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Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza (IRC002)

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ClinicalTrials.gov Identifier: NCT01052480
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : May 23, 2017
Last Update Posted : September 5, 2017
Sponsor:
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: None (Open Label);   Primary Purpose: Treatment
Conditions Influenza A
Influenza B
Interventions Biological: Anti-Influenza Immune Plasma
Drug: Standard Care
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Period Title: Overall Study
Started 49 49
Completed 41 32
Not Completed 8 17
Reason Not Completed
Lost to Follow-up             3             3
Protocol Violation             1             0
Withdrawal by Subject             3             7
Physician Decision             0             2
Death             1             5
Arm/Group Title Plasma and Standard Care Standard Care Total
Hide Arm/Group Description

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Total of all reporting groups
Overall Number of Baseline Participants 49 49 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 49 participants 49 participants 98 participants
50
(38 to 66)
57
(39 to 71)
53
(38 to 69)
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
<18
4
   8.2%
7
  14.3%
11
  11.2%
>=18
45
  91.8%
42
  85.7%
87
  88.8%
[1]
Measure Description: The <18 and >=18 categories match a protocol-specified division, so it is most appropriate to present categorized age this way.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Female
24
  49.0%
27
  55.1%
51
  52.0%
Male
25
  51.0%
22
  44.9%
47
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Hispanic or Latino
4
   8.2%
6
  12.2%
10
  10.2%
Not Hispanic or Latino
43
  87.8%
39
  79.6%
82
  83.7%
Unknown or Not Reported
2
   4.1%
4
   8.2%
6
   6.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  32.7%
9
  18.4%
25
  25.5%
White
29
  59.2%
32
  65.3%
61
  62.2%
More than one race
1
   2.0%
2
   4.1%
3
   3.1%
Unknown or Not Reported
3
   6.1%
5
  10.2%
8
   8.2%
1.Primary Outcome
Title Time to Normalization of Respiratory Status (Primary Efficacy Population)
Hide Description Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
7 [1] 
(2 to NA)
28 [1] 
(7 to NA)
[1]
Upper quartile is not available because fewer than 75% of the analyzed participants achieved normalized respiratory status. Lower quartile and median were estimated from Kaplan-Meier analysis.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Plasma and Standard Care, Standard Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Time to Normalization of Respiratory Status (All Randomized Participants)
Hide Description Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 49 49
Median (Inter-Quartile Range)
Unit of Measure: days
14 [1] 
(2 to NA)
NA [2] 
(7 to NA)
[1]
Upper quartile is not available because fewer than 75% of the analyzed participants achieved normalized respiratory status. Lower quartile and median were estimated from Kaplan-Meier analysis.
[2]
Median and upper quartile are not available because fewer than 50% of the analyzed participants achieved normalized respiratory status. Lower quartile was estimated from Kaplan-Meier analysis.
3.Secondary Outcome
Title Duration of Time to Resolution of Clinical Symptoms
Hide Description The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(14 to NA)
NA [1] 
(28 to NA)
[1]
Median and upper quartile are not available because fewer than 50% of the analyzed participants had symptoms resolved. Lower quartile was estimated from Kaplan-Meier analysis
4.Secondary Outcome
Title Duration of Time to Resolution of Fever
Hide Description Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(0 to NA)
NA [1] 
(0 to NA)
[1]
Median and upper quartile are not available because nearly all participants had no fever at Day 0. Lower quartile was estimated from Kaplan-Meier analysis.
5.Secondary Outcome
Title Duration of Time to Resolution of All Symptoms and Fever
Hide Description The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(14 to NA)
NA [1] 
(28 to NA)
[1]
Median and upper quartile are not available because fewer than 50% of the analyzed participants had all symptoms and fever resolved. Lower quartile was estimated from Kaplan-Meier analysis.
6.Secondary Outcome
Title Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old
Hide Description The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those >= 18 years with an available (non-zero) Day 0 SOFA evaluation.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 28 33
Median (Inter-Quartile Range)
Unit of Measure: days
4 [1] 
(2 to NA)
28 [1] 
(7 to NA)
[1]
Upper quartile is not available because fewer than 75% of the analyzed participants had 20% improvement in SOFA score. Median and lower quartile were estimated from Kaplan-Meier analysis.
7.Secondary Outcome
Title 50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time
Hide Description Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.
Time Frame Measured at Days 1, 2, 4, 7, 14, 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with a PaO2/FiO2 ratio (ABG performed) at Day 0.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 25 29
Measure Type: Number
Unit of Measure: participants
Day 1 11 14
Day 2 12 12
Day 4 7 11
Day 7 7 9
Day 14 3 5
Day 28 2 3
8.Secondary Outcome
Title In-hospital Mortality
Hide Description Number of deaths in hospital during initial hospital admission
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 49 49
Measure Type: Number
Unit of Measure: participants
1 5
9.Secondary Outcome
Title 28-day Mortality
Hide Description Number of deaths during study follow-up
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 49 49
Measure Type: Number
Unit of Measure: participants
1 5
10.Secondary Outcome
Title Duration of Hospitalization
Hide Description Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
6
(4 to 16)
11
(5 to 25)
11.Secondary Outcome
Title Number of ICU Admissions
Hide Description Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Measure Type: Number
Unit of Measure: participants
1 ICU admission 40 38
2 ICU admissions 2 5
4 ICU admissions 0 2
12.Secondary Outcome
Title Duration of Stay in ICU
Hide Description Days that a participant spent in ICU. Multiple ICU admissions are summed up.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
2.5
(0 to 9)
3
(0 to 13)
13.Secondary Outcome
Title Days on Supplemental Oxygen
Hide Description Time (in days) of supplemental oxygen use
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
7
(1 to 28)
8
(3 to 28)
14.Secondary Outcome
Title Duration of Supplemental Oxygen
Hide Description Duration of supplemental oxygen use in days
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
7
(1 to 28)
8
(3 to 28)
15.Secondary Outcome
Title Incidence of Acute Respiratory Distress Syndrome (ARDS) Present
Hide Description Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.
Time Frame Measured at Days 0, 1, 2, 4, 7, 14, 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This population is further restricted to those participants who did not have ARDS at Day 0.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: participants
0 3
16.Secondary Outcome
Title Days on Mechanical Ventilation
Hide Description Time (in days) of mechanical ventilation use
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
0
(0 to 6)
3
(0 to 14)
17.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: days
0
(0 to 6)
3
(0 to 14)
18.Secondary Outcome
Title Disposition Following Initial Hospitalization
Hide Description Disposition following initial hospitalization was categorized as follows: "released home - home health care not required", " released home with home health care", "transferred to long-term care facility", "hospitalization ongoing at Day 28", "deceased".
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 42 45
Measure Type: Number
Unit of Measure: participants
released home - home health care not required 21 17
released home with home health care 9 6
transferred to long-term care facility 4 6
hospitalization ongoing at Day 28 7 9
deceased 1 5
19.Secondary Outcome
Title Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs
Hide Description Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with viral shedding >= LLOQ in nasal swabs at Day 0.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 27 35
Median (Inter-Quartile Range)
Unit of Measure: days
1 [1] 
(1 to NA)
1 [1] 
(1 to NA)
[1]
Upper quartile is not available because fewer than 75% of the analyzed participants had viral shedding < LLOQ in nasal swabs. Lower quartile and median were estimated from Kaplan-Meier analysis.
20.Secondary Outcome
Title Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women
Hide Description Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants
Time Frame Measured through to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women
Hide Description Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants
Time Frame Measured through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women
Hide Description Incidence of spontaneous abortion or stillborn fetus for pregnant female participants
Time Frame Measured from Day 0 through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.
Arm/Group Title Plasma and Standard Care Standard Care
Hide Arm/Group Description:

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28
Adverse Event Reporting Description Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
 
Arm/Group Title Plasma and Standard Care Standard Care
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Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

All-Cause Mortality
Plasma and Standard Care Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   1/49 (2.04%)   5/49 (10.20%) 
Show Serious Adverse Events Hide Serious Adverse Events
Plasma and Standard Care Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   9/46 (19.57%)   20/52 (38.46%) 
Blood and lymphatic system disorders     
Leukocytosis  1  0/46 (0.00%)  1/52 (1.92%) 
Anaemia  1  0/46 (0.00%)  1/52 (1.92%) 
Cardiac disorders     
Atrial fibrillation  1  0/46 (0.00%)  1/52 (1.92%) 
Cardiac arrest  1  0/46 (0.00%)  1/52 (1.92%) 
Cardiogenic shock  1  0/46 (0.00%)  1/52 (1.92%) 
Supraventricular tachycardia  1  1/46 (2.17%)  0/52 (0.00%) 
Gastrointestinal disorders     
Intestinal ischaemia  1  0/46 (0.00%)  2/52 (3.85%) 
Gastrointestinal haemorrhage  1  0/46 (0.00%)  1/52 (1.92%) 
Abdominal compartment syndrome  1  0/46 (0.00%)  1/52 (1.92%) 
Retroperitoneal haemorrhage  1  0/46 (0.00%)  1/52 (1.92%) 
General disorders     
Chest pain  1  0/46 (0.00%)  1/52 (1.92%) 
Hepatobiliary disorders     
Hepatic haematoma  1  0/46 (0.00%)  1/52 (1.92%) 
Portal vein thrombosis  1  0/46 (0.00%)  1/52 (1.92%) 
Liver injury  1  1/46 (2.17%)  0/52 (0.00%) 
Infections and infestations     
Septic shock  1  1/46 (2.17%)  1/52 (1.92%) 
Clostridium difficile colitis  1  1/46 (2.17%)  0/52 (0.00%) 
Lower respiratory tract infection viral  1  0/46 (0.00%)  1/52 (1.92%) 
Sepsis  1  0/46 (0.00%)  1/52 (1.92%) 
Pneumonia  1  0/46 (0.00%)  1/52 (1.92%) 
Injury, poisoning and procedural complications     
Post procedural haemorrhage  1  1/46 (2.17%)  0/52 (0.00%) 
Investigations     
Blood creatine phosphokinase MB increased  1  1/46 (2.17%)  0/52 (0.00%) 
Activated partial thromboplastin time prolonged  1  0/46 (0.00%)  1/52 (1.92%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/46 (0.00%)  2/52 (3.85%) 
Gout  1  1/46 (2.17%)  0/52 (0.00%) 
Hypernatraemia  1  1/46 (2.17%)  0/52 (0.00%) 
Acidosis  1  0/46 (0.00%)  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  0/46 (0.00%)  1/52 (1.92%) 
Nervous system disorders     
Cerebrovascular accident  1  1/46 (2.17%)  2/52 (3.85%) 
Cerebral infarction  1  1/46 (2.17%)  0/52 (0.00%) 
Subarachnoid haemorrhage  1  1/46 (2.17%)  0/52 (0.00%) 
Seizure  1  0/46 (0.00%)  1/52 (1.92%) 
Sedation  1  0/46 (0.00%)  1/52 (1.92%) 
Mental impairment  1  0/46 (0.00%)  1/52 (1.92%) 
Psychiatric disorders     
Mental status changes  1  0/46 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/46 (2.17%)  2/52 (3.85%) 
Pneumothorax  1  0/46 (0.00%)  2/52 (3.85%) 
Pulmonary thrombosis  1  0/46 (0.00%)  2/52 (3.85%) 
Respiratory distress  1  0/46 (0.00%)  1/52 (1.92%) 
Pulmonary embolism  1  0/46 (0.00%)  1/52 (1.92%) 
Pneumonia aspiration  1  0/46 (0.00%)  1/52 (1.92%) 
Respiratory failure  1  0/46 (0.00%)  2/52 (3.85%) 
Surgical and medical procedures     
Endotracheal intubation  1  0/46 (0.00%)  2/52 (3.85%) 
Thoracostomy  1  0/46 (0.00%)  1/52 (1.92%) 
Vascular disorders     
Hypotension  1  0/46 (0.00%)  1/52 (1.92%) 
Shock  1  0/46 (0.00%)  1/52 (1.92%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Plasma and Standard Care Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   36/46 (78.26%)   29/52 (55.77%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  5/46 (10.87%)  5/52 (9.62%) 
Anaemia  1  5/46 (10.87%)  4/52 (7.69%) 
Leukopenia  1  3/46 (6.52%)  1/52 (1.92%) 
Gastrointestinal disorders     
Diarrhoea  1  8/46 (17.39%)  2/52 (3.85%) 
Nausea  1  6/46 (13.04%)  2/52 (3.85%) 
Vomiting  1  0/46 (0.00%)  3/52 (5.77%) 
Constipation  1  3/46 (6.52%)  0/52 (0.00%) 
General disorders     
Pyrexia  1  5/46 (10.87%)  5/52 (9.62%) 
Investigations     
Blood glucose increased  1  5/46 (10.87%)  6/52 (11.54%) 
Aspartate aminotransferase increased  1  5/46 (10.87%)  5/52 (9.62%) 
Blood albumin decreased  1  4/46 (8.70%)  4/52 (7.69%) 
Blood creatinine increased  1  3/46 (6.52%)  3/52 (5.77%) 
Blood uric acid increased  1  1/46 (2.17%)  4/52 (7.69%) 
Alanine aminotransferase increased  1  1/46 (2.17%)  4/52 (7.69%) 
Blood sodium decreased  1  3/46 (6.52%)  2/52 (3.85%) 
Haemoglobin decreased  1  2/46 (4.35%)  3/52 (5.77%) 
Blood bilirubin increased  1  1/46 (2.17%)  3/52 (5.77%) 
Blood sodium increased  1  1/46 (2.17%)  3/52 (5.77%) 
Blood creatine phosphokinase increased  1  3/46 (6.52%)  1/52 (1.92%) 
Lymphocyte count decreased  1  3/46 (6.52%)  0/52 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  6/46 (13.04%)  1/52 (1.92%) 
Hypernatraemia  1  5/46 (10.87%)  1/52 (1.92%) 
Hyperglycaemia  1  3/46 (6.52%)  2/52 (3.85%) 
Alkalosis  1  3/46 (6.52%)  0/52 (0.00%) 
Nervous system disorders     
Headache  1  5/46 (10.87%)  2/52 (3.85%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/46 (17.39%)  0/52 (0.00%) 
Oropharyngeal pain  1  4/46 (8.70%)  4/52 (7.69%) 
Dyspnoea  1  3/46 (6.52%)  4/52 (7.69%) 
Vascular disorders     
Hypotension  1  3/46 (6.52%)  1/52 (1.92%) 
1
Term from vocabulary, MedDRA 18.1
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
Name/Title: John Beigel, M.D.
Organization: Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-451-9881
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01052480     History of Changes
Other Study ID Numbers: 10-I-0043
IRC002 ( Other Identifier: NIAID Influenza Research Collaboration )
First Submitted: January 16, 2010
First Posted: January 20, 2010
Results First Submitted: April 19, 2017
Results First Posted: May 23, 2017
Last Update Posted: September 5, 2017