This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
377
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.
Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
Cumulative proportion is measured as a percentage of participants meeting the endpoint.
Time frame: Up to Day 28
Time to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or >/= 2 Liters (L) Supplemental Oxygen)
Time frame: Up to Day 28
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
Clinical status was assessed using a 7-category ordinal scale: 1. \- Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or \</=2 liters supplemental oxygen) 2. \- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. \- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. \- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. \- ICU, requiring intubation and mechanical ventilation 6. \- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support 7. \- Death
Time frame: Up to Day 28
Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)
Time frame: Up to Day 28
Mortality Rate by Day 28
Time frame: Up to Day 28
Clinical Status on 7-Category Ordinal Scale at Day 28
Clinical status was assessed using a 7-category ordinal scale: 1. \- Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or \</=2 liters supplemental oxygen) 2. \- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. \- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. \- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. \- ICU, requiring intubation and mechanical ventilation 6. \- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support 7. \- Death
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Banner - University Medical Center Phoenix; In-Patient Pharmacy
Phoenix, Arizona, United States
Univ of AZ Coll of Med
Tucson, Arizona, United States
El Centro Regional Medical Center
El Centro, California, United States
eStudySite
La Mesa, California, United States
Highland Hospital Oakland
Oakland, California, United States
St. Joseph'S Hospital
Orange, California, United States
San Leandro Hospital; Inpatient Pharmacy
San Leandro, California, United States
Larkin Community Hospital Palm Springs Campus (Hialeah)
Hialeah, Florida, United States
Miami Veterans Administration Healthcare System - NAVREF
Miami, Florida, United States
University of Miami Pulmonary
Miami, Florida, United States
...and 34 more locations
Time frame: Day 28
Percentage of Participants With Adverse Events
Time frame: Up to Day 60