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Tocilizumab for Coronavirus Pneumonia (EMPACTA Trial)
Phase 3
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized
COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 60
Awards & highlights
EMPACTA Trial Summary
This trial will compare the efficacy and safety of tocilizumab (TCZ) to a placebo in hospitalized participants with COVID-19 pneumonia receiving standard of care.
Eligible Conditions
- Coronavirus Pneumonia
EMPACTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMPACTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
Secondary outcome measures
Clinical Status on 7-Category Ordinal Scale at Day 28
Mortality Rate by Day 28
Percentage of Participants With Adverse Events
+3 moreSide effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo
EMPACTA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TocilizumabExperimental Treatment1 Intervention
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,364 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,162 Total Patients Enrolled
Frequently Asked Questions
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