Clinical trial NCT04361552: Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
Official title: Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cerebrovascular Accident
Chronic Obstructive Pulmonary Disease
Chronic Renal Failure
Coronary Artery Disease
Diabetes Mellitus
Malignant Neoplasm
SARS Coronavirus 2 Infection
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 7-day length of invasive mechanical ventilation (MV)
timeFrame: Up to 7 days
measure: 30-day mortality rate
timeFrame: Up to 30-day after randomization
Secondary outcomes:
measure: Rate of intensive care (ICU) transfer
timeFrame: Up to 2 years
measure: Rate of invasive mechanical ventilation
timeFrame: Up to 2 years
measure: Rate of tracheostomy
timeFrame: Up to 2 years
measure: Length of ICU stay
timeFrame: Up to 2 years
measure: Length of hospital stay
timeFrame: Up 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Ajay K Nooka
role: PRINCIPAL_INVESTIGATOR
References: