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WithdrawnPhase 3NCT04361552
Official study title

Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBest Practice and Tocilizumab

The study team can explain what participation involves.

Who it may be forCerebrovascular Accident · Chronic Obstructive Pulmonary Disease

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 18, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Emory University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Emory University
Interventions being studied
Other: Best Practice; Biological: Tocilizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 18, 2020. Always confirm current availability with the study team.

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