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

Primary Purpose

COVID-19 Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Tocilizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Hospitalized
  • COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
  • SpO2 < 94% while on ambient air

Inclusion Criteria Specific to Long-Term Extension

  • Participated in Study ML42528 (EMPACTA) (includes participants who completed or discontinued early from the main study)

Exclusion Criteria

  • Known severe allergic reactions to TCZ or other monoclonal antibodies
  • Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
  • 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
  • Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
  • Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
  • Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
  • Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory reference ranges)
  • Platelet count < 50,000/uL at screening (according to local laboratory reference ranges)
  • Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
  • Treatment with an investigational drug within 5 half lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medical Monitor)
  • 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
  • Any history of Diverticulitis or GI perforation
  • Use of systemic corticosteroids unless on a stable chronic dose

Sites / Locations

  • Banner - University Medical Center Phoenix; In-Patient Pharmacy
  • Univ of AZ Coll of Med
  • El Centro Regional Medical Center
  • eStudySite
  • Highland Hospital Oakland
  • St. Joseph'S Hospital
  • San Leandro Hospital; Inpatient Pharmacy
  • Larkin Community Hospital Palm Springs Campus (Hialeah)
  • Miami Veterans Administration Healthcare System - NAVREF
  • University of Miami Pulmonary
  • Larkin Community Hospital
  • St. Lukes Boise Medical Center
  • Ochsner Clinic
  • Holy Cross Germantown Hospital
  • Holy Cross Hospital
  • Henry Ford Health System
  • St. Joseph'S Regional Medical Center
  • San Juan Oncology Associates
  • St. Barnabas Hospital
  • SUNY Downstate Medical Center.
  • Elmhurst Hospital Center
  • Flushing Hospital
  • Jamaica Hospital Medical Center
  • Harlem Hospital
  • Canton-Potsdam Hospital
  • Novant Health Presbyterian Medical Center (Presbyterian Hospital)
  • Cape Fear Valley Medical Center
  • Temple University Hospital
  • Valley Baptist Medical Center
  • Michael E Debakey VA Medical Center
  • McAllen Medical Center
  • Sentara Medical Group
  • Hospital E Maternidade Celso Pierro PUCCAMP
  • Centro Multidisciplinar de Estudos Clínicos CEMEC FMABC
  • BR Trials - Pesquisa Clínica
  • Aga Khan University Hospital
  • Hospital General de Culiacan
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Hospital Militar Central
  • Hospital Nacional Sergio E. Bernales
  • Hospital Nacional Cayetano Heredia
  • Hospital Nacional Hipolito; Unanue
  • Hospital Maria Auxiliadora
  • George Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Tocilizumab

Arm Description

Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.

Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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: - 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) - Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen - Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen - ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen - ICU, requiring intubation and mechanical ventilation - ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support - Death
Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)
Mortality Rate by Day 28
Clinical Status on 7-Category Ordinal Scale at Day 28
Clinical status was assessed using a 7-category ordinal scale: - 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) - Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen - Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen - ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen - ICU, requiring intubation and mechanical ventilation - ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support - Death
Percentage of Participants With Adverse Events

Full Information

First Posted
April 29, 2020
Last Updated
February 8, 2023
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04372186
Brief Title
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Acronym
EMPACTA
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
August 18, 2020 (Actual)
Study Completion Date
September 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
Arm Title
Tocilizumab
Arm Type
Experimental
Arm Description
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
Description
Cumulative proportion is measured as a percentage of participants meeting the endpoint.
Time Frame
Up to Day 28
Secondary Outcome Measure Information:
Title
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
Title
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
Description
Clinical status was assessed using a 7-category ordinal scale: - 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) - Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen - Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen - ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen - ICU, requiring intubation and mechanical ventilation - ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support - Death
Time Frame
Up to Day 28
Title
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
Title
Mortality Rate by Day 28
Time Frame
Up to Day 28
Title
Clinical Status on 7-Category Ordinal Scale at Day 28
Description
Clinical status was assessed using a 7-category ordinal scale: - 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) - Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen - Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen - ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen - ICU, requiring intubation and mechanical ventilation - ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support - Death
Time Frame
Day 28
Title
Percentage of Participants With Adverse Events
Time Frame
Up to Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Hospitalized COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging SpO2 < 94% while on ambient air Inclusion Criteria Specific to Long-Term Extension Participated in Study ML42528 (EMPACTA) (includes participants who completed or discontinued early from the main study) Exclusion Criteria Known severe allergic reactions to TCZ or other monoclonal antibodies Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation 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 Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges) Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory reference ranges) Platelet count < 50,000/uL at screening (according to local laboratory reference ranges) Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination Treatment with an investigational drug within 5 half lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medical Monitor) 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 Any history of Diverticulitis or GI perforation Use of systemic corticosteroids unless on a stable chronic dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Banner - University Medical Center Phoenix; In-Patient Pharmacy
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Univ of AZ Coll of Med
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
El Centro Regional Medical Center
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Highland Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
St. Joseph'S Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
San Leandro Hospital; Inpatient Pharmacy
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Larkin Community Hospital Palm Springs Campus (Hialeah)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Miami Veterans Administration Healthcare System - NAVREF
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
University of Miami Pulmonary
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Larkin Community Hospital
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
St. Lukes Boise Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Holy Cross Germantown Hospital
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20876
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Joseph'S Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
St. Barnabas Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
SUNY Downstate Medical Center.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Flushing Hospital
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Harlem Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Canton-Potsdam Hospital
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Facility Name
Novant Health Presbyterian Medical Center (Presbyterian Hospital)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cape Fear Valley Medical Center
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Valley Baptist Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Michael E Debakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
McAllen Medical Center
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Sentara Medical Group
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Hospital E Maternidade Celso Pierro PUCCAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clínicos CEMEC FMABC
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
BR Trials - Pesquisa Clínica
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03325-050
Country
Brazil
Facility Name
Aga Khan University Hospital
City
Nairobi
ZIP/Postal Code
30270-00100
Country
Kenya
Facility Name
Hospital General de Culiacan
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
Country
Mexico
Facility Name
Hospital Militar Central
City
Jesus Maria
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
Hospital Nacional Sergio E. Bernales
City
Lima
ZIP/Postal Code
15003
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Hospital Nacional Hipolito; Unanue
City
Lima
ZIP/Postal Code
Lima 10
Country
Peru
Facility Name
Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Facility Name
George Provincial Hospital
City
George
ZIP/Postal Code
6259
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
33332779
Citation
Salama C, Han J, Yau L, Reiss WG, Kramer B, Neidhart JD, Criner GJ, Kaplan-Lewis E, Baden R, Pandit L, Cameron ML, Garcia-Diaz J, Chavez V, Mekebeb-Reuter M, Lima de Menezes F, Shah R, Gonzalez-Lara MF, Assman B, Freedman J, Mohan SV. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jan 7;384(1):20-30. doi: 10.1056/NEJMoa2030340. Epub 2020 Dec 17.
Results Reference
derived
PubMed Identifier
33201228
Citation
Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.
Results Reference
derived

Learn more about this trial

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

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