Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372186
Recruitment Status : Active, not recruiting
First Posted : May 1, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 29, 2020
First Posted Date  ICMJE May 1, 2020
Last Update Posted Date July 15, 2021
Actual Study Start Date  ICMJE May 14, 2020
Actual Primary Completion Date August 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
Cumulative Proportion of Participants Requiring Mechanical Ventilation by Day 28 [ Time Frame: Up to Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to Day 28 ]
  • Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) [ Time Frame: Up to Day 28 ]
  • Mortality Rate by Day 28 [ 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 ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to Day 60 ]
  • Percentage of Participants with any Post-Treatment Bacterial and/or Fungal Infection [ Time Frame: Up to Day 60 ]
  • Incidence of Post-Treatment Acute Kidney injury (defined by 50% increase of creatinine from baseline) [ Time Frame: Up to Day 60 ]
  • Quality of Life (QoL) as Reported by the Short Form 36 Question Health Survey Version 2 (SF-36v2) [ Time Frame: 12 months ]
  • QoL as Reported by the Euro-QoL-5D-5-L (EQ-5D-5L) Instrument [ Time Frame: 12 months ]
  • QoL as Reported by Living with Idiopathic Pulmonary Fibrosis Symptoms Questionnaire-Modified (L-IPF-M) [ Time Frame: 12 months ]
  • QoL as Reported by the Montreal Cognitive Assessment (MoCA) [ Time Frame: 12 months ]
  • Lung Texture as Measured by High-Resolution Computed Tomography (HRCT) Scan of Chest [ Time Frame: 12 months ]
  • Prevalence and Incidence of COVID-19 Antibodies [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to Day 28 ]
  • Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) [ Time Frame: Up to Day 28 ]
  • Mortality Rate by Day 28 [ 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 ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to Day 60 ]
  • Percentage of Participants with any Post-Treatment Bacterial and/or Fungal Infection [ Time Frame: Up to Day 60 ]
  • Incidence of Post-Treatment Acute Kidney injury (defined by 50% increase of creatinine from baseline) [ Time Frame: Up to Day 60 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE
  • Drug: Placebo
    Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
  • Drug: Tocilizumab
    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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
    Intervention: Drug: Placebo
  • Experimental: Tocilizumab
    Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
    Intervention: Drug: Tocilizumab
  • No Intervention: Optional Long-Term Extension
    Participants at selected sites will be followed up for approximately 12 months after hospital discharge or the end of the main study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 13, 2021)
388
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
379
Estimated Study Completion Date  ICMJE December 1, 2021
Actual Primary Completion Date August 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Kenya,   Mexico,   Peru,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04372186
Other Study ID Numbers  ICMJE ML42528
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP