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Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02287467
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
University of Minnesota
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Influenza A
Influenza B
Interventions Biological: Intravenous hyperimmune immunoglobulin (IVIG)
Biological: Placebo for IVIG
Enrollment 329
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description

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)

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

Period Title: Overall Study
Started 168 161
Completed 156 152
Not Completed 12 9
Reason Not Completed
Protocol Violation             12             9
Arm/Group Title Arm A: hIVIG Arm B: Placebo Total
Hide Arm/Group Description

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)

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 of all reporting groups
Overall Number of Baseline Participants 156 152 308
Hide Baseline Analysis Population Description
Participants in the analysis data set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 152 participants 308 participants
<=18 years
1
   0.6%
1
   0.7%
2
   0.6%
Between 18 and 65 years
109
  69.9%
100
  65.8%
209
  67.9%
>=65 years
46
  29.5%
51
  33.6%
97
  31.5%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 156 participants 152 participants 308 participants
55
(41 to 68)
57
(48 to 68)
57
(45 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 152 participants 308 participants
Female
80
  51.3%
88
  57.9%
168
  54.5%
Male
76
  48.7%
64
  42.1%
140
  45.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/ethnicity Number Analyzed 156 participants 152 participants 308 participants
Asian
33
  21.2%
36
  23.7%
69
  22.4%
Black/African American
27
  17.3%
30
  19.7%
57
  18.5%
Hispanic
27
  17.3%
24
  15.8%
51
  16.6%
White/Caucasian
67
  42.9%
61
  40.1%
128
  41.6%
Other
2
   1.3%
1
   0.7%
3
   1.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 152 participants 308 participants
United States
91
  58.3%
84
  55.3%
175
  56.8%
United Kingdom
8
   5.1%
10
   6.6%
18
   5.8%
Australia
5
   3.2%
5
   3.3%
10
   3.2%
Argentina
4
   2.6%
4
   2.6%
8
   2.6%
Denmark
5
   3.2%
3
   2.0%
8
   2.6%
Spain
5
   3.2%
5
   3.3%
10
   3.2%
Greece
5
   3.2%
4
   2.6%
9
   2.9%
Mexico
1
   0.6%
2
   1.3%
3
   1.0%
Thailand
32
  20.5%
35
  23.0%
67
  21.8%
National Early Warning (NEW) score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 156 participants 152 participants 308 participants
4
(2 to 6)
4
(2 to 6)
4
(2 to 6)
[1]
Measure Description: National Early Warning score measured on day of randomization. The NEW score is a morbidity index based on 6 vital signs (respiratory rate, oxygen saturation, temperature, blood pressure, pulse/heart rate, level of consciousness). Each component is scored from 0 to 3 (best to worst) and the components are summed. Thus the composite score can range from 0 to 18.
1.Primary Outcome
Title Number of Patients in Each of 6 Clinical Status Categories on Day 7
Hide Description This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
Time Frame Assessed on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All infused participants, using multiple imputation to impute outcome for 4 participants with missing data.
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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

Overall Number of Participants Analyzed 156 152
Measure Type: Count of Participants
Unit of Measure: Participants
Died
3
   1.9%
2
   1.3%
Hospitalized, in ICU
6
   3.8%
11
   7.2%
Non-ICU hospitalization, using supplemental oxygen
15
   9.6%
16
  10.5%
Non-ICU hospitalization, no supplemental oxygen
8
   5.1%
12
   7.9%
Discharged, not back to normal activities
56
  35.9%
51
  33.6%
Discharged, back to normal activities
68
  43.6%
60
  39.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .33
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline clinical status, region, and participation in the pilot study.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.79 to 1.97
Estimation Comments Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.
2.Secondary Outcome
Title Number of Patients in Each of 5 Clinical Status Categories on Day 3
Hide Description 5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).
Time Frame Assessed on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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

Overall Number of Participants Analyzed 156 152
Measure Type: Count of Participants
Unit of Measure: Participants
Death
1
   0.6%
0
   0.0%
Hospitalized, in ICU
8
   5.1%
13
   8.6%
Non-ICU hospitalization, NEW score 3+
25
  16.0%
31
  20.4%
Non-ICU hospitalization, NEW score < 3
55
  35.3%
46
  30.3%
Discharged
67
  42.9%
62
  40.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Odds ratio for being in a better category, from a proportional odds model
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .84
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline clinical status, region, and participation in the pilot study.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.61 to 1.48
Estimation Comments Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.
3.Secondary Outcome
Title Number of Patients in Each of 6 Clinical Status Categories on Day 3
Hide Description 6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).
Time Frame Measured on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with clinical data available on Day 3
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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

Overall Number of Participants Analyzed 155 152
Measure Type: Count of Participants
Unit of Measure: Participants
Death
1
   0.6%
0
   0.0%
Hospitalized, in ICU
8
   5.2%
13
   8.6%
Non-ICU hospitalization, on supplemental oxygen
37
  23.9%
34
  22.4%
Non-ICU hospitalizaiton, no supplemental oxygen
43
  27.7%
43
  28.3%
Discharged, not back to normal activities
53
  34.2%
53
  34.9%
Discharged, back to normal activities
13
   8.4%
9
   5.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Odds ratio for being in a better group, from a proportional odds model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .52
Comments [Not Specified]
Method Regression, Cox
Comments adjusted for baseline clinical status, region, and participation in the pilot study.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.57 to 1.33
Estimation Comments Odds ratio is for hIVIG vs. placebo. An odds ratio > 1 favors the hIVIG group.
4.Secondary Outcome
Title Number of Patients With a Favorable Outcome on Day 7
Hide Description Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.
Time Frame Assessed on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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

Overall Number of Participants Analyzed 156 152
Measure Type: Count of Participants
Unit of Measure: Participants
favorable outcome
128
  82.1%
115
  75.7%
unfavorable outcome
28
  17.9%
37
  24.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .20
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in the pilot study.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
0.81 to 2.74
Estimation Comments Odds ratio for hIVIG vs placebo. An odds ratio > 1.0 favors the hIVIG group.
5.Secondary Outcome
Title Hospital Discharge
Hide Description Number of participants alive and discharged from the hospital
Time Frame Measured through Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 156 152
Measure Type: Count of Participants
Unit of Measure: Participants
Discharged alive
119
  76.3%
110
  72.4%
Not discharged alive
37
  23.7%
42
  27.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Deaths during hospitalization are censored after day 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .44
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by baseline clinical status, region, and participation in the pilot study.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
.85 to 1.45
Estimation Comments hazard ratio is hIVIG vs placebo; a hazard ratio >1 favors the hIVIG group.
6.Secondary Outcome
Title Mortality
Hide Description Number of participants dying through day 28.
Time Frame Measured through day 28
Hide Outcome Measure Data
Hide Analysis Population Description
all participants
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

Participants will receive a single infusion of placebo for hIVIG, 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 Number of Participants Analyzed 156 152
Measure Type: Count of Participants
Unit of Measure: Participants
Died
6
   3.8%
5
   3.3%
Did not die
150
  96.2%
147
  96.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .40
Comments [Not Specified]
Method Regression, Cox
Comments stratified by baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
.48 to 6.15
Estimation Comments hazard ratio is for hIVIG vs placebo; a hazard ratio < 1.0 favors the hIVIG group.
7.Secondary Outcome
Title Number of Patients Alive and Out of Hospital
Hide Description Number and percent alive and out of hospital on day 28
Time Frame Measured through Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with vital status known on Day 28
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 155 151
Measure Type: Count of Participants
Unit of Measure: Participants
Alive and out of hospital
140
  90.3%
137
  90.7%
Died or hospitalized
15
   9.7%
14
   9.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .74
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
.38 to 1.98
Estimation Comments odds ratio is for hIVIG vs placebo; an odds ratio > 1.0 favors hIVIG
8.Secondary Outcome
Title Change in Viral Load
Hide Description Change in nasopharyngeal viral load from baseline to day 3
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with viral load results at both baseline and day 3. Participants with undetectable viral load results at baseline are excluded.
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

Participants will receive a single infusion of placebo for hIVIG, 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 Number of Participants Analyzed 134 136
Mean (Standard Error)
Unit of Measure: log10 RNA
-1.99  (.16) -2.32  (.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .49
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline RNA, geographic region, and influenza subtype
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-.26 to .54
Estimation Comments Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.
9.Secondary Outcome
Title Death or Re-hospitalization
Hide Description Number and percent of participants who died or were re-hospitalized after initial discharge
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
all participants with data
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 150 146
Measure Type: Count of Participants
Unit of Measure: Participants
19
  12.7%
19
  13.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .93
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.5 to 1.97
Estimation Comments Odds ratio is for hIVIG vs placebo.
10.Secondary Outcome
Title Percent of Participants Developing Complications
Hide Description Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis
Time Frame Measured through Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
all participants
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 156 152
Measure Type: Count of Participants
Unit of Measure: Participants
20
  12.8%
22
  14.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .81
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.5 to 1.82
Estimation Comments odds ratio is for hIVIG group vs placebo
11.Secondary Outcome
Title Number of Patients in Each of 6 Clinical Status Categories on Day 14
Hide Description 6-category ordinal outcome measured on day 14
Time Frame Measured on day 14
Hide Outcome Measure Data
Hide Analysis Population Description
participants with observed data on day 14
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 152 151
Measure Type: Count of Participants
Unit of Measure: Participants
Died
4
   2.6%
4
   2.6%
Hospitalized in ICU
5
   3.3%
6
   4.0%
Hospitalized on supplement oxygen
8
   5.3%
5
   3.3%
Hospitalized not on supplemental oxygen
4
   2.6%
11
   7.3%
Discharged, not back to normal activities
29
  19.1%
33
  21.9%
Discharged, back to normal activities
102
  67.1%
92
  60.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Proportional odds for being in a better category
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .55
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in the pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.70 to 1.95
Estimation Comments Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio > 1 favors the hIVIG group.
12.Secondary Outcome
Title Number of Patients Alive and Out of Hospital on Day 14
Hide Description Number and percentage of participants alive and out of the hospital on Day 14
Time Frame day 14
Hide Outcome Measure Data
Hide Analysis Population Description
all participants
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 155 151
Measure Type: Count of Participants
Unit of Measure: Participants
134
  86.5%
125
  82.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .77
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
.5 to 2.31
Estimation Comments odds ratio is for hIVIG vs placebo
13.Secondary Outcome
Title Resumption of Normal Activities by Day 14
Hide Description Participants reporting resumption of normal daily activities by Day 14
Time Frame day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

Participants will receive a single infusion of placebo for hIVIG, 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 Number of Participants Analyzed 152 151
Measure Type: Count of Participants
Unit of Measure: Participants
102
  67.1%
92
  60.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .34
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.7 to 2.34
Estimation Comments odds ratio is expressed as hIVIG vs placebo
14.Secondary Outcome
Title Number of Patients in Each of 6 Clinical Status Categories on Day 28
Hide Description 6-category ordinal outcome corresponding to clinical status on day 28
Time Frame day 28
Hide Outcome Measure Data
Hide Analysis Population Description
participants with observed data
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 151 150
Measure Type: Count of Participants
Unit of Measure: Participants
Died
6
   4.0%
5
   3.3%
Hospitalized in ICU
2
   1.3%
2
   1.3%
Hospitalized, on supplemental oxygen
6
   4.0%
2
   1.3%
Hospitalized, not on supplemental oxygen
1
   0.7%
5
   3.3%
Discharged, not back to normal activities
21
  13.9%
22
  14.7%
Discharged, back to normal activities
115
  76.2%
114
  76.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .73
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value .90
Confidence Interval (2-Sided) 95%
.50 to 1.62
Estimation Comments odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio >1 favors the hIVIG group.
15.Secondary Outcome
Title Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hide Description Primary 6-category ordinal outcome for participants infected with Influenza A
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
all participants infected with influenza A
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 114 110
Measure Type: Count of Participants
Unit of Measure: Participants
Died
3
   2.6%
0
   0.0%
Hospitalized in ICU
5
   4.4%
7
   6.4%
Hospitalized on supplemental oxygen
14
  12.3%
9
   8.2%
Hospitalized not on supplemental oxygen
7
   6.1%
10
   9.1%
Discharged, not back to normal activities
40
  35.1%
39
  35.5%
Discharged, back to normal activities
45
  39.5%
45
  40.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .82
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in the pilot study.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.55 to 1.59
Estimation Comments Odds ratio (hIVIG vs placebo) is for being in a better category.
16.Secondary Outcome
Title Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Hide Description Primary 6-category ordinal outcome for subgroup of participants infected with influenza B
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 42 42
Measure Type: Count of Participants
Unit of Measure: Participants
Died
0
   0.0%
2
   4.8%
Hospitalized in ICU
1
   2.4%
4
   9.5%
Hospitalized on supplemental oxygen
1
   2.4%
7
  16.7%
Hospitalized not on supplemental oxygen
1
   2.4%
2
   4.8%
Discharged, not back to normal activities
16
  38.1%
12
  28.6%
Discharged, back to normal activities
23
  54.8%
15
  35.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments Multiple imputation was used to estimate the outcome for one participant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for baseline clinical status, region, and participation in pilot study
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.19
Confidence Interval (2-Sided) 95%
1.21 to 8.42
Estimation Comments Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio > 1 favors the hIVIG group.
17.Secondary Outcome
Title pH1N1 Titers at Day 7
Hide Description pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
participants infected with pH1N1 with HAI titers measured at day 7
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 23 26
Mean (Standard Deviation)
Unit of Measure: titer
285  (374) 229  (341)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .18
Comments [Not Specified]
Method Mixed Models Analysis
Comments longitudinal regression with adjustment for baseline titer
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.84 to 2.7
Estimation Comments Ratio of hIVIG group to placebo group. A ratio > 1.0 indicates higher titers for the hIVIG group.
18.Secondary Outcome
Title H3N2 Titers at Day 7
Hide Description H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
participants infected with H3N2 with HAI titers measured at day 7
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 54 49
Mean (Standard Deviation)
Unit of Measure: titer
259  (291) 225  (277)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .13
Comments [Not Specified]
Method Mixed Models Analysis
Comments longitudinal analysis of log-transformed titers adjust for baseline titer.
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.93 to 1.8
Estimation Comments Ratio of geometric means of hIVIG vs placebo. A ratio >1.0 indicates higher titers in the hIVIG group on day 7.
19.Secondary Outcome
Title Influenza B Titers at Day 7
Hide Description Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
participants infected with influenza B with HAI titers measured at day 7
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: titer
112  (161) 84  (83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: hIVIG, Arm B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .78
Comments [Not Specified]
Method Mixed Models Analysis
Comments log-transformed titers adjusted for baseline titer
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.58 to 1.5
Estimation Comments ratio of geometric mean for hIVIG vs placebo. A ratio > 1.0 indicates higher titers at day 7 for the hIVIG group.
Time Frame 28 days
Adverse Event Reporting Description 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.
 
Arm/Group Title Arm A: hIVIG Arm B: Placebo
Hide Arm/Group Description

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)

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

All-Cause Mortality
Arm A: hIVIG Arm B: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/156 (3.85%)      5/152 (3.29%)    
Hide Serious Adverse Events
Arm A: hIVIG Arm B: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/156 (16.03%)      26/152 (17.11%)    
Blood and lymphatic system disorders     
Anaemia  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Leukopenia  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Cardiac disorders     
Acute myocardial infarction  1  2/156 (1.28%)  2 0/152 (0.00%)  0
Atrial fibrillation  1  0/156 (0.00%)  0 2/152 (1.32%)  2
Cardiac failure  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Gastrointestinal disorders     
Internal hernia  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Nausea  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Retroperitoneal haemorrhage  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Vomiting  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Infections and infestations     
Breast abscess  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Enterococcal bacteraemia  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Influenza  1  2/156 (1.28%)  2 0/152 (0.00%)  0
Pneumonia  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Pneumonia bacterial  1  1/156 (0.64%)  1 1/152 (0.66%)  1
Pneumonia fungal  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Pyelonephritis  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Sepsis  1  1/156 (0.64%)  1 1/152 (0.66%)  1
Septic shock  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Injury, poisoning and procedural complications     
Post lumbar puncture syndrome  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Rib fracture  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Road traffic accident  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Investigations     
Blood creatinine increased  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/156 (0.64%)  1 1/152 (0.66%)  1
Fluid overload  1  1/156 (0.64%)  2 0/152 (0.00%)  0
Hyperkalaemia  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Hypoglycaemia  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Haemorrhage intracranial  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Headache  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Vocal cord paresis  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Psychiatric disorders     
Dysthymic disorders  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/156 (0.00%)  0 2/152 (1.32%)  2
Renal failure  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Acute respiratory failure  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Aspiration  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Asthma  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Bronchospasm  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Chronic obstructive pulmonary disease  1  1/156 (0.64%)  1 5/152 (3.29%)  8
Dyspnoea  1  1/156 (0.64%)  1 1/152 (0.66%)  1
Hypoxia  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Pleural effusion  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Pneumonia aspiration  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Pulmonary embolism  1  2/156 (1.28%)  2 0/152 (0.00%)  0
Pulmonary oedema  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Respiratory distress  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Respiratory failure  1  1/156 (0.64%)  1 2/152 (1.32%)  2
Skin and subcutaneous tissue disorders     
Diabetic foot  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Vascular disorders     
Hypotension  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Thrombophlebitis superficial  1  0/156 (0.00%)  0 1/152 (0.66%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Arm A: hIVIG Arm B: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/156 (8.33%)      14/152 (9.21%)    
Investigations     
Blood creatinine increased  1  4/156 (2.56%)  5 1/152 (0.66%)  1
Haemoglobin decreased  1  2/156 (1.28%)  4 4/152 (2.63%)  6
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/156 (0.64%)  1 4/152 (2.63%)  4
Musculoskeletal and connective tissue disorders     
Myalgia  1  2/156 (1.28%)  2 4/152 (2.63%)  4
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/156 (3.21%)  5 4/152 (2.63%)  4
Dyspnoea  1  4/156 (2.56%)  5 3/152 (1.97%)  3
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Davey
Organization: NIAID
Phone: 301-496-8029
EMail: rdavey@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02287467    
Other Study ID Numbers: INSIGHT 006: FLU-IVIG
First Submitted: November 6, 2014
First Posted: November 10, 2014
Results First Submitted: September 20, 2019
Results First Posted: November 14, 2019
Last Update Posted: November 14, 2019