Trial Outcomes & Findings for Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza (NCT NCT01052480)

Last Updated: 2017-09-05

Results Overview

Normalized respiratory status is defined as room air saturation of oxygen \[SaO2\] greater than or equal to 93% AND respiratory rate within normal ranges.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

Measured from Day 0 through Day 28

Results posted on

2017-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Plasma and Standard Care 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	Standard Care Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Overall Study STARTED	49	49
Overall Study COMPLETED	41	32
Overall Study NOT COMPLETED	8	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Plasma and Standard Care 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	Standard Care Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Overall Study Lost to Follow-up	3	3
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	3	7
Overall Study Physician Decision	0	2
Overall Study Death	1	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plasma and Standard Care n=49 Participants 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	Standard Care n=49 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza	Total n=98 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	57 years n=7 Participants	53 years n=5 Participants
Age, Customized <18	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Age, Customized >=18	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Normalized respiratory status is defined as room air saturation of oxygen \[SaO2\] greater than or equal to 93% AND respiratory rate within normal ranges.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Time to Normalization of Respiratory Status (Primary Efficacy Population)	7 days Interval 2.0 to 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.	28 days Interval 7.0 to 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.

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: All randomized participants

Normalized respiratory status is defined as room air saturation of oxygen \[SaO2\] greater than or equal to 93% AND respiratory rate within normal ranges.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=49 Participants 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	Standard Care n=49 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Time to Normalization of Respiratory Status (All Randomized Participants)	14 days Interval 2.0 to 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.	NA days Interval 7.0 to 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.

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

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.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Time to Resolution of Clinical Symptoms	NA days Interval 14.0 to 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	NA days Interval 28.0 to 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

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Fever was defined as either a temperature \> 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Time to Resolution of Fever	NA days Interval 0.0 to 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.	NA days Interval 0.0 to 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.

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

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.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Time to Resolution of All Symptoms and Fever	NA days Interval 14.0 to 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.	NA days Interval 28.0 to 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.

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=28 Participants 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	Standard Care n=33 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
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	4 days Interval 2.0 to 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.	28 days Interval 7.0 to 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.

SECONDARY outcome

Timeframe: Measured at Days 1, 2, 4, 7, 14, 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=25 Participants 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	Standard Care n=29 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time Day 1	11 participants	14 participants
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time Day 2	12 participants	12 participants
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time Day 4	7 participants	11 participants
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time Day 7	7 participants	9 participants
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time Day 14	3 participants	5 participants
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time Day 28	2 participants	3 participants

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: All randomized participants

Number of deaths in hospital during initial hospital admission

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=49 Participants 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	Standard Care n=49 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
In-hospital Mortality	1 participants	5 participants

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: All randomized participants

Number of deaths during study follow-up

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=49 Participants 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	Standard Care n=49 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
28-day Mortality	1 participants	5 participants

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Days that a participant spent at the hospital. Multiple hospitalizations are summed up.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Hospitalization	6 days Interval 4.0 to 16.0	11 days Interval 5.0 to 25.0

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Number of ICU Admissions 1 ICU admission	40 participants	38 participants
Number of ICU Admissions 2 ICU admissions	2 participants	5 participants
Number of ICU Admissions 4 ICU admissions	0 participants	2 participants

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Days that a participant spent in ICU. Multiple ICU admissions are summed up.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Stay in ICU	2.5 days Interval 0.0 to 9.0	3 days Interval 0.0 to 13.0

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Time (in days) of supplemental oxygen use

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Days on Supplemental Oxygen	7 days Interval 1.0 to 28.0	8 days Interval 3.0 to 28.0

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Duration of supplemental oxygen use in days

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Supplemental Oxygen	7 days Interval 1.0 to 28.0	8 days Interval 3.0 to 28.0

SECONDARY outcome

Timeframe: Measured at Days 0, 1, 2, 4, 7, 14, 28

Population: 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.

Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=28 Participants 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	Standard Care n=26 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Incidence of Acute Respiratory Distress Syndrome (ARDS) Present	0 participants	3 participants

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Time (in days) of mechanical ventilation use

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Days on Mechanical Ventilation	0 days Interval 0.0 to 6.0	3 days Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Mechanical Ventilation	0 days Interval 0.0 to 6.0	3 days Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

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".

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=42 Participants 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	Standard Care n=45 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Disposition Following Initial Hospitalization released home - home health care not required	21 participants	17 participants
Disposition Following Initial Hospitalization released home with home health care	9 participants	6 participants
Disposition Following Initial Hospitalization transferred to long-term care facility	4 participants	6 participants
Disposition Following Initial Hospitalization hospitalization ongoing at Day 28	7 participants	9 participants
Disposition Following Initial Hospitalization deceased	1 participants	5 participants

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Plasma and Standard Care n=27 Participants 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	Standard Care n=35 Participants Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs	1 days Interval 1.0 to 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.	1 days Interval 1.0 to 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.

SECONDARY outcome

Timeframe: Measured through to Day 28

Population: 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.

Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured through Day 28

Incidence and duration of pre-term labor (defined as labor occurring \< 36 weeks) for pregnant female participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured from Day 0 through Day 28

Incidence of spontaneous abortion or stillborn fetus for pregnant female participants

Outcome measures

Outcome data not reported

Adverse Events

Plasma and Standard Care

Serious events: 9 serious events

Other events: 36 other events

Deaths: 1 deaths

Standard Care

Serious events: 20 serious events

Other events: 29 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

John Beigel, M.D.

Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)

Phone: 301-451-9881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Plasma and Standard Care n=46 participants at risk 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	Standard Care n=52 participants at risk Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza
Investigations Blood glucose increased	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	11.5% 6/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Aspartate aminotransferase increased	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	9.6% 5/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood albumin decreased	8.7% 4/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	7.7% 4/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood creatinine increased	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	5.8% 3/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood uric acid increased	2.2% 1/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	7.7% 4/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Alanine aminotransferase increased	2.2% 1/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	7.7% 4/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood sodium decreased	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	3.8% 2/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Haemoglobin decreased	4.3% 2/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	5.8% 3/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood bilirubin increased	2.2% 1/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	5.8% 3/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood sodium increased	2.2% 1/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	5.8% 3/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Blood creatine phosphokinase increased	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	1.9% 1/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Investigations Lymphocyte count decreased	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	0.00% 0/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Respiratory, thoracic and mediastinal disorders Cough	17.4% 8/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	0.00% 0/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.7% 4/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	7.7% 4/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	7.7% 4/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Metabolism and nutrition disorders Hypokalaemia	13.0% 6/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	1.9% 1/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Metabolism and nutrition disorders Hypernatraemia	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	1.9% 1/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Metabolism and nutrition disorders Hyperglycaemia	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	3.8% 2/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Metabolism and nutrition disorders Alkalosis	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	0.00% 0/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Gastrointestinal disorders Diarrhoea	17.4% 8/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	3.8% 2/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Gastrointestinal disorders Nausea	13.0% 6/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	3.8% 2/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Gastrointestinal disorders Vomiting	0.00% 0/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	5.8% 3/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Gastrointestinal disorders Constipation	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	0.00% 0/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Blood and lymphatic system disorders Thrombocytopenia	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	9.6% 5/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Blood and lymphatic system disorders Anaemia	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	7.7% 4/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Blood and lymphatic system disorders Leukopenia	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	1.9% 1/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
General disorders Pyrexia	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	9.6% 5/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Nervous system disorders Headache	10.9% 5/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	3.8% 2/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.
Vascular disorders Hypotension	6.5% 3/46 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.	1.9% 1/52 • Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28 Adverse events were assessed by treatment received (as opposed to randomized treatment).The Participant Flow is presented by randomized treatment.