Trial Outcomes & Findings for Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A (NCT NCT03040141)

Results Overview

Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical status using a seven-level ordinal scale. Comparison between treatment groups and between all VIS410 recipients versus placebo were assessed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

7 days

Results posted on

2022-12-28

Participant Flow

Approximately 120 participants were planned however, a total of 89 subjects were randomized to treatment. 73 participants completed the trial. There were study discontinuations for death, consent withdrawn and participants who were enrolled, but did not receive study drug.

Participant milestones

Participant milestones
Measure	VIS410 High Dose VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	Placebo Single intravenous infusion of placebo in addition to oseltamivir
Overall Study STARTED	29	30	30
Overall Study COMPLETED	25	24	24
Overall Study NOT COMPLETED	4	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	VIS410 High Dose VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	Placebo Single intravenous infusion of placebo in addition to oseltamivir
Overall Study Death	1	2	3
Overall Study Withdrawal by Subject	3	1	1
Overall Study Subject discharged to nursing home, not able to attend visits	0	1	0
Overall Study Subject did not receive study drug or was not confirmed Influenza A positive	0	2	2

Baseline Characteristics

Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir	Total n=85 Participants Total of all reporting groups
Age, Continuous Age (years)	60 years STANDARD_DEVIATION 19.00 • n=5 Participants	66.2 years STANDARD_DEVIATION 13.94 • n=7 Participants	57.5 years STANDARD_DEVIATION 22.41 • n=5 Participants	61.2 years STANDARD_DEVIATION 18.91 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	00 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	28 Participants n=7 Participants	24 Participants n=5 Participants	79 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	61 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment Singapore	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Malaysia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Belarus	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Thailand	3 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	11 participants n=4 Participants
Region of Enrollment Spain	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Latvia	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment South Africa	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Georgia	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Bulgaria	3 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment France	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Serbia	6 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants
Region of Enrollment Australia	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Estonia	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	9 participants n=4 Participants
Body mass index (kg/m^2)	28.2 Kg/m^2 STANDARD_DEVIATION 6.48 • n=5 Participants	28.4 Kg/m^2 STANDARD_DEVIATION 7.93 • n=7 Participants	29.2 Kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants	28.6 Kg/m^2 STANDARD_DEVIATION 6.87 • n=4 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Modified Intent to treat (MITT) population. All participants of the safety population that have an assessment of O2 support after randomization and are confirmed influenza A positive. Participants will be analyzed based on the treatment to which they were randomized, irrespective of what they actually received. This population was selected for the analysis of the primary endpoint to maintain the benefits of randomization and avoid the bias associated with the non-random loss of the participants

Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical status using a seven-level ordinal scale. Comparison between treatment groups and between all VIS410 recipients versus placebo were assessed.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Clinical Status of Participants on Day 7 Non-ICU hospitalization without supplemental oxygen	12 Participants	8 Participants	20 Participants	10 Participants
Clinical Status of Participants on Day 7 Death	1 Participants	1 Participants	2 Participants	1 Participants
Clinical Status of Participants on Day 7 ICU stay with mechanical ventilation	1 Participants	2 Participants	3 Participants	1 Participants
Clinical Status of Participants on Day 7 ICU stay without mechanical ventilation	2 Participants	0 Participants	2 Participants	0 Participants
Clinical Status of Participants on Day 7 Non-ICU hospitalization with supplemental oxygen	5 Participants	5 Participants	10 Participants	3 Participants
Clinical Status of Participants on Day 7 Discharge with partial resumption of normal activities	7 Participants	5 Participants	12 Participants	11 Participants
Clinical Status of Participants on Day 7 Discharge with full resumption of normal activities	1 Participants	7 Participants	8 Participants	2 Participants

PRIMARY outcome

Timeframe: 56 days

Population: Safety Population: Included all ITT participants (participants who randomized to treatment) who received IV study drug. Participants were grouped according to the actual treatment received.

Safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized participants with influenza A infection. Data presents the count of participants who experienced an adverse event (AE) or serious treatment emergent adverse events (TEAE).

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=30 Participants Single intravenous infusion of placebo in addition to oseltamivir
The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410 Participants with adverse events	16 Participants	22 Participants	38 Participants	16 Participants
The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410 Participants with at least one serious treatment emergent adverse events	6 Participants	4 Participants	10 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to Day 56

Population: Modified intent to treat population (MITT), number of participants who had cessation of oxygen support.

Time to cessation of O2 support in patients with supplemental oxygen with baseline room air \<= 92%. Patients with treatment resulting in a stable SpO2 by pulse oximetry. Stable SpO2 is defined as two consecutive SpO2 values of \>92% on room air that are at least 8 hours apart.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=18 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=15 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=33 Participants Combined results from VIS410 high and low dose groups	Placebo n=15 Participants Single intravenous infusion of placebo in addition to oseltamivir
Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air <= 92%	92.5 Hours Interval 45.5 to 138.7	101.3 Hours Interval 26.9 to 114.6	97.3 Hours Interval 45.5 to 124.7	79.0 Hours Interval 41.7 to 103.2

SECONDARY outcome

Timeframe: Baseline to Day 56

Population: Modified intent to treat population (MITT), number of participants who had cessation of oxygen support. NE = not estimable.

Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=26 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=53 Participants Combined results from VIS410 high and low dose groups	Placebo n=25 Participants Single intravenous infusion of placebo in addition to oseltamivir
Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy	119.2 Hours Interval 82.3 to 257.0	129.7 Hours Interval 99.3 to Data are not estimable due to the insufficient number of participants with events for two main reasons. First measured baseline room air oxygen saturation was \>92% in some subjects and in others the subject was already on supplemental oxygen and a measurement on room air at baseline was not obtained.	124.7 Hours Interval 83.6 to Data are not estimable due to the insufficient number of participants with events for two main reasons. First measured baseline room air oxygen saturation was \>92% in some subjects and in others the subject was already on supplemental oxygen and a measurement on room air at baseline was not obtained.	112.2 Hours Interval 74.2 to Data are not estimable due to the insufficient number of participants with events for two main reasons. First measured baseline room air oxygen saturation was \>92% in some subjects and in others the subject was already on supplemental oxygen and a measurement on room air at baseline was not obtained.

SECONDARY outcome

Timeframe: Day 14

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment. All efficacy analyses including the primary efficacy analyses were performed in the MITT population

The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Viral Titer in Upper Respiratory Samples by qRT-PCR	6.479 log10 virus particles/mL Standard Deviation 1.3860	6.378 log10 virus particles/mL Standard Deviation 1.1320	6.429 log10 virus particles/mL Standard Deviation 1.2544	6.169 log10 virus particles/mL Standard Deviation 1.2489

SECONDARY outcome

Timeframe: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 5.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Viral Nasopharyngeal AUC	18.329 Day*Log10 virus particles/ mL Standard Deviation 6.7272	15.999 Day*Log10 virus particles/ mL Standard Deviation 4.9232	17.164 Day*Log10 virus particles/ mL Standard Deviation 5.9559	17.727 Day*Log10 virus particles/ mL Standard Deviation 5.9824

SECONDARY outcome

Timeframe: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 7.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=27 Participants Single intravenous infusion of placebo in addition to oseltamivir
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7	25.490 Day*vp/mL Standard Deviation 9.0440	22.394 Day*vp/mL Standard Deviation 7.9006	23.942 Day*vp/mL Standard Deviation 8.5550	24.337 Day*vp/mL Standard Deviation 8.8837

SECONDARY outcome

Timeframe: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, Day 14

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 14.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=26 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=26 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=52 Participants Combined results from VIS410 high and low dose groups	Placebo n=25 Participants Single intravenous infusion of placebo in addition to oseltamivir
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14	37.356 Day*vp/mL Standard Deviation 17.6513	35.172 Day*vp/mL Standard Deviation 18.6217	36.264 Day*vp/mL Standard Deviation 17.9980	36.668 Day*vp/mL Standard Deviation 17.2015

SECONDARY outcome

Timeframe: 14 days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 14 (quantitative reverse-transcription polymerase chain reaction - qRT-PCR)

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion	13.5 Days Interval 8.0 to 14.7	12.7 Days Interval 5.9 to 13.7	12.7 Days Interval 10.7 to 13.7	11.9 Days Interval 6.5 to 13.7

SECONDARY outcome

Timeframe: 14 days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Number of participants in whom peak viral load is observed post-baseline based on quantitative reverse-transcription polymerase chain reaction (qRT-PCR). Post-baseline was considered the day 3 sample or later.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR	5 Participants	1 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 7

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Peak viral load based on TCID50 from nasopharyngeal swabs

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Peak Viral Load by TCID50	3.047 log10 TCID50/mL Standard Deviation 2.1651	2.714 log10 TCID50/mL Standard Deviation 1.7415	2.881 log10 TCID50/mL Standard Deviation 1.9534	2.604 log10 TCID50/mL Standard Deviation 2.0278

SECONDARY outcome

Timeframe: 56 days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Number of participants in whom peak viral load occurred post-baseline measured by TCID50. Post-baseline was considered the day 3 sample or later.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50	1 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 5 measured by TCID50 from nasopharyngeal swabs.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Viral Nasopharyngeal AUC by TCID50	3.826 Day*TCID50 log10/ml Standard Deviation 4.2581	2.823 Day*TCID50 log10/ml Standard Deviation 2.4121	3.324 Day*TCID50 log10/ml Standard Deviation 3.4649	3.519 Day*TCID50 log10/ml Standard Deviation 3.5317

SECONDARY outcome

Timeframe: 7 days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 7 measured by TCID50 from nasopharyngeal swabs.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=27 Participants Single intravenous infusion of placebo in addition to oseltamivir
Viral Nasopharyngeal AUC by TCID50	4.140 Day*TCID50 log10/ml Standard Deviation 5.2238	2.886 Day*TCID50 log10/ml Standard Deviation 2.5260	3.513 Day*TCID50 log10/ml Standard Deviation 4.1131	3.711 Day*TCID50 log10/ml Standard Deviation 4.2207

SECONDARY outcome

Timeframe: Nominal days 3, 5, 7

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.

Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Negative Viral Cultures by Study Day Participants with negative viral cultures by Day 3.	23 Participants	24 Participants	47 Participants	19 Participants
Negative Viral Cultures by Study Day Participants with negative viral cultures by Day 5.	25 Participants	26 Participants	51 Participants	25 Participants
Negative Viral Cultures by Study Day Participants with negative viral cultures by Day 7.	28 Participants	27 Participants	55 Participants	27 Participants

SECONDARY outcome

Timeframe: 7 Days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by TCID50 in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.

Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=27 Participants Single intravenous infusion of placebo in addition to oseltamivir
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion	1.7 Days Interval 0.6 to 1.9	1.7 Days Interval 1.5 to 1.8	1.7 Days Interval 1.6 to 1.7	1.8 Days Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 7 Days

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by TCID50 in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.

Number of days from the onset of symptoms until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=54 Participants Combined results from VIS410 high and low dose groups	Placebo n=27 Participants Single intravenous infusion of placebo in addition to oseltamivir
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms	4.7 Days Interval 3.6 to 5.3	4.8 Days Interval 3.9 to 5.1	4.8 Days Interval 4.1 to 4.9	4.4 Days Interval 4.0 to 5.7

SECONDARY outcome

Timeframe: Day 56

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Median time to clinical response defined by resolution of at least 4 of 5 vital signs: * Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C) * Oxygen saturation ≥ 95% on room air without support or a return to preinfection status, if pre-infection status was \< 95% * Pulse rate ≤ 100/min * Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use * Respiratory rate ≤ 24 beats per minute

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=56 Participants Combined results from VIS410 high and low dose groups	Placebo n=26 Participants Single intravenous infusion of placebo in addition to oseltamivir
Time to Clinical Response (4 Out of 5 Vital Signs)	2.6 hours Interval 2.2 to 21.9	2.6 hours Interval 2.2 to 24.0	2.6 hours Interval 2.2 to 21.9	2.8 hours Interval 2.2 to 44.2

SECONDARY outcome

Timeframe: Day 56

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Median time to clinical response defined by resolution of at all 5 vital signs: * Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C) * Oxygen saturation ≥ 95% on room air without support or a return to pre-infection status, if pre-infection status was \< 95% * Pulse rate ≤ 100/min * Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use * Respiratory rate ≤ 24 beats per minute

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=25 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=24 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=49 Participants Combined results from VIS410 high and low dose groups	Placebo n=22 Participants Single intravenous infusion of placebo in addition to oseltamivir
Time to Complete Clinical Response (Resolution of All Vital Signs)	103.0 hours Interval 45.4 to 170.6	114.6 hours Interval 47.5 to 166.1	103.0 hours Interval 47.5 to 170.6	99.8 hours Interval 63.0 to 168.5

SECONDARY outcome

Timeframe: Baseline to Day 7

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment

Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 7. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 7 to 49.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7	23.6 day*units on a scale Standard Deviation 5.55	22.4 day*units on a scale Standard Deviation 7.47	23.0 day*units on a scale Standard Deviation 6.53	21.4 day*units on a scale Standard Deviation 4.97

SECONDARY outcome

Timeframe: Baseline to Days 14

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment

Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 14. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 14 to 98.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.	40.3 day*units on a scale Standard Deviation 15.21	38.2 day*units on a scale Standard Deviation 18.73	39.3 day*units on a scale Standard Deviation 16.91	35.8 day*units on a scale Standard Deviation 12.54

SECONDARY outcome

Timeframe: Day 14

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Summary of Clinical Outcome on Seven-Level Ordinal Scale through Day 14. Worst post-baseline assessment observed. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Comparison of Clinical Status on Seven-level Ordinal Scale Scores ICU stay without mechanical ventilation	4 Participants	5 Participants	9 Participants	3 Participants
Comparison of Clinical Status on Seven-level Ordinal Scale Scores Non-ICU hospitalization without supplemental oxygen	2 Participants	1 Participants	3 Participants	2 Participants
Comparison of Clinical Status on Seven-level Ordinal Scale Scores Discharge with partial resumption of normal activities	0 Participants	1 Participants	1 Participants	0 Participants
Comparison of Clinical Status on Seven-level Ordinal Scale Scores Discharge with full resumption of normal activities	0 Participants	0 Participants	0 Participants	0 Participants
Comparison of Clinical Status on Seven-level Ordinal Scale Scores Death	1 Participants	2 Participants	3 Participants	1 Participants
Comparison of Clinical Status on Seven-level Ordinal Scale Scores ICU stay with mechanical ventilation	4 Participants	2 Participants	6 Participants	2 Participants
Comparison of Clinical Status on Seven-level Ordinal Scale Scores Non-ICU hospitalization with supplemental oxygen	18 Participants	17 Participants	35 Participants	20 Participants

SECONDARY outcome

Timeframe: 56 days

Population: Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=5 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=3 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=8 Participants Combined results from VIS410 high and low dose groups	Placebo n=3 Participants Single intravenous infusion of placebo in addition to oseltamivir
Total Number of Days on Ventilation	5.2 days Standard Deviation 4.55	7.0 days Standard Deviation 5.20	5.9 days Standard Deviation 4.52	11.7 days Standard Deviation 7.51

SECONDARY outcome

Timeframe: 56 days

Population: Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Total number of days on ventilation for participations who used ventilation, including participants on ventilation at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, "\<= 4 Seven-Level Ordinal Scale Score" is better; "\> 4 Seven-Level Ordinal Scale Score" is worse group. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=5 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=3 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=8 Participants Combined results from VIS410 high and low dose groups	Placebo n=3 Participants Single intravenous infusion of placebo in addition to oseltamivir
Comparison of Ordinal Scale Parameters - Days on Ventilation > 4 Seven-Level Ordinal Scale Score	5.2 days Standard Deviation 4.55	7.0 days Standard Deviation 5.2	5.9 days Standard Deviation 4.52	8.0 days Standard Deviation 5.66
Comparison of Ordinal Scale Parameters - Days on Ventilation <= 4 Seven-Level Ordinal Scale Score	—	—	—	19.0 days Standard Deviation NA There is only 1 participant analyzed.

SECONDARY outcome

Timeframe: 56 days

Population: Participants admitted to the ICU from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=11 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=10 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=21 Participants Combined results from VIS410 high and low dose groups	Placebo n=5 Participants Single intravenous infusion of placebo in addition to oseltamivir
Total Number of Days in ICU	8.5 days Standard Deviation 7.43	6.8 days Standard Deviation 3.71	7.7 days Standard Deviation 5.88	14.0 days Standard Deviation 9.38

SECONDARY outcome

Timeframe: 56 days

Population: Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Total number of days in intensive care for participants who admitted to ICU, including participants in ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, "\<= 4 Seven-Level Ordinal Scale Score" is better; "\> 4 Seven-Level Ordinal Scale Score" is worse group. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=11 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=10 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=21 Participants Combined results from VIS410 high and low dose groups	Placebo n=5 Participants Single intravenous infusion of placebo in addition to oseltamivir
Comparison of Ordinal Scale Parameters - Days in ICU > 4 Seven-Level Ordinal Scale Score	8.5 days Standard Deviation 7.43	6.8 days Standard Deviation 3.71	7.7 days Standard Deviation 5.88	10.8 days Standard Deviation 6.85
Comparison of Ordinal Scale Parameters - Days in ICU <= 4 Seven-Level Ordinal Scale Score" is better	—	—	—	27.0 days Standard Deviation NA There is only 1 participant analyzed.

SECONDARY outcome

Timeframe: Day 56

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Number of days until resumption of usual activities by treatment group

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Number of Days to Resumption of Usual Activities	11.9 days Standard Deviation 3.07	10.3 days Standard Deviation 4.10	11.1 days Standard Deviation 3.67	11.5 days Standard Deviation 3.38

SECONDARY outcome

Timeframe: Day 14

Population: The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.

Number of patients experiencing all-cause and attributable mortality rates at Day 14. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=58 Participants Combined results from VIS410 high and low dose groups	Placebo n=30 Participants Single intravenous infusion of placebo in addition to oseltamivir
All Cause and Attributable Mortality at Day 14 All-cause mortality Day 14	1 participants	2 participants	3 participants	1 participants
All Cause and Attributable Mortality at Day 14 Attributable mortality Day 14	1 participants	2 participants	3 participants	1 participants

SECONDARY outcome

Timeframe: Day 28

Population: The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.

Number of patients experiencing all-cause and attributable mortality by Day 28. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=58 Participants Combined results from VIS410 high and low dose groups	Placebo n=30 Participants Single intravenous infusion of placebo in addition to oseltamivir
All Cause and Attributable Mortality by Day 28 All-cause mortality Day 28	1 participants	2 participants	3 participants	2 participants
All Cause and Attributable Mortality by Day 28 Attributable mortality Day 28	1 participants	2 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: Day 56

Population: The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.

Number of patients experiencing all-cause and attributable mortality by Day 56. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=58 Participants Combined results from VIS410 high and low dose groups	Placebo n=30 Participants Single intravenous infusion of placebo in addition to oseltamivir
All Cause and Attributable Mortality Day 56 All-cause mortality Day 56	1 participants	2 participants	3 participants	2 participants
All Cause and Attributable Mortality Day 56 Attributable mortality Day 56	1 participants	2 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: Day 56

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Total number of days in hospital and/or ICU from admission to discharge

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Healthcare Resource Utilization. Days in Hospital and/or ICU	11.4 Days Standard Deviation 8.6	9.6 Days Standard Deviation 7.02	10.5 Days Standard Deviation 7.84	9.6 Days Standard Deviation 6.38

SECONDARY outcome

Timeframe: 56 days

Population: Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Total number of days in hospital or intensive care for participations who were admitted to Hospital/ICU, including participants in Hospital/ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, "\<= 4 Seven-Level Ordinal Scale Score" is better; "\> 4 Seven-Level Ordinal Scale Score" is worse group. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Comparison of Ordinal Scale Parameters - Days in Hospital/ICU <= 4 Seven-Level Ordinal Scale Score	8.6 days Standard Deviation 3.01	7.9 days Standard Deviation 5.13	8.3 days Standard Deviation 4.16	8.9 days Standard Deviation 5.64
Comparison of Ordinal Scale Parameters - Days in Hospital/ICU > 4 Seven-Level Ordinal Scale Score	15.9 days Standard Deviation 12.47	12.6 days Standard Deviation 9.08	14.3 days Standard Deviation 10.85	13.8 days Standard Deviation 9.74

SECONDARY outcome

Timeframe: Day 56

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Number of participants with rehospitalization due to influenza A relapse

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Number of Participants With Rehospitalization Due to Relapse Rehospitalization due to relapse--Yes	2 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Rehospitalization Due to Relapse Rehospitalization due to relapse--No	27 Participants	27 Participants	54 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 56

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Summary of influenza symptom complications, including baseline and incident complications

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=29 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=57 Participants Combined results from VIS410 high and low dose groups	Placebo n=28 Participants Single intravenous infusion of placebo in addition to oseltamivir
Number of Participants With Influenza-related Complications Other chronic pulmonary disease	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Influenza-related Complications Participants with at least 1 complication of Influenza	4 Participants	4 Participants	8 Participants	4 Participants
Number of Participants With Influenza-related Complications Participants with pneumonia	3 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Influenza-related Complications Participants with sinusitis	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Influenza-related Complications Death	1 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Influenza-related Complications Bacterial pneumonia	3 Participants	1 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56

Population: The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.

Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=28 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total Combined results from VIS410 high and low dose groups	Placebo Single intravenous infusion of placebo in addition to oseltamivir
The Maximum Concentration (Cmax) of VIS410 in Participant's Serum	1301.037 µg/mL Standard Deviation 241.0838	786.393 µg/mL Standard Deviation 202.7963	—	—

SECONDARY outcome

Timeframe: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56

Population: The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.

Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the area under the concentration/time curve from 0 to infinity (AUC0-inf) of VIS410 in participant's serum.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=23 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total Combined results from VIS410 high and low dose groups	Placebo Single intravenous infusion of placebo in addition to oseltamivir
The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum	11326.522 day*µg/mL Standard Deviation 4205.1144	6934.815 day*µg/mL Standard Deviation 2304.3093	—	—

SECONDARY outcome

Timeframe: PK samples were collected on days 1, 5, 14, 28 and 56.

Population: The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.

Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=23 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total Combined results from VIS410 high and low dose groups	Placebo Single intravenous infusion of placebo in addition to oseltamivir
The Clearance Rate (Cl) of VIS410 in Participant's Serum	401.652 mL/day Standard Deviation 143.6763	325.926 mL/day Standard Deviation 137.6743	—	—

SECONDARY outcome

Timeframe: PK samples were collected on days 1, 5, 14, 28 and 56.

Population: The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.

Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=23 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=27 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total Combined results from VIS410 high and low dose groups	Placebo Single intravenous infusion of placebo in addition to oseltamivir
The Half-life of VIS410 in Participant's Serum	9.407 mL/day Standard Deviation 3.5549	9.839 mL/day Standard Deviation 3.2465	—	—

SECONDARY outcome

Timeframe: From anti-VIS410 antibody samples collected on days 28 and 56.

Population: The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.

Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.

Outcome measures

Outcome measures
Measure	VIS410 High Dose n=25 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=26 Participants VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	VIS410 Total n=51 Participants Combined results from VIS410 high and low dose groups	Placebo n=25 Participants Single intravenous infusion of placebo in addition to oseltamivir
Anti-VIS410 Antibody Testing 1 to 4 fold	22 Participants	24 Participants	46 Participants	25 Participants
Anti-VIS410 Antibody Testing >4 to 16 fold	2 Participants	1 Participants	3 Participants	0 Participants
Anti-VIS410 Antibody Testing >16 to 64 fold	1 Participants	0 Participants	1 Participants	0 Participants
Anti-VIS410 Antibody Testing >64 fold	0 Participants	1 Participants	1 Participants	0 Participants

Adverse Events

VIS410 High Dose

Serious events: 7 serious events

Other events: 11 other events

Deaths: 1 deaths

VIS410 Low Dose

Serious events: 6 serious events

Other events: 13 other events

Deaths: 2 deaths

Total VIS410

Serious events: 13 serious events

Other events: 24 other events

Deaths: 3 deaths

Placebo

Serious events: 9 serious events

Other events: 7 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	VIS410 High Dose n=29 participants at risk VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir	VIS410 Low Dose n=29 participants at risk VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir	Total VIS410 n=58 participants at risk Combined results from VIS410 high and low dose groups.	Placebo n=30 participants at risk Single intravenous infusion of placebo in addition to oseltamivir
Blood and lymphatic system disorders Anaemia	10.3% 3/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	5.2% 3/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Gastrointestinal disorders Diarrhoea	17.2% 5/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	13.8% 4/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	15.5% 9/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Gastrointestinal disorders Dyspepsia	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.4% 2/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Gastrointestinal disorders Nausea	13.8% 4/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	10.3% 6/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.3% 1/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Gastrointestinal disorders Vomiting	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.4% 2/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.7% 2/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Infections and infestations Pneumonia	10.3% 3/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.4% 1/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.9% 4/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.3% 1/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	10.3% 3/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	5.2% 3/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.3% 1/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Metabolism and nutrition disorders Hypokalaemia	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.4% 1/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	5.2% 3/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.3% 1/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Metabolism and nutrition disorders Hypomagnesaemia	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.4% 2/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Renal and urinary disorders Haematuria	0.00% 0/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	3.4% 2/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	0.00% 0/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.4% 1/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	10.3% 3/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.9% 4/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.7% 2/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.
Vascular disorders Hypertension	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.9% 2/29 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	6.9% 4/58 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.	10.0% 3/30 • Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo. Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.

Additional Information

Head of Regulatory Affairs

Visterra Inc.

Phone: +1 617-498-1070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The institution may not publish study results until publication of the results of the full study or 2 years after study completion. The institution must provide a copy of any proposed publication to the Sponsor at least 40 days in advance The Sponsor may: 1. provide comments on the proposed publication; 2. request delay of the publication for 120 days; 3. request that specified confidential information be removed
Publication restrictions are in place

Restriction type: OTHER