| Primary | Time to Normalization of Respiratory Status (Primary Efficacy Population) | Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| | | Title | Measurements |
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| - OG0007(2 to NA)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.
- OG00128(7 to NA)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.
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Log Rank | | 0.069 | | | | | | | | | | | | | | Superiority or Other | | |
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| Secondary | Time to Normalization of Respiratory Status (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. | All randomized participants | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Time to Resolution of Clinical Symptoms | 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. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Time to Resolution of Fever | Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Time to Resolution of All Symptoms and Fever | 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. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | 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 | 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. | 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. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | 50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time | 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. | 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. | Posted | | Number | | participants | | Measured at Days 1, 2, 4, 7, 14, 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | In-hospital Mortality | Number of deaths in hospital during initial hospital admission | All randomized participants | Posted | | Number | | participants | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | 28-day Mortality | Number of deaths during study follow-up | All randomized participants | Posted | | Number | | participants | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Hospitalization | Days that a participant spent at the hospital. Multiple hospitalizations are summed up. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Number of ICU Admissions | Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Number | | participants | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Stay in ICU | Days that a participant spent in ICU. Multiple ICU admissions are summed up. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Days on Supplemental Oxygen | Time (in days) of supplemental oxygen use | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Supplemental Oxygen | Duration of supplemental oxygen use in days | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Incidence of Acute Respiratory Distress Syndrome (ARDS) Present | Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0. | 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. | Posted | | Number | | participants | | Measured at Days 0, 1, 2, 4, 7, 14, 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Days on Mechanical Ventilation | Time (in days) of mechanical ventilation use | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Mechanical Ventilation | Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up. | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Disposition Following Initial Hospitalization | 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". | The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. | Posted | | Number | | participants | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs | 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) | 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. | Posted | | Median | Inter-Quartile Range | days | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women | Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants | 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. | Posted | | | | | | Measured through to Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women | Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants | 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. | Posted | | | | | | Measured through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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| Secondary | Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women | Incidence of spontaneous abortion or stillborn fetus for pregnant female participants | 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. | Posted | | | | | | Measured from Day 0 through Day 28 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Standard Care | Participants will receive standard care. Standard Care: Standard care for hospitalized people with influenza |
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