A Study to Evaluate the Efficacy and Safety of IV Peramiv... | NCT00958776

Name	Class
Department of Health and Human Services	FED

Label	Type	Description	Intervention Names
Peramivir+SOC	Experimental	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.	Drug: Peramivir+SOC
Placebo+SOC	Placebo Comparator	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.	Drug: Placebo+SOC

Name	Type	Description	Arm Group Labels	Other Names
Peramivir+SOC	Drug	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Clinical Resolution (Kaplan-Meier Estimate)	Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).	10 days

Secondary Outcomes

Measure	Description	Time Frame
Change (Reduction) in Influenza Virus Titer	The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.	Baseline and 24, 48, 108 hours
Time to Alleviation of Clinical Symptoms of Influenza

Other Outcomes

Measure	Description	Time Frame
Time to Hospital Discharge	Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.	10 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥12 years of age, male or female.
Able to provide informed consent, or for whom consent may be provided by guardian, unless informed consent provided by a guardian or a legally authorized representative is not consistent with applicable local or ethical concerns, procedures, directives and/or guidelines.
Subject must have at least one of the following clinical presentations at Screening:
1. Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR
2. Oxygen saturation <92%, OR
3. Two out of the following three vital signs:

Respiration rate >24/minute, Heart rate >100/minute, Systolic BP <90 mmHg

Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe).
Presence of at least one constitutional symptom (headache, myalgia, feverishness, or fatigue) of any severity (mild, moderate, or severe).
Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
Either:

Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care.

Presence of one or more of the following factors:

Age ≥60 years. Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy.

Current history of congestive heart failure or angina. Presence of diabetes mellitus, clinically stable or unstable. Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value (an investigative site at altitude >2000 ft above sea level will utilize different criteria for oxygen saturation).

History of chronic renal impairment not requiring peritoneal dialysis. Serum creatinine > 2.0 mg/dL or > 177 μmol/L.

Diagnosis of Influenza by satisfying one of the following:
1. Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive rapid antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit), or positive test (using other methodology) for influenza A and/or B virus antigen or RNA performed in a clinical laboratory at the screening/enrollment evaluation are eligible for enrollment.
  
  OR
2. Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT test may be enrolled once the site has been approved by the Sponsor to enroll such subjects, based on documentation of an outbreak of influenza in the community. An influenza outbreak may be documented in the catchment area of the hospital via one of the following methods: 1) local confirmation of influenza A or B infection in the current influenza season by a) the institution's local laboratory, or b) the local public health system, or c) the national public health system, or d) a laboratory of a recognized multinational influenza surveillance scheme such as the European Influenza Surveillance Network (EISN); 2) prior enrollment of a RAT positive subject into this study at the same institution in the current influenza season.
  
  Exclusion Criteria:
Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department).
Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir in the previous 7 days.
Blood platelet count of < 20 x 109/L at the time of the screening evaluation.
Serum bilirubin > 6 mg/dL or > 105 μmol/L at time of screening evaluation.
Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation.
Congestive heart failure of NYHA Class III or Class IV functional status.
Serum creatinine > 5.0 mg/dL or > 500 μmol/L at time of screening evaluation.
Subjects who require peritoneal dialysis.
Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding.
Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. Subjects who have completed treatment 30 days prior to enrollment are not excluded. Hormone treatment for cancer is also not excluded.
Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly active antiretroviral therapy (HAART) for at least 6 months.
Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). Subjects with chronic osteomyelitis or Hepatitis B or C not requiring treatment are not excluded.
Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
Previous treatment with intravenous or intramuscular peramivir.
Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation.
Subjects diagnosed with Cystic Fibrosis.
Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of screening evaluation.
Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

PubMed Identifier	Type	Citation	Retractions
25115871	Derived	de Jong MD, Ison MG, Monto AS, Metev H, Clark C, O'Neil B, Elder J, McCullough A, Collis P, Sheridan WP. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12.

ID	Title	Description
FG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
FG001	Peramivir+SOC

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00043(7 to 92) BG00147(6 to 92) BG00246(6 to 92)

Age, Customized

There were no subjects 6-11 years of age in the ITTI population.

Number

participants

Title

Denominators

Categories

Children 6-11 Years

Title	Measurements
	BG0002 BG0012 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00067 BG001132 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG00031 BG00152 BG002

Body mass index (BMI)

Mean

Full Range

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.7(15.2 to 59.9) BG00127.5(12.3 to 66.0) BG002

Supplemental oxygen required at Screening

Number

participants

Title

Denominators

Categories

Needed

Title	Measurements
	BG00045 BG00187 BG002

ICU admission at Baseline

Number

participants

Title

Denominators

Categories

Admitted

Title	Measurements
	BG00017 BG00133 BG002

Influenza Vaccination Status

Number

participants

Title

Denominators

Categories

Not vaccinated this year

Title	Measurements
	BG000111 BG001226 BG002

Duration of Illness

Number

participants

Title

Denominators

Categories

≤ 48 hours

Title	Measurements
	BG00075 BG001150 BG002

Standard of Care Received (CRF)

Number

participants

Title

Denominators

Categories

NAI-Containing Antiviral Therapy

Title	Measurements
	BG00089 BG001179 BG002

Absolute Lymphocyte Count at Baseline

Mean

Standard Deviation

cell count

Title

Denominators

Categories

Title	Measurements
	BG0001.3± 1.25 BG0011.3± 1.52 BG002

Chest X-ray at Screening

Number

participants

Title

Denominators

Categories

Normal

Title	Measurements
	BG00088 BG001148 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Clinical Resolution (Kaplan-Meier Estimate)

Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).

The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain a NAI at randomization.

Posted

Median

95% Confidence Interval

hours

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Units	Counts
Participants	OG00043 OG00178

Title

Denominators

Categories

Title	Measurements
	OG00049.5(40.0 to 61.9) OG00142.5(34.0 to 57.9)

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
OG000 OG001		Wilcoxon-Gehan statistic	Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.	0.973		Hazard Ratio (HR)	1.03			2-Sided	95	0.69	1.55			The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.	No	Superiority or Other

Secondary

Change (Reduction) in Influenza Virus Titer

The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.

Posted

Median

95% Confidence Interval

log10 viral particles/mL

Baseline and 24, 48, 108 hours

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Units

Secondary

Time to Alleviation of Clinical Symptoms of Influenza

Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.

Posted

Median

95% Confidence Interval

hours

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Secondary

Time to Resolution of Fever (Kaplan-Meier Estimate)

Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.

Posted

Median

95% Confidence Interval

hours

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Secondary

Time to Resumption of Usual Activities

Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.

Posted

Median

95% Confidence Interval

days

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Secondary

Number of Subjects With ICU Admission

The number of subjects requiring ICU admission post-randomization was summarized by treatment group.

Posted

Number

participants

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Units	Counts
Participants

Secondary

Duration of All ICU Admissions (Kaplan-Meier Estimate)

Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.

Posted

Median

95% Confidence Interval

days

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Other Pre-specified

Time to Hospital Discharge

Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.

Posted

Median

95% Confidence Interval

days

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Other Pre-specified

Incidence of Influenza-Related Complications

Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis, and pneumonia as reported on the influenza-related complications CRF.

Posted

Number

participants

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Units	Counts

Other Pre-specified

Number of Subjects Requiring More Than 5 Days of Study Drug

Subjects who had not met the protocol-defined criteria of clinical resolution on Day 5 or who had detectable virus by RT-PCR from a sample collected on Study Day 4 after dosing continued their assigned treatment for a further 5 days.

Posted

Number

participants

10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Units

Other Pre-specified

Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)

Survival was calculated as the number of days from initiation of study drug until death or last contact. Estimates and 95% confidence intervals were calculated using the method of Kaplan-Meier and presented by treatment group.

Posted

Number

95% Confidence Interval

Percent Survival

28 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Other Pre-specified

Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)

Initial viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.

The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.

Posted

Mean

Standard Deviation

Initial (baseline or post-baseline) and up to 10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Units

Other Pre-specified

Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial

Viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented as fold change from initial sensitivity by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.

The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.

Posted

Mean

Standard Deviation

fold change

Initial (baseline or post-baseline) and up to 10 days

ID	Title	Description
OG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
OG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0012 affected264 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected134 at risk EG0012 affected264 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected134 at risk EG0012 affected264 at risk
Klebsiella Bacteraemia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Sinusitis Bacterial	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected134 at risk EG0010 affected264 at risk
Echinococciasis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Influenza	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Septic Shock	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Viral Myositis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0012 affected264 at risk
Neuroleptic Malignant Syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Presyncope	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Confusional State	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Delirium	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Chest Pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Multi-organ Disorder	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected134 at risk EG0011 affected264 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Accidental Needle Stick	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk
Haemodynamic Instability	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0010 affected264 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected134 at risk EG00112 affected264 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected134 at risk EG00110 affected264 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected134 at risk EG0016 affected264 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected134 at risk EG0013 affected264 at risk
Insomnia	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG00110 affected264 at risk
Anxiety	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0015 affected264 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0005 affected134 at risk EG0017 affected264 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0017 affected264 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0016 affected264 at risk
Blood Glucose Increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0015 affected264 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected134 at risk EG0018 affected264 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0012 affected264 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0011 affected264 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected134 at risk EG0011 affected264 at risk
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected134 at risk EG0017 affected264 at risk
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0011 affected264 at risk
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected134 at risk EG0017 affected264 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected134 at risk EG0015 affected264 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected134 at risk EG0014 affected264 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		La Mesa	California		United States

ID	Term
D003371	Cough
D010612	Pharyngitis
D015508	Nasal Obstruction
D006261	Headache
D005334	Fever
D007251	Influenza, Human

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases
D010038	Otorhinolaryngologic Diseases
D009668	Nose Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency
D010146	Pain
D009461	Neurologic Manifestations
D001832	Body Temperature Changes
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

ID	Title	Description
BG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
BG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo+SOC	Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.			13	134	42	134
EG001	Peramivir+SOC	Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.			15	264	63	264