Trial Outcomes & Findings for Treatment of COVID-19 Patients With Anti-interleukin Drugs (NCT NCT04330638)
NCT ID: NCT04330638
Last Updated: 2023-03-14
Results Overview
Time to Clinical Improvement is defined as the time from randomization to either an increase of at least two points on a six category ordinal scale from the status at randomization or live discharge from the hospital.The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
342 participants
Primary outcome timeframe
at day 15
Results posted on
2023-03-14
Participant Flow
Between April 4th and December 6th, 2020, 342 patients were randomized. In the first randomization, 230 patients were assigned to the no IL-1 blockade group and 112 to the IL-1 blockade group, of which all received at least one dose of anakinra. In the second randomization, 115 patients were assigned to the no IL-6 blockade group, and 227 to the IL-6 blockade group, of which 114 were allocated to receive tocilizumab and 113 siltuximab.
111 received siltuximab at day 1, 2 received no siltuximab due to withdrawal of consent. 113 received tocilizumab at day 1, 1 was not administered for unknown reason.
Participant milestones
| Measure |
Usual Care
Usual Care: Usual Care
|
Anakinra: IL1-blocker
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
|
Siltuximab: IL-6 Blocker
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Anakinra + Siltuximab
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Tocilizumab: IL-6 Blocker
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
Anakinra + Tocilizumab
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
44
|
75
|
36
|
81
|
32
|
|
Overall Study
Randomization 1: No IL-1 Blockade
|
74
|
0
|
75
|
0
|
81
|
0
|
|
Overall Study
Randomization 1: IL-1 Blockade
|
0
|
44
|
0
|
36
|
0
|
32
|
|
Overall Study
Randomization 2: No IL-6 Blockade
|
74
|
41
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomization 2: IL-6 Blockade
|
0
|
0
|
75
|
36
|
81
|
32
|
|
Overall Study
COMPLETED
|
56
|
30
|
52
|
27
|
65
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
23
|
9
|
16
|
7
|
Reasons for withdrawal
| Measure |
Usual Care
Usual Care: Usual Care
|
Anakinra: IL1-blocker
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
|
Siltuximab: IL-6 Blocker
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Anakinra + Siltuximab
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Tocilizumab: IL-6 Blocker
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
Anakinra + Tocilizumab
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
10
|
15
|
6
|
10
|
5
|
|
Overall Study
Other
|
2
|
2
|
5
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
3
|
2
|
3
|
0
|
Baseline Characteristics
112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
Baseline characteristics by cohort
| Measure |
Blockade
n=339 Participants
Patients receiving Anakinra, patients receiving Siltuximab, patients receiving Tocilizumab, patients receiving Anakinra and Siltuximab, patients receiving Anakinra and Tocilizumab
|
No Blockade
n=345 Participants
Participants receiving no IL1 blockade + participants receiving no IL6 blockade
|
Total
n=684 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
IL-1
|
67 years
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
64 years
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
65 years
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Age, Continuous
IL-6
|
65 years
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
64 years
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
65 years
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Sex/Gender, Customized
IL-1: Female
|
25 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
52 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
77 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Sex/Gender, Customized
IL-1: Male
|
87 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
178 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
265 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Sex/Gender, Customized
IL-6: Female
|
52 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
25 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
77 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Sex/Gender, Customized
IL-6: Male
|
175 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
90 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
265 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-1 : white
|
98 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
180 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
278 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-1: Middle Eastern-Arabian
|
11 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
29 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
40 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-1:Black
|
1 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
8 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
9 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-1: Asian
|
1 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
6 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
7 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-1 : Other
|
1 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
7 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
8 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-6 : white
|
184 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
94 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
278 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-6 : Middle Eastern-Arabian
|
27 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
13 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
40 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-6: Black
|
8 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
1 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
9 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-6: Asian
|
4 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
3 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
7 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Race/Ethnicity, Customized
IL-6: Other
|
4 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
4 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
8 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Body Mass Index (BMI)
IL-1
|
28 kg/m^2
n=108 Participants • BMI was available for 108 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 222 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
28 kg/m^2
n=222 Participants • BMI was available for 108 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 222 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
28 kg/m^2
n=330 Participants • BMI was available for 108 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 222 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
|
Body Mass Index (BMI)
IL-6
|
28 kg/m^2
n=222 Participants • BMI was available for 108 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 222 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
28 kg/m^2
n=108 Participants • BMI was available for 108 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 222 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
28 kg/m^2
n=330 Participants • BMI was available for 108 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 222 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
|
Smoking
IL-1:No
|
54 Participants
n=95 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
108 Participants
n=186 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
162 Participants
n=281 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
|
Smoking
IL-1: Current
|
7 Participants
n=95 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
11 Participants
n=186 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
18 Participants
n=281 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
|
Smoking
IL-1: Former
|
34 Participants
n=95 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
67 Participants
n=186 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
101 Participants
n=281 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-6: Antibiotics
|
103 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
55 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
158 Participants
n=345 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Smoking
IL-6: No
|
101 Participants
n=181 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
61 Participants
n=100 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
162 Participants
n=281 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
|
Smoking
IL-6: Current
|
15 Participants
n=181 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
3 Participants
n=100 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
18 Participants
n=281 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
|
Smoking
IL-6: Former
|
65 Participants
n=181 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
36 Participants
n=100 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
101 Participants
n=281 Participants • Smoking status was available for 95 of 112 participants that received the IL-1 Blockade, 181 of 227 participants that received the IL-6 Blockade, 186 of 230 participants that received no IL-1 blockade, and for 100 of 115 participants that received no IL-6 blockade
|
|
Co-existing conditions
IL-1: Arterial hypertension
|
57 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
104 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
161 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-1 Diabetes mellitus
|
37 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
58 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
95 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-1: Cardiovascular disease
|
29 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
41 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
70 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-1: Chronic kidney disease
|
14 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
23 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
37 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-6: Arterial hypertension
|
115 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
46 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
161 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-6 Diabetes mellitus
|
59 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
36 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
95 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-6: Cardiovascular disease
|
46 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
24 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
70 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Co-existing conditions
IL-6: Chronic kidney disease
|
25 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
12 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
37 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-1: Hospitalized, on invasive mechanical ventilation (2)
|
14 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
22 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
36 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-1: Hospitalized, on non-invasive ventilation or high flow oxygen devices (3)
|
44 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
84 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
128 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-1: Hospitalized, requiring supplemental oxygen (4)
|
50 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
119 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
169 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-1: Hospitalized, not requiring supplemental oxygen (5)
|
1 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
5 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
6 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-6: Hospitalized, on invasive mechanical ventilation (2)
|
22 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
17 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
39 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-6: Hospitalized, on non-invasive ventilation or high flow oxygen devices (3)
|
89 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
39 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
128 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-6: Hospitalized, requiring supplemental oxygen (4)
|
111 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
58 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
169 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
6-category ordinal scale for clinical improvement at day of randomization
IL-6: Hospitalized, not requiring supplemental oxygen (5)
|
5 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
1 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
6 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
ICU at day of randomization
IL-1
|
60 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
112 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
172 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
ICU at day of randomization
IL-6
|
113 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
59 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
172 Participants
n=342 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
SOFA score at day of randomization
IL-1
|
3 units on a scale
n=109 Participants • SOFA score was available for 109 of 112 participants that received the IL-1 Blockade , for 208 of 227 that received the IL-6 Blockade, for 207 of 230 that received no IL-1 blockade, and for 108 of 115 that received no IL-6 blockade
|
3 units on a scale
n=207 Participants • SOFA score was available for 109 of 112 participants that received the IL-1 Blockade , for 208 of 227 that received the IL-6 Blockade, for 207 of 230 that received no IL-1 blockade, and for 108 of 115 that received no IL-6 blockade
|
3 units on a scale
n=316 Participants • SOFA score was available for 109 of 112 participants that received the IL-1 Blockade , for 208 of 227 that received the IL-6 Blockade, for 207 of 230 that received no IL-1 blockade, and for 108 of 115 that received no IL-6 blockade
|
|
SOFA score at day of randomization
IL-6
|
3 units on a scale
n=208 Participants • SOFA score was available for 109 of 112 participants that received the IL-1 Blockade , for 208 of 227 that received the IL-6 Blockade, for 207 of 230 that received no IL-1 blockade, and for 108 of 115 that received no IL-6 blockade
|
3 units on a scale
n=108 Participants • SOFA score was available for 109 of 112 participants that received the IL-1 Blockade , for 208 of 227 that received the IL-6 Blockade, for 207 of 230 that received no IL-1 blockade, and for 108 of 115 that received no IL-6 blockade
|
3 units on a scale
n=316 Participants • SOFA score was available for 109 of 112 participants that received the IL-1 Blockade , for 208 of 227 that received the IL-6 Blockade, for 207 of 230 that received no IL-1 blockade, and for 108 of 115 that received no IL-6 blockade
|
|
PaO2/FiO2 ratio at day of randomization
IL-1
|
135 ratio
n=99 Participants • PaO2/FiO2 was available for 99 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 228 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
154 ratio
n=228 Participants • PaO2/FiO2 was available for 99 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 228 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
150 ratio
n=327 Participants • PaO2/FiO2 was available for 99 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 228 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
|
PaO2/FiO2 ratio at day of randomization
IL-6
|
155 ratio
n=216 Participants • PaO2/FiO2 was available for 99 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 228 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
144 ratio
n=111 Participants • PaO2/FiO2 was available for 99 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 228 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
150 ratio
n=327 Participants • PaO2/FiO2 was available for 99 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 228 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
|
Vasopressor use at day of randomization
IL-1
|
10 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
11 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
21 Participants
n=339 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Vasopressor use at day of randomization
IL-6
|
12 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
9 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
21 Participants
n=345 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Days of symptoms at randomization
IL-1
|
10 days
n=100 Participants • Days of symptoms at randomization was available for 100 of 112 participants that received the IL-1 Blockade, for 214 of 227 participants that received the IL-6 Blockade, for 207 of 230 participants that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
10 days
n=207 Participants • Days of symptoms at randomization was available for 100 of 112 participants that received the IL-1 Blockade, for 214 of 227 participants that received the IL-6 Blockade, for 207 of 230 participants that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
10 days
n=307 Participants • Days of symptoms at randomization was available for 100 of 112 participants that received the IL-1 Blockade, for 214 of 227 participants that received the IL-6 Blockade, for 207 of 230 participants that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
|
Days of symptoms at randomization
IL-6
|
10 days
n=214 Participants • Days of symptoms at randomization was available for 100 of 112 participants that received the IL-1 Blockade, for 214 of 227 participants that received the IL-6 Blockade, for 207 of 230 participants that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
10 days
n=107 Participants • Days of symptoms at randomization was available for 100 of 112 participants that received the IL-1 Blockade, for 214 of 227 participants that received the IL-6 Blockade, for 207 of 230 participants that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
10 days
n=321 Participants • Days of symptoms at randomization was available for 100 of 112 participants that received the IL-1 Blockade, for 214 of 227 participants that received the IL-6 Blockade, for 207 of 230 participants that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
|
days of hospitalization at randomization
IL-1
|
3 days
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
2 days
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
2 days
n=339 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
days of hospitalization at randomization
IL-6
|
3 days
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
2 days
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
2 days
n=345 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-1: Antibiotics
|
58 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
100 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
158 Participants
n=339 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-1: Remdesivir
|
6 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
11 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
17 Participants
n=339 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-1: Hydroxychloroquine
|
18 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
22 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
40 Participants
n=339 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-1: Glucocorticoids
|
72 Participants
n=112 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
141 Participants
n=227 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
213 Participants
n=339 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-6: Remdesivir
|
11 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
6 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
17 Participants
n=345 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-6: Hydroxychloroquine
|
25 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
15 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
40 Participants
n=345 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
Concommitant medication at day of randomization
IL-6: Glucocorticoids
|
141 Participants
n=230 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
72 Participants
n=115 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
213 Participants
n=345 Participants • 112 participants received the IL-1 Blockade, 227 received the IL-6 Blockade, 230 received no IL-1 blockade, and 115 received no IL-6 blockade
|
|
CRP at day of randomization
IL-1
|
148 mg/mL
n=112 Participants • CRP was available for all 112 participants that received the IL-1 Blockade, for 226 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 114 of 115 participants that received no IL-6 blockade
|
123 mg/mL
n=224 Participants • CRP was available for all 112 participants that received the IL-1 Blockade, for 226 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 114 of 115 participants that received no IL-6 blockade
|
129 mg/mL
n=336 Participants • CRP was available for all 112 participants that received the IL-1 Blockade, for 226 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 114 of 115 participants that received no IL-6 blockade
|
|
CRP at day of randomization
IL-6
|
129 mg/mL
n=226 Participants • CRP was available for all 112 participants that received the IL-1 Blockade, for 226 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 114 of 115 participants that received no IL-6 blockade
|
129 mg/mL
n=114 Participants • CRP was available for all 112 participants that received the IL-1 Blockade, for 226 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 114 of 115 participants that received no IL-6 blockade
|
129 mg/mL
n=340 Participants • CRP was available for all 112 participants that received the IL-1 Blockade, for 226 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 114 of 115 participants that received no IL-6 blockade
|
|
Lymphocyte count at day of randomization
IL-1
|
0.7 10^3 cells /µL
n=108 Participants • Lymphocyte count at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 220 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 112 of 115 participants that received no IL-6 blockade
|
0.7 10^3 cells /µL
n=224 Participants • Lymphocyte count at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 220 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 112 of 115 participants that received no IL-6 blockade
|
0.7 10^3 cells /µL
n=332 Participants • Lymphocyte count at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 220 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 112 of 115 participants that received no IL-6 blockade
|
|
Lymphocyte count at day of randomization
IL-6
|
0.6 10^3 cells /µL
n=220 Participants • Lymphocyte count at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 220 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 112 of 115 participants that received no IL-6 blockade
|
0.7 10^3 cells /µL
n=112 Participants • Lymphocyte count at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 220 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 112 of 115 participants that received no IL-6 blockade
|
0.7 10^3 cells /µL
n=332 Participants • Lymphocyte count at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 220 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 112 of 115 participants that received no IL-6 blockade
|
|
Ferritin at day of randomization
IL-1
|
1672 µg/L
n=109 Participants • Ferritin at day of randomization was available for 109 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 223 of 230 that received no IL-1 blockade, and for 110 of 115 participants that received no IL-6 blockade
|
1688 µg/L
n=223 Participants • Ferritin at day of randomization was available for 109 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 223 of 230 that received no IL-1 blockade, and for 110 of 115 participants that received no IL-6 blockade
|
1687 µg/L
n=332 Participants • Ferritin at day of randomization was available for 109 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 223 of 230 that received no IL-1 blockade, and for 110 of 115 participants that received no IL-6 blockade
|
|
Ferritin at day of randomization
IL-6
|
1680 µg/L
n=222 Participants • Ferritin at day of randomization was available for 109 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 223 of 230 that received no IL-1 blockade, and for 110 of 115 participants that received no IL-6 blockade
|
1749 µg/L
n=110 Participants • Ferritin at day of randomization was available for 109 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 223 of 230 that received no IL-1 blockade, and for 110 of 115 participants that received no IL-6 blockade
|
1687 µg/L
n=332 Participants • Ferritin at day of randomization was available for 109 of 112 participants that received the IL-1 Blockade, for 222 of 227 participants that received the IL-6 Blockade, for 223 of 230 that received no IL-1 blockade, and for 110 of 115 participants that received no IL-6 blockade
|
|
D-dimers at day of randomization
IL-1
|
1091 ng/mL
n=90 Participants • D-dimers at day of randomization was available for 90 of 112 participants that received the IL-1 Blockade, for 192 of 227 participants that received the IL-6 Blockade, for 193 of 230 that received no IL-1 blockade, and for 91 of 115 participants that received no IL-6 blockade
|
1000 ng/mL
n=193 Participants • D-dimers at day of randomization was available for 90 of 112 participants that received the IL-1 Blockade, for 192 of 227 participants that received the IL-6 Blockade, for 193 of 230 that received no IL-1 blockade, and for 91 of 115 participants that received no IL-6 blockade
|
1011 ng/mL
n=283 Participants • D-dimers at day of randomization was available for 90 of 112 participants that received the IL-1 Blockade, for 192 of 227 participants that received the IL-6 Blockade, for 193 of 230 that received no IL-1 blockade, and for 91 of 115 participants that received no IL-6 blockade
|
|
D-dimers at day of randomization
IL-6
|
1000 ng/mL
n=192 Participants • D-dimers at day of randomization was available for 90 of 112 participants that received the IL-1 Blockade, for 192 of 227 participants that received the IL-6 Blockade, for 193 of 230 that received no IL-1 blockade, and for 91 of 115 participants that received no IL-6 blockade
|
1099 ng/mL
n=91 Participants • D-dimers at day of randomization was available for 90 of 112 participants that received the IL-1 Blockade, for 192 of 227 participants that received the IL-6 Blockade, for 193 of 230 that received no IL-1 blockade, and for 91 of 115 participants that received no IL-6 blockade
|
1011 ng/mL
n=283 Participants • D-dimers at day of randomization was available for 90 of 112 participants that received the IL-1 Blockade, for 192 of 227 participants that received the IL-6 Blockade, for 193 of 230 that received no IL-1 blockade, and for 91 of 115 participants that received no IL-6 blockade
|
|
LDH at day of randomization
IL-1
|
445 IU/L
n=111 Participants • LDH was available for 111 of 112 participants that received the IL-1 Blockade, for 224 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
430 IU/L
n=224 Participants • LDH was available for 111 of 112 participants that received the IL-1 Blockade, for 224 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
435 IU/L
n=335 Participants • LDH was available for 111 of 112 participants that received the IL-1 Blockade, for 224 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
|
LDH at day of randomization
IL-6
|
435 IU/L
n=224 Participants • LDH was available for 111 of 112 participants that received the IL-1 Blockade, for 224 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
435 IU/L
n=111 Participants • LDH was available for 111 of 112 participants that received the IL-1 Blockade, for 224 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
435 IU/L
n=335 Participants • LDH was available for 111 of 112 participants that received the IL-1 Blockade, for 224 of 227 participants that received the IL-6 Blockade, for 224 of 230 that received no IL-1 blockade, and for 111 of 115 participants that received no IL-6 blockade
|
|
IL-1-RA at day of randomization
IL-1
|
940 ng/mL
n=108 Participants • IL-1-RA at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
903 ng/mL
n=216 Participants • IL-1-RA at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
916 ng/mL
n=324 Participants • IL-1-RA at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
|
IL-1-RA at day of randomization
IL-6
|
931 ng/mL
n=216 Participants • IL-1-RA at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
885 ng/mL
n=108 Participants • IL-1-RA at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
916 ng/mL
n=324 Participants • IL-1-RA at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
|
IL-1B at day of randomization
IL-1
|
44 fg/mL
n=104 Participants • IL-1B at day of randomization was available for 104 of 112 participants that received the IL-1 Blockade, for 213 of 227 participants that received the IL-6 Blockade, for 210 of 230 that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
60 fg/mL
n=213 Participants • IL-1B at day of randomization was available for 104 of 112 participants that received the IL-1 Blockade, for 213 of 227 participants that received the IL-6 Blockade, for 210 of 230 that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
56 fg/mL
n=317 Participants • IL-1B at day of randomization was available for 104 of 112 participants that received the IL-1 Blockade, for 213 of 227 participants that received the IL-6 Blockade, for 210 of 230 that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
|
IL-1B at day of randomization
IL-6
|
52 fg/mL
n=210 Participants • IL-1B at day of randomization was available for 104 of 112 participants that received the IL-1 Blockade, for 213 of 227 participants that received the IL-6 Blockade, for 210 of 230 that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
74 fg/mL
n=107 Participants • IL-1B at day of randomization was available for 104 of 112 participants that received the IL-1 Blockade, for 213 of 227 participants that received the IL-6 Blockade, for 210 of 230 that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
56 fg/mL
n=317 Participants • IL-1B at day of randomization was available for 104 of 112 participants that received the IL-1 Blockade, for 213 of 227 participants that received the IL-6 Blockade, for 210 of 230 that received no IL-1 blockade, and for 107 of 115 participants that received no IL-6 blockade
|
|
IL-6 at day of randomization
IL-1
|
8 pg/mL
n=108 Participants • IL-6 at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
10 pg/mL
n=216 Participants • IL-6 at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
9 pg/mL
n=324 Participants • IL-6 at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
|
IL-6 at day of randomization
IL-6
|
9 pg/mL
n=216 Participants • IL-6 at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
8 pg/mL
n=108 Participants • IL-6 at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
9 pg/mL
n=324 Participants • IL-6 at day of randomization was available for 108 of 112 participants that received the IL-1 Blockade, for 216 of 227 participants that received the IL-6 Blockade, for 216 of 230 that received no IL-1 blockade, and for 108 of 115 participants that received no IL-6 blockade
|
PRIMARY outcome
Timeframe: at day 15Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Time to Clinical Improvement is defined as the time from randomization to either an increase of at least two points on a six category ordinal scale from the status at randomization or live discharge from the hospital.The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Time to Clinical Improvement
|
12 days
Interval 10.0 to 16.0
|
12 days
Interval 10.0 to 15.0
|
11 days
Interval 10.0 to 16.0
|
12 days
Interval 11.0 to 16.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Time Untill Discharge
|
14 days
Interval 11.0 to 19.0
|
12 days
Interval 11.0 to 18.0
|
12 days
Interval 11.0 to 18.0
|
13 days
Interval 11.0 to 19.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Time Until Independence From Supplemental Oxygen or Discharge
|
12 days
Interval 10.0 to 20.0
|
12 days
Interval 10.0 to 15.0
|
11 days
Interval 10.0 to 15.0
|
12 days
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 54 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Time Until Independence From Invasive Ventilation
|
21 days
Interval 8.0 to
Upper limit of 95% CI not estimable due to insufficient numbers of participants who reached independence of invasive mechanical ventilation
|
27 days
Interval 9.0 to
Upper limit of 95% CI not estimable due to insufficient numbers of participants who reached independence of invasive mechanical ventilation
|
23 days
Interval 8.0 to
Upper limit of 95% CI not estimable due to insufficient numbers of participants who reached independence of invasive mechanical ventilation
|
54 days
Interval 9.0 to
Upper limit of 95% CI not estimable due to insufficient numbers of participants who reached independence of invasive mechanical ventilation
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Days in ICU
|
11 days
Interval 8.0 to 15.0
|
10 days
Interval 8.0 to 13.0
|
11 days
Interval 8.0 to 14.0
|
10 days
Interval 7.0 to 15.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Days in ICU in Patients Ventilated at Day of Randomization
|
20 days
Interval 15.0 to 27.0
|
22 days
Interval 17.0 to 29.0
|
20 days
Interval 16.0 to 27.0
|
22 days
Interval 16.0 to 29.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Days Without Supplemental Oxygen Use
|
9 days
Interval 7.0 to 12.0
|
9 days
Interval 7.0 to 11.0
|
10 days
Interval 8.0 to 12.0
|
8 days
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Invasive Ventilator Days
|
5 days
Interval 3.0 to 9.0
|
5 days
Interval 3.0 to 7.0
|
5 days
Interval 3.0 to 7.0
|
5 days
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Invasive Ventilator Days in Patients Ventilated at Day of Randomization
|
15 days
Interval 11.0 to 20.0
|
16 days
Interval 13.0 to 21.0
|
15 days
Interval 12.0 to 20.0
|
16 days
Interval 12.0 to 22.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Invasive Ventilator-free Days
|
18 days
Interval 15.0 to 21.0
|
18 days
Interval 16.0 to 20.0
|
18 days
Interval 17.0 to 20.0
|
17 days
Interval 15.0 to 20.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Number of Invasive Ventilator-free Days in Patients Ventilated at Day of Randomization
|
6 days
Interval 3.0 to 14.0
|
6 days
Interval 3.0 to 13.0
|
7 days
Interval 4.0 to 15.0
|
5 days
Interval 2.0 to 12.0
|
SECONDARY outcome
Timeframe: first 28 days after randomizationPopulation: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Number of days the participants were ventilated, relative to the number of days participants were alive during the first 28 days after randomization. This was calculated as the number of days with need for invasive ventilation / number of days alive during first 28 days, multiplied by 100 (to obtain a percentage).
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Percentage of Days in ICU
|
42 percentage of days
Interval 31.0 to 56.0
|
36 percentage of days
Interval 29.0 to 46.0
|
38 percentage of days
Interval 30.0 to 48.0
|
40 percentage of days
Interval 29.0 to 54.0
|
SECONDARY outcome
Timeframe: the first 28 days after randomizationPopulation: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Number of days the participant spent in the ICU, relative to the number of days the patient was alive during the first 28 days after randomization. This was calculated as the number of days in ICU during first 28 days / number of days alive during first 28 days, multiplied by 100 (to obtain a percentage).
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Percentage of Invasive Ventilator Days
|
23 percentage of days
Interval 14.0 to 38.0
|
21 percentage of days
Interval 14.0 to 31.0
|
21 percentage of days
Interval 14.0 to 30.0
|
23 percentage of days
Interval 14.0 to 38.0
|
SECONDARY outcome
Timeframe: during hospital admission (up to 28 days)Population: Participants were re-grouped and analyzed based on the following pre-specified factorial combinations: IL-1 Blockade, No IL-1 Blockade, IL-6 Blockade, No IL-6 Blockade
Outcome measures
| Measure |
IL 1 Blockade
n=112 Participants
All patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital). Some patients also received Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
No IL-1 Blockade
n=230 Participants
Some patients received IL-6 blockade with Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC
|
IL-6 Blockade
n=227 Participants
Patients received either Sylvant® (Siltuximab) single IV infusion from 100mg powder concentrate and 400mg powder concentrate, OR Roactemra® (tocilizumab) IV- Infusion prepared starting from flasks containing 400mg/20ml stock solution (to dilute for infusion) or from Prefilled syringe 162mg / 0.9ml SC Some patients also received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
No IL-6 Blockade
n=115 Participants
Some patients received Kineret® (Anakinra) 100mg pre-filled syringe given 1x / day for 28 days (or until discharge from hospital)
|
|---|---|---|---|---|
|
Time Until First Use of High-flow Oxygen Device, Ventilation, or Death
|
NA days
\< 50% reached event
|
NA days
\< 50% reached event
|
NA days
\< 50% reached event
|
NA days
\< 50% reached event
|
Adverse Events
Anakinra + Siltuximab
Serious events: 8 serious events
Other events: 17 other events
Deaths: 6 deaths
Usual Care
Serious events: 14 serious events
Other events: 37 other events
Deaths: 9 deaths
Anakinra
Serious events: 12 serious events
Other events: 25 other events
Deaths: 10 deaths
Siltuximab
Serious events: 21 serious events
Other events: 15 other events
Deaths: 15 deaths
Tocilizumab
Serious events: 15 serious events
Other events: 35 other events
Deaths: 10 deaths
Anakinra + Tocilizumab
Serious events: 9 serious events
Other events: 17 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Anakinra + Siltuximab
n=36 participants at risk
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Usual Care
n=74 participants at risk
Usual Care: Usual Care
|
Anakinra
n=44 participants at risk
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
|
Siltuximab
n=75 participants at risk
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Tocilizumab
n=81 participants at risk
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
Anakinra + Tocilizumab
n=32 participants at risk
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Arterial thromboembolism
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
28.0%
21/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Surgical and medical procedures
Other
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Immune system disorders
Anaphylaxis
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
General disorders
Disease progression
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
General disorders
Multi-organ failure
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Injury, poisoning and procedural complications
postoperative haemorrhage
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Cardiac disorders
Asystole
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Cardiac disorders
Other
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
11.4%
5/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
12.0%
9/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
7.4%
6/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Blood and lymphatic system disorders
Other
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Edema cerebral
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Nervous system disorders
Intracranial haemorrhage
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Gastrointestinal disorders
Jejunal haemorrhage
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Metabolism and nutrition disorders
Acidosis
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Sepsis
|
8.3%
3/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
11.4%
5/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
8.0%
6/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
Other adverse events
| Measure |
Anakinra + Siltuximab
n=36 participants at risk
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Usual Care
n=74 participants at risk
Usual Care: Usual Care
|
Anakinra
n=44 participants at risk
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
|
Siltuximab
n=75 participants at risk
Siltuximab: Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
|
Tocilizumab
n=81 participants at risk
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
Anakinra + Tocilizumab
n=32 participants at risk
Anakinra: Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
Tocilizumab: Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
|
|---|---|---|---|---|---|---|
|
Investigations
Creatinine increased
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Investigations
GGT increased
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.7%
5/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.3%
7/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.4%
3/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
10.7%
8/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
11.4%
5/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
3/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Blood and lymphatic system disorders
Other
|
11.1%
4/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.7%
3/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Gastrointestinal disorders
Constipation
|
11.1%
4/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
13.5%
10/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
11.4%
5/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
12.0%
9/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.9%
8/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
21.9%
7/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Psychiatric disorders
Diarrhoea
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.0%
3/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Psychiatric disorders
Gastroparesis
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.7%
3/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.4%
4/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Renal and urinary disorders
Other
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.4%
3/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.7%
3/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.0%
3/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.4%
3/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Metabolism and nutrition disorders
Other
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.7%
5/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.7%
2/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
2/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Lung infection
|
8.3%
3/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.5%
7/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.1%
4/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
10.7%
8/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.9%
8/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
15.6%
5/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.7%
5/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.5%
2/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.4%
4/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
2.3%
1/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Vascular disorders
Hypertension
|
2.8%
1/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.4%
4/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.7%
3/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.4%
3/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.4%
4/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.3%
1/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.2%
1/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
1.4%
1/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
5.3%
4/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.7%
3/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
3/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.8%
3/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
9.3%
7/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
8.6%
7/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
3.1%
1/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
2/36 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.1%
3/74 • AE's are recorded from randomisation until the end of the study, 5 months
|
4.5%
2/44 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.7%
5/75 • AE's are recorded from randomisation until the end of the study, 5 months
|
6.2%
5/81 • AE's are recorded from randomisation until the end of the study, 5 months
|
0.00%
0/32 • AE's are recorded from randomisation until the end of the study, 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place