Trial Outcomes & Findings for Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza (NCT NCT02287467)
NCT ID: NCT02287467
Last Updated: 2019-11-14
Results Overview
This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
329 participants
Primary outcome timeframe
Assessed on Day 7
Results posted on
2019-11-14
Participant Flow
Participant milestones
| Measure |
Arm A: hIVIG
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive standard of care (SOC )treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
161
|
|
Overall Study
COMPLETED
|
156
|
152
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
| Measure |
Arm A: hIVIG
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive standard of care (SOC )treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Overall Study
Protocol Violation
|
12
|
9
|
Baseline Characteristics
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
Baseline characteristics by cohort
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black/African American
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White/Caucasian
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
National Early Warning (NEW) score
|
4 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed on Day 7Population: All infused participants, using multiple imputation to impute outcome for 4 participants with missing data.
This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
Outcome measures
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Died
|
3 Participants
|
2 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized, in ICU
|
6 Participants
|
11 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Non-ICU hospitalization, using supplemental oxygen
|
15 Participants
|
16 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Non-ICU hospitalization, no supplemental oxygen
|
8 Participants
|
12 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Discharged, not back to normal activities
|
56 Participants
|
51 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Discharged, back to normal activities
|
68 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Assessed on Day 3Population: All participants
5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).
Outcome measures
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients in Each of 5 Clinical Status Categories on Day 3
Death
|
1 Participants
|
0 Participants
|
|
Number of Patients in Each of 5 Clinical Status Categories on Day 3
Hospitalized, in ICU
|
8 Participants
|
13 Participants
|
|
Number of Patients in Each of 5 Clinical Status Categories on Day 3
Non-ICU hospitalization, NEW score 3+
|
25 Participants
|
31 Participants
|
|
Number of Patients in Each of 5 Clinical Status Categories on Day 3
Non-ICU hospitalization, NEW score < 3
|
55 Participants
|
46 Participants
|
|
Number of Patients in Each of 5 Clinical Status Categories on Day 3
Discharged
|
67 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Measured on Day 3Population: All participants with clinical data available on Day 3
6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).
Outcome measures
| Measure |
Arm A: hIVIG
n=155 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Death
|
1 Participants
|
0 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Hospitalized, in ICU
|
8 Participants
|
13 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Non-ICU hospitalization, on supplemental oxygen
|
37 Participants
|
34 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Non-ICU hospitalizaiton, no supplemental oxygen
|
43 Participants
|
43 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Discharged, not back to normal activities
|
53 Participants
|
53 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Discharged, back to normal activities
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Assessed on Day 7Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.
Outcome measures
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients With a Favorable Outcome on Day 7
favorable outcome
|
128 Participants
|
115 Participants
|
|
Number of Patients With a Favorable Outcome on Day 7
unfavorable outcome
|
28 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Measured through Day 7Population: All participants
Number of participants alive and discharged from the hospital
Outcome measures
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Hospital Discharge
Discharged alive
|
119 Participants
|
110 Participants
|
|
Hospital Discharge
Not discharged alive
|
37 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Measured through day 28Population: all participants
Number of participants dying through day 28.
Outcome measures
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Mortality
Died
|
6 Participants
|
5 Participants
|
|
Mortality
Did not die
|
150 Participants
|
147 Participants
|
SECONDARY outcome
Timeframe: Measured through Day 28Population: All participants with vital status known on Day 28
Number and percent alive and out of hospital on day 28
Outcome measures
| Measure |
Arm A: hIVIG
n=155 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=151 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients Alive and Out of Hospital
Alive and out of hospital
|
140 Participants
|
137 Participants
|
|
Number of Patients Alive and Out of Hospital
Died or hospitalized
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: Participants with viral load results at both baseline and day 3. Participants with undetectable viral load results at baseline are excluded.
Change in nasopharyngeal viral load from baseline to day 3
Outcome measures
| Measure |
Arm A: hIVIG
n=134 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=136 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Change in Viral Load
|
-1.99 log10 RNA
Standard Error .16
|
-2.32 log10 RNA
Standard Error .17
|
SECONDARY outcome
Timeframe: Day 28Population: all participants with data
Number and percent of participants who died or were re-hospitalized after initial discharge
Outcome measures
| Measure |
Arm A: hIVIG
n=150 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=146 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Death or Re-hospitalization
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Measured through Day 28Population: all participants
Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis
Outcome measures
| Measure |
Arm A: hIVIG
n=156 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Percent of Participants Developing Complications
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Measured on day 14Population: participants with observed data on day 14
6-category ordinal outcome measured on day 14
Outcome measures
| Measure |
Arm A: hIVIG
n=152 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=151 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Died
|
4 Participants
|
4 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Hospitalized in ICU
|
5 Participants
|
6 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Hospitalized on supplement oxygen
|
8 Participants
|
5 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Hospitalized not on supplemental oxygen
|
4 Participants
|
11 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Discharged, not back to normal activities
|
29 Participants
|
33 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Discharged, back to normal activities
|
102 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: day 14Population: all participants
Number and percentage of participants alive and out of the hospital on Day 14
Outcome measures
| Measure |
Arm A: hIVIG
n=155 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=151 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients Alive and Out of Hospital on Day 14
|
134 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: day 14Population: Participants with observed data
Participants reporting resumption of normal daily activities by Day 14
Outcome measures
| Measure |
Arm A: hIVIG
n=152 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=151 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Resumption of Normal Activities by Day 14
|
102 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: day 28Population: participants with observed data
6-category ordinal outcome corresponding to clinical status on day 28
Outcome measures
| Measure |
Arm A: hIVIG
n=151 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=150 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Hospitalized, not on supplemental oxygen
|
1 Participants
|
5 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Discharged, not back to normal activities
|
21 Participants
|
22 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Discharged, back to normal activities
|
115 Participants
|
114 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Died
|
6 Participants
|
5 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Hospitalized in ICU
|
2 Participants
|
2 Participants
|
|
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Hospitalized, on supplemental oxygen
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: all participants infected with influenza A
Primary 6-category ordinal outcome for participants infected with Influenza A
Outcome measures
| Measure |
Arm A: hIVIG
n=114 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=110 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Died
|
3 Participants
|
0 Participants
|
|
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized in ICU
|
5 Participants
|
7 Participants
|
|
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized on supplemental oxygen
|
14 Participants
|
9 Participants
|
|
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized not on supplemental oxygen
|
7 Participants
|
10 Participants
|
|
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Discharged, not back to normal activities
|
40 Participants
|
39 Participants
|
|
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Discharged, back to normal activities
|
45 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Day 7Primary 6-category ordinal outcome for subgroup of participants infected with influenza B
Outcome measures
| Measure |
Arm A: hIVIG
n=42 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=42 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Died
|
0 Participants
|
2 Participants
|
|
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized in ICU
|
1 Participants
|
4 Participants
|
|
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized on supplemental oxygen
|
1 Participants
|
7 Participants
|
|
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hospitalized not on supplemental oxygen
|
1 Participants
|
2 Participants
|
|
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Discharged, not back to normal activities
|
16 Participants
|
12 Participants
|
|
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Discharged, back to normal activities
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: participants infected with pH1N1 with HAI titers measured at day 7
pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus
Outcome measures
| Measure |
Arm A: hIVIG
n=23 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=26 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
pH1N1 Titers at Day 7
|
285 titer
Standard Deviation 374
|
229 titer
Standard Deviation 341
|
SECONDARY outcome
Timeframe: Day 7Population: participants infected with H3N2 with HAI titers measured at day 7
H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus
Outcome measures
| Measure |
Arm A: hIVIG
n=54 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=49 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
H3N2 Titers at Day 7
|
259 titer
Standard Deviation 291
|
225 titer
Standard Deviation 277
|
SECONDARY outcome
Timeframe: Day 7Population: participants infected with influenza B with HAI titers measured at day 7
Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus
Outcome measures
| Measure |
Arm A: hIVIG
n=39 Participants
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=40 Participants
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Influenza B Titers at Day 7
|
112 titer
Standard Deviation 161
|
84 titer
Standard Deviation 83
|
Adverse Events
Arm A: hIVIG
Serious events: 25 serious events
Other events: 13 other events
Deaths: 6 deaths
Arm B: Placebo
Serious events: 26 serious events
Other events: 14 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm A: hIVIG
n=156 participants at risk
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 participants at risk
Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
2/156 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
1.3%
2/152 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Gastrointestinal disorders
Nausea
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Influenza
|
1.3%
2/156 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Pneumonia bacterial
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Pyelonephritis
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Sepsis
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Infections and infestations
Septic shock
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Investigations
Blood creatinine increased
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.64%
1/156 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Nervous system disorders
Dizziness
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Nervous system disorders
Headache
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Psychiatric disorders
Dysthymic disorders
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
1.3%
2/152 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
3.3%
5/152 • Number of events 8 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/156 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.00%
0/152 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
1.3%
2/152 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Vascular disorders
Hypotension
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/156 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
Other adverse events
| Measure |
Arm A: hIVIG
n=156 participants at risk
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
|
Arm B: Placebo
n=152 participants at risk
Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo for IVIG: Administered IV as 500 mL of normal saline
|
|---|---|---|
|
Investigations
Blood creatinine increased
|
2.6%
4/156 • Number of events 5 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
0.66%
1/152 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
5/156 • Number of events 5 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
2.6%
4/152 • Number of events 4 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
4/156 • Number of events 5 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
2.0%
3/152 • Number of events 3 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Investigations
Haemoglobin decreased
|
1.3%
2/156 • Number of events 4 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
2.6%
4/152 • Number of events 6 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.64%
1/156 • Number of events 1 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
2.6%
4/152 • Number of events 4 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
2/156 • Number of events 2 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
2.6%
4/152 • Number of events 4 • 28 days
Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place