Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia (NCT NCT04372186)
NCT ID: NCT04372186
Last Updated: 2023-02-10
Results Overview
Cumulative proportion is measured as a percentage of participants meeting the endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
377 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
Tocilizumab
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
128
|
|
Overall Study
COMPLETED
|
225
|
115
|
|
Overall Study
NOT COMPLETED
|
24
|
13
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Overall Study
Death
|
24
|
11
|
|
Overall Study
Transferred to a different facility for care
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
55.6 Years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
55.9 Years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
143 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
52 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
Cumulative proportion is measured as a percentage of participants meeting the endpoint.
Outcome measures
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
|
12.04 Percentage of Participants
Interval 8.52 to 16.86
|
19.26 Percentage of Participants
Interval 13.34 to 27.36
|
SECONDARY outcome
Timeframe: Up to Day 28Population: 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.
Outcome measures
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
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)
|
6.0 Days
Interval 6.0 to 7.0
|
7.5 Days
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
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
Outcome measures
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
|
6.0 Days
Interval 6.0 to 7.0
|
7.0 Days
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
Outcome measures
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)
|
NA Days
Value is NA due to an insufficient number of participants with the event.
|
NA Days
Value is NA due to an insufficient number of participants with the event.
|
SECONDARY outcome
Timeframe: Up to Day 28Outcome measures
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Mortality Rate by Day 28
|
10.4 Percentage of Participants
Interval 7.2 to 14.9
|
8.6 Percentage of Participants
Interval 4.9 to 14.7
|
SECONDARY outcome
Timeframe: Day 28Population: mITT population = all randomized participants who received study treatment, grouped according to the treatment assigned at randomization.
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
Outcome measures
| Measure |
Tocilizumab
n=249 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=128 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
1
|
85.9 Percentage of participants
|
82.8 Percentage of participants
|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
2
|
0.4 Percentage of participants
|
1.6 Percentage of participants
|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
3
|
2.0 Percentage of participants
|
0.8 Percentage of participants
|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
4
|
0.4 Percentage of participants
|
0.8 Percentage of participants
|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
5
|
0.8 Percentage of participants
|
3.9 Percentage of participants
|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
6
|
0 Percentage of participants
|
1.6 Percentage of participants
|
|
Clinical Status on 7-Category Ordinal Scale at Day 28
7
|
10.4 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 60Population: 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.
Outcome measures
| Measure |
Tocilizumab
n=250 Participants
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=127 Participants
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
50.8 Percentage of participants
|
52.8 Percentage of participants
|
Adverse Events
Tocilizumab
Serious events: 38 serious events
Other events: 28 other events
Deaths: 29 deaths
Placebo
Serious events: 25 serious events
Other events: 8 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Tocilizumab
n=250 participants at risk
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=127 participants at risk
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Cardiac disorders
Cardiac arrest
|
0.80%
2/250 • Number of events 2 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Cardiac disorders
Cardiac failure
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.80%
2/250 • Number of events 2 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Gastrointestinal disorders
Gastric varices
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Gastrointestinal disorders
Mesenteric haematoma
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Bacteraemia
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
COVID-19
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.80%
2/250 • Number of events 2 • Up to Day 60
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.
|
2.4%
3/127 • Number of events 3 • Up to Day 60
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.
|
|
Infections and infestations
Cellulitis
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Cholecystitis infective
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Device related infection
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/250 • Up to Day 60
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.
|
2.4%
3/127 • Number of events 3 • Up to Day 60
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.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/250 • Up to Day 60
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.
|
1.6%
2/127 • Number of events 2 • Up to Day 60
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.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Sepsis
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Infections and infestations
Septic shock
|
2.0%
5/250 • Number of events 5 • Up to Day 60
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.
|
2.4%
3/127 • Number of events 3 • Up to Day 60
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.
|
|
Investigations
Transaminases increased
|
0.80%
2/250 • Number of events 2 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Nervous system disorders
Brain injury
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Nervous system disorders
Brain stem stroke
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Nervous system disorders
Cerebral infarction
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.80%
2/250 • Number of events 2 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
2.4%
3/127 • Number of events 3 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.0%
5/250 • Number of events 5 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.6%
4/250 • Number of events 4 • Up to Day 60
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.
|
2.4%
3/127 • Number of events 3 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
3/250 • Number of events 3 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
4/250 • Number of events 4 • Up to Day 60
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.
|
1.6%
2/127 • Number of events 2 • Up to Day 60
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.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
1/250 • Number of events 1 • Up to Day 60
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.
|
0.00%
0/127 • Up to Day 60
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/250 • Up to Day 60
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.
|
0.79%
1/127 • Number of events 1 • Up to Day 60
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.
|
Other adverse events
| Measure |
Tocilizumab
n=250 participants at risk
Participants received one IV infusion of TCZ in addition to SOC with up to one additional infusion.
|
Placebo
n=127 participants at risk
Participants received one intravenous (IV) infusion of placebo, in addition to SOC, with up to one additional infusion.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.4%
16/250 • Number of events 16 • Up to Day 60
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.
|
3.1%
4/127 • Number of events 4 • Up to Day 60
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.
|
|
Psychiatric disorders
Anxiety
|
6.0%
15/250 • Number of events 15 • Up to Day 60
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.
|
3.1%
4/127 • Number of events 4 • Up to Day 60
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER