2 mg/dl) - Cancer - Patients that have C-reactive protein (CRP) >= 10 mg/L - D-dimer >= 0.5 mg/L - Procalcitonin >= 0.5 mg/L - Lactate dehydrogenase (LDH) >= upper limit of normal (ULN) - Patients or authorized family member willing to sign informed consent to participate in this study

Exclusion Criteria

  • Pregnant or lactating women - Hypersensitivity to tocilizumab - Patients or authorized family member unwilling to sign informed consent to participate in this study - Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (tocilizumab, standard of care) 		Patients receive tocilizumab IV every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
  • Other: Best Practice
    Receive standard of care
    Other names:
    • standard of care
    • standard therapy
  • Biological: Tocilizumab
    Given IV
    Other names:
    • Actemra
    • Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer
    • MRA
    • R-1569
    • RoActemra
Active Comparator
Arm II (standard of care) 		Patients receive standard of care.
  • Other: Best Practice
    Receive standard of care
    Other names:
    • standard of care
    • standard therapy

Recruiting Locations

More Details

NCT ID
NCT04361552
Status
Withdrawn
Sponsor
Emory University

Detailed Description

PRIMARY OBJECTIVE: I. To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2. SECONDARY OBJECTIVES: I. To decrease the rates of intensive care unit (ICU) transfer. II. To decrease the rate of invasive mechanical ventilation (MV). III. To decrease the length of ICU stay. IV. To decrease the rate of tracheostomy. V. Safety and efficacy of tociluzumab. VI. Biomarker assessment for response. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive tocilizumab intravenously (IV) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care. ARM II: Patients receive standard of care.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.