A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

Phase 3

Completed

Conditions: COVID-19 Pneumonia

Interventions: Drug: Placebo
Drug: Tocilizumab

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

Inclusion Criteria

Not provided

Exclusion Criteria

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. - Death
Time 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. - Death
Percentage of Participants With Adverse Events	Up to Day 60

Trial Locations

Locations (44): 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
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Banner - University Medical Center Phoenix; In-Patient Pharmacy
🇺🇸Phoenix, Arizona, United States