A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
- Registration Number
- NCT04372186
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 377
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given. Tocilizumab Tocilizumab Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
- Primary Outcome Measures
Name Time Method Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 Up to Day 28 Cumulative proportion is measured as a percentage of participants meeting the endpoint.
- Secondary Outcome Measures
Name Time Method 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) Up to Day 28 Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First) Up to Day 28 Mortality Rate by Day 28 Up to Day 28 Clinical Status on 7-Category Ordinal Scale at Day 28 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. - DeathTime to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status Up to 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. - DeathPercentage of Participants With Adverse Events Up to Day 60
Trial Locations
- Locations (44)
eStudySite
🇺🇸La Mesa, California, United States
El Centro Regional Medical Center
🇺🇸El Centro, California, United States
Highland Hospital Oakland
🇺🇸Oakland, California, United States
St. Joseph'S Hospital
🇺🇸Orange, California, United States
Larkin Community Hospital
🇺🇸South Miami, Florida, United States
Holy Cross Germantown Hospital
🇺🇸Germantown, Maryland, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
SUNY Downstate Medical Center.
🇺🇸Brooklyn, New York, United States
Flushing Hospital
🇺🇸Flushing, New York, United States
Harlem Hospital
🇺🇸New York, New York, United States
Canton-Potsdam Hospital
🇺🇸Potsdam, New York, United States
Cape Fear Valley Medical Center
🇺🇸Fayetteville, North Carolina, United States
Novant Health Presbyterian Medical Center (Presbyterian Hospital)
🇺🇸Charlotte, North Carolina, United States
Valley Baptist Medical Center
🇺🇸Harlingen, Texas, United States
McAllen Medical Center
🇺🇸McAllen, Texas, United States
Centro Multidisciplinar de Estudos ClÃnicos CEMEC FMABC
🇧🇷Sao Bernardo Do Campo, SP, Brazil
Hospital E Maternidade Celso Pierro PUCCAMP
🇧🇷Campinas, SP, Brazil
BR Trials - Pesquisa ClÃnica
🇧🇷Sao Paulo, SP, Brazil
Aga Khan University Hospital
🇰🇪Nairobi, Kenya
Hospital General de Culiacan
🇲🇽Culiacan, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico, Mexico
Hospital Nacional Sergio E. Bernales
🇵🇪Lima, Peru
Hospital Nacional Cayetano Heredia
🇵🇪Lima, Peru
Hospital Nacional Hipolito; Unanue
🇵🇪Lima, Peru
Hospital Maria Auxiliadora
🇵🇪Lima, Peru
George Provincial Hospital
🇿🇦George, South Africa
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
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Michael E Debakey VA Medical Center
🇺🇸Houston, Texas, United States
Sentara Medical Group
🇺🇸Virginia Beach, Virginia, United States
Univ of AZ Coll of Med
🇺🇸Tucson, Arizona, United States
St. Lukes Boise Medical Center
🇺🇸Boise, Idaho, United States
St. Joseph'S Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Banner - University Medical Center Phoenix; In-Patient Pharmacy
🇺🇸Phoenix, Arizona, United States
San Leandro Hospital; Inpatient Pharmacy
🇺🇸San Leandro, California, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
St. Barnabas Hospital
🇺🇸Bronx, New York, United States
Hospital Militar Central
🇵🇪Jesus Maria, Peru