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

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ClinicalTrials.gov Identifier: NCT04372186
Recruitment Status : Active, not recruiting
First Posted : May 1, 2020
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19 Pneumonia
Interventions Drug: Placebo
Drug: Tocilizumab
Enrollment 377
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion. Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Period Title: Overall Study
Started 249 128
Completed 225 115
Not Completed 24 13
Reason Not Completed
Death             24             11
Transferred to a different facility for care             0             2
Arm/Group Title Tocilizumab Placebo Total
Hide Arm/Group Description Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion. Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion. Total of all reporting groups
Overall Number of Baseline Participants 249 128 377
Hide Baseline Analysis Population Description
mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization. Participants not receiving study treatment were excluded from analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 249 participants 128 participants 377 participants
56.0  (14.3) 55.6  (14.9) 55.9  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 128 participants 377 participants
Female
99
  39.8%
55
  43.0%
154
  40.8%
Male
150
  60.2%
73
  57.0%
223
  59.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 128 participants 377 participants
Hispanic or Latino
143
  57.4%
68
  53.1%
211
  56.0%
Not Hispanic or Latino
106
  42.6%
60
  46.9%
166
  44.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 128 participants 377 participants
American Indian or Alaska Native
52
  20.9%
25
  19.5%
77
  20.4%
Asian
5
   2.0%
1
   0.8%
6
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.8%
1
   0.3%
Black or African American
35
  14.1%
22
  17.2%
57
  15.1%
White
134
  53.8%
65
  50.8%
199
  52.8%
More than one race
4
   1.6%
2
   1.6%
6
   1.6%
Unknown or Not Reported
19
   7.6%
12
   9.4%
31
   8.2%
1.Primary Outcome
Title Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
Hide Description Cumulative proportion is measured as a percentage of participants meeting the endpoint.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 249 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
12.04
(8.52 to 16.86)
19.26
(13.34 to 27.36)
2.Secondary Outcome
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)
Hide Description [Not Specified]
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization. Participants not receiving study treatment were excluded from analyses.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 249 128
Median (95% Confidence Interval)
Unit of Measure: Days
6.0
(6.0 to 7.0)
7.5
(7.0 to 9.0)
3.Secondary Outcome
Title Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 249 128
Median (95% Confidence Interval)
Unit of Measure: Days
6.0
(6.0 to 7.0)
7.0
(6.0 to 9.0)
4.Secondary Outcome
Title Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)
Hide Description [Not Specified]
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 249 128
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Value is NA due to an insufficient number of participants with the event.
5.Secondary Outcome
Title Mortality Rate by Day 28
Hide Description [Not Specified]
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 249 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
10.4
(7.2 to 14.9)
8.6
(4.9 to 14.7)
6.Secondary Outcome
Title Clinical Status on 7-Category Ordinal Scale at Day 28
Hide Description

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 Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 249 128
Measure Type: Number
Unit of Measure: Percentage of participants
1 85.9 82.8
2 0.4 1.6
3 2.0 0.8
4 0.4 0.8
5 0.8 3.9
6 0 1.6
7 10.4 8.6
7.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame Up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety evaluable population = all participants who received any amount of study drug, grouped according to the treatment first received rather than by the treatment assigned at randomization.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
Overall Number of Participants Analyzed 250 127
Measure Type: Number
Unit of Measure: Percentage of participants
50.8 52.8
Time Frame Up to Day 60
Adverse Event Reporting Description The safety evaluable population included all participants who received any amount of study drug, grouped according to the treatment first received rather than by the treatment assigned at randomization.
 
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion. Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
All-Cause Mortality
Tocilizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   29/250 (11.60%)      15/127 (11.81%)    
Hide Serious Adverse Events
Tocilizumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/250 (15.20%)      25/127 (19.69%)    
Blood and lymphatic system disorders     
Anaemia of chronic disease * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Blood loss anaemia * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Disseminated intravascular coagulation * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Thrombocytopenia * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Acute myocardial infarction * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Atrial fibrillation * 1  1/250 (0.40%)  1 1/127 (0.79%)  1
Cardiac arrest * 1  2/250 (0.80%)  2 1/127 (0.79%)  1
Cardiac failure * 1  1/250 (0.40%)  1 1/127 (0.79%)  1
Cardio-respiratory arrest * 1  2/250 (0.80%)  2 0/127 (0.00%)  0
Myocardial infarction * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Gastrointestinal disorders     
Gastric ulcer * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Gastric varices * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Intestinal perforation * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Mesenteric haematoma * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Upper gastrointestinal haemorrhage * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
General disorders     
Multiple organ dysfunction syndrome * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Hepatobiliary disorders     
Gallbladder rupture * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Hepatic failure * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Infections and infestations     
Bacteraemia * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
COVID-19 * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
COVID-19 pneumonia * 1  2/250 (0.80%)  2 3/127 (2.36%)  3
Cellulitis * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Cellulitis of male external genital organ * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Cholecystitis infective * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Device related infection * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Pneumonia * 1  0/250 (0.00%)  0 3/127 (2.36%)  3
Pneumonia bacterial * 1  0/250 (0.00%)  0 2/127 (1.57%)  2
Pneumonia pseudomonal * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Pneumonia staphylococcal * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Sepsis * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Septic shock * 1  5/250 (2.00%)  5 3/127 (2.36%)  3
Investigations     
Transaminases increased * 1  2/250 (0.80%)  2 0/127 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Fluid overload * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Hypovolaemia * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Metabolic acidosis * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Nervous system disorders     
Brain injury * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Brain stem stroke * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Cerebral infarction * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Cerebrovascular accident * 1  2/250 (0.80%)  2 1/127 (0.79%)  1
Embolic stroke * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Ischaemic cerebral infarction * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Renal and urinary disorders     
Acute kidney injury * 1  1/250 (0.40%)  1 3/127 (2.36%)  3
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Acute respiratory distress syndrome * 1  5/250 (2.00%)  5 1/127 (0.79%)  1
Acute respiratory failure * 1  4/250 (1.60%)  4 3/127 (2.36%)  3
Pulmonary embolism * 1  3/250 (1.20%)  3 1/127 (0.79%)  1
Respiratory acidosis * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Respiratory distress * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
Respiratory failure * 1  4/250 (1.60%)  4 2/127 (1.57%)  2
Skin and subcutaneous tissue disorders     
Stasis dermatitis * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Vascular disorders     
Deep vein thrombosis * 1  1/250 (0.40%)  1 0/127 (0.00%)  0
Hypotension * 1  0/250 (0.00%)  0 1/127 (0.79%)  1
1
Term from vocabulary, MedDRA v23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tocilizumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/250 (11.20%)      8/127 (6.30%)    
Gastrointestinal disorders     
Constipation * 1  16/250 (6.40%)  16 4/127 (3.15%)  4
Psychiatric disorders     
Anxiety * 1  15/250 (6.00%)  15 4/127 (3.15%)  4
1
Term from vocabulary, MedDRA v23.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
EMail: genetech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04372186    
Other Study ID Numbers: ML42528
First Submitted: April 29, 2020
First Posted: May 1, 2020
Results First Submitted: August 4, 2021
Results First Posted: September 27, 2021
Last Update Posted: September 27, 2021