Purpose

The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.

Condition

Eligibility

Eligible Ages
Between 18 Years and 95 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ii. Hospitalized with COVID-19 pneumonia, based on chest X-ray or CT scan AND iii. Evidence of hyperinflammation: IL-6>40pg/mL (if available) OR CRP >2 mg/dL OR ferritin >2000 ng/mL AND iv. One or more of the following: impending need for requiring invasive or non-invasive mechanical ventilation OR shock requiring vasopressor (without evidence of bacterial / fungal infection) OR need for extracorporeal membrane oxygenation (ECMO) OR severe, refractor ARDS (PaO2/FiO2<200 mmHg)

Exclusion Criteria

Known severe allergic reactions to tocilizumab or other monoclonal antibodies - Active tuberculosis infection based on history - Suspected active bacterial, fungal, viral, or other infection (besides COVID-19) - In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - Have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) with the past 6 months - Participating in other drug clinical trials (participation in COVID-19 trials allowed) - Self-reported pregnant or breastfeeding - Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at baseline - Absolute neutrophil count (ANC) < 1000/mL at baseline - Platelet count < 50,000/mL at baseline

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tocilizumab (TCZ) Arm
Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen.
  • Drug: Tocilizumab
    Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
    Other names:
    • Actemra
Placebo Comparator
Placebo Arm
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
  • Drug: Placebo
    Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.

Recruiting Locations

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Todd Seto, MD
808-354-3533
tseto@queens.org

More Details

NCT ID
NCT04412772
Status
Unknown status
Sponsor
Queen's Medical Center

Study Contact

Todd Seto, MD
808 354-3533
tseto@queens.org

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.