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CompletedNCT02293863Updated Jun 18, 2018Results posted

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

A Phase 2 interventional study of MHAA4549A and Oseltamivir in Influenza, sponsored by Genentech, Inc.. Completed at 171 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-18.

Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

02

Conditions studied

  • Influenza

Browse trials for

03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 168 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of influenza A where a Sponsor-approved influenza test is used as an aid in diagnosis. A Sponsor-approved influenza test includes: Influenza antigen test or Influenza polymerase chain reaction (PCR) test
  • One of the following markers of severity within 24 hours of admission: requirement for O2 supplementation to maintain SpO2 greater than (>) 92 %; or requirement for Positive Pressure Ventilation (PPV)
  • A negative urine or serum pregnancy test for women of childbearing potential within 2 days prior to study treatment
  • Participants of reproductive potential must agree to use acceptable contraceptive measures as per the protocol as a minimum, and local guidelines, if more stringent

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women, or women who intend to become pregnant during the study
  • Hypersensitivity to monoclonal antibodies or any constituents (sodium succinate, sucrose, polysorbate 20) of study drug
  • Hypersensitivity to the active substance or to any excipients of oseltamivir
  • Investigational therapy within the 30 days prior to study treatment
  • Received prior therapy with any anti-influenza monoclonal antibody therapy (including MHAA4549A) within 8 months prior to study treatment
  • Current treatment (within 7 days of dosing) with probenecid, amantadine or rimantidine
  • Participants who have taken more than a total of 6 doses (3 doses for peramivir) of anti-influenza therapy (e.g., oseltamivir, zanamivir, laninamivir, peramivir) in the period from onset of symptoms and prior to study treatment
  • Admission >48 hours prior to study treatment
  • Onset of influenza symptoms (including fever, chills, malaise, dry cough, loss of appetite, myalgias, coryza, or nausea) >5 days prior to study treatment
  • Positive influenza B or influenza A + B infection within 2 weeks prior to study treatment
  • High probability of mortality in the next 48 hours as determined by the investigator
  • Participants requiring home or baseline oxygenation therapy
  • Participants with history of chronic lung disease with a documented SpO2 less than (\<) 95% off oxygen
  • Participants on chronic dose of corticosteroids exceeding 10 milligrams per day (mg/day) of prednisone or equivalent steroid dose for duration of greater than 14 days within 30 days of entry into study
  • Participants with the following significant immune suppression: bone marrow or solid organ transplant in the previous 12 months; cancer chemotherapy in the previous 12 months, HIV infection with most recent Cluster of Differentiation 4 (CD4) \<200 cells per milliliter (cells/mL), or other significant immune suppression as determined by the investigator in discussion with the Sponsor Medical Monitor
  • Participants on extracorporeal membrane oxygenation (ECMO) at time of randomization
  • Any disease or condition that would, in the opinion of the site investigator or Sponsor, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    A: MHAA4549A 3600 mg + Oseltamivir

    Participants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.

    Drug: MHAA4549A · Drug: Oseltamivir

  • Experimental
    B: MHAA4549A 8400 mg + Oseltamivir

    Participants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.

    Drug: MHAA4549A · Drug: Oseltamivir

  • Placebo comparator
    C: Placebo + Oseltamivir

    Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy (75 or 150 mg BID) for minimum of 5 days.

    Drug: Oseltamivir · Drug: Placebo

Interventions

  • DrugMHAA4549A

    Participants will receive a single dose of MHAA4549A by IV infusion on Day 1

  • DrugOseltamivir

    Participants will receive oseltamivir capsule either 75 mg or 150 mg BID orally for minimum of 5 days. Dosage and administration should follow local prescribing information for oseltamivir.

    Also known as: Tamiflu

  • DrugPlacebo

    Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Time frame: From randomization up to 60 days

  2. Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A

    Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.

    Time frame: From randomization up to 60 days

  3. Time to Normalization of Respiratory Function

    The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.

    Time frame: From randomization up to 60 days

Secondary outcomes

  1. Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome

    The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.

    Time frame: Days 1-7, 14 and 30

  2. Percentage of Participants With Clinical Failure

    Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2-6 liters per minute \[L/min\]) to high flow oxygen (i.e., \> 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by \> 2 weeks, or death.

    Time frame: 24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60

  3. Percentage of Participants With Clinical Resolution of Abnormal Vital Signs

    Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate \< 24 breaths per minute without supplemental O2; 3. Core temperature \< 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature \> 36 C in participants who are initially hypothermic; 4. Heart rate (HR) \< 100 beats/minute; 5. Systolic blood pressure (SBP) \>90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.

    Time frame: From randomization up to 60 days

  4. Percentage of Participants Who Died Due to Any Cause

    Time frame: Days 14, 30 and 60

  5. Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus

    Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).

    Time frame: Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)

  6. Peak Influenza A Viral Load

    Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.

    Time frame: Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)

  7. Duration of Viral Shedding

    Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.

    Time frame: Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)

  8. Duration of Hospitalization

    Time frame: From randomization up to 60 days

  9. Duration of Intensive Care Unit (ICU) Stay

    Time frame: From randomization up to 60 days

  10. Percentage of Participants Using Antibiotics for Respiratory Infections

    Time frame: From randomization up to 60 days

  11. Percentage of Participants With Secondary Complications of Influenza

    The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.

    Time frame: From randomization up to 60 days

  12. Percentage of Participants Readmitted to Hospital Due to Any Cause

    Time frame: Days 30 and 60

  13. Duration of Ventilation

    Time frame: From randomization up to 60 days

  14. Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A

    AUC0-inf is reported as day\*microgram/milliliter (day\*mcg/mL).

    Time frame: 30 minutes (min) before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  15. Maximum Serum Concentration (Cmax ) of MHAA4549A

    Time frame: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  16. Elimination Half-Life (Terminal t1/2) of MHAA4549A

    Time frame: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  17. Observed Clearance (CL-obs) of MHAA4549A

    Time frame: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

  18. Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A

    Time frame: 30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

07

Results

Posted Jun 18, 2018

Participant flow

Enrolled in the study were 168 participants. The participant flow is reported for the safety population (158 participants), which included all randomized participants who received study drug, with participants grouped according to the treatment actually received.

Participant flow — Overall Study
MilestonePlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Started565547
Completed474238
Not completed9139
Withdrew: Death464
Withdrew: Lost to follow-up222
Withdrew: Withdrawal by subject331
Withdrew: Reason not specified022

Outcome measures

PrimaryPercentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Time frame:
From randomization up to 60 days
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Percentage of Participants With Adverse Events80.467.374.5
PrimaryNumber of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A

Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.

Time frame:
From randomization up to 60 days
Reported as:
Number · participants
Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A
participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Positive for ATAs at baseline011
Treatment-induced ATAs000
Treatment-enhanced ATAs000
PrimaryTime to Normalization of Respiratory Function

The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.

Time frame:
From randomization up to 60 days
Reported as:
Median · days
Time to Normalization of Respiratory Function
daysPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Time to Normalization of Respiratory Function4.28 (3.06 to 6.60)2.78 (2.52 to 4.20)2.65 (1.58 to 4.52)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.6050 · Hazard ratio (hr): 1.08 · 80% CI 0.83 to 1.40
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.2028 · Hazard ratio (hr): 1.13 · 80% CI 0.85 to 1.51
SecondaryPercentage of Participants by Clinical Status Using a Categorical Ordinal Outcome

The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.

Time frame:
Days 1-7, 14 and 30
Reported as:
Number · percentage of participants
Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Day 1: Death0.00.00.0
Day 1: In ICU42.638.543.2
Day 1: Non-ICU, requiring supplemental O257.461.552.3
Day 1: Non-ICU, not requiring supplemental O20.00.04.5
Day 1: Not hospitalized0.00.00.0
Day 2: Death0.00.02.3
Day 2: In ICU42.638.538.6
Day 2: Non-ICU, requiring supplemental O240.751.931.8
Day 2: Non-ICU, not requiring supplemental O211.17.720.5
Day 2: Not hospitalized5.61.96.8
Day 3: Death0.00.02.3
Day 3: In ICU37.032.734.1
Day 3: Non-ICU, requiring supplemental O231.542.327.3
Day 3: Non-ICU, not requiring supplemental O220.419.225.0
Day 3: Not hospitalized11.15.811.4
Day 4: Death0.00.02.3
Day 4: In ICU35.230.829.5
Day 4: Non-ICU, requiring supplemental O225.921.218.2
Day 4: Non-ICU, not requiring supplemental O222.236.529.5
Day 4: Not hospitalized16.711.520.5
Day 5: Death0.00.02.3
Day 5: In ICU27.826.927.3
Day 5: Non-ICU, requiring supplemental O225.919.218.2
Day 5: Non-ICU, not requiring supplemental O224.134.627.3
Day 5: Not hospitalized22.219.225.0
Day 6: Death1.91.92.3
Day 6: In ICU22.223.122.7
Day 6: Non-ICU, requiring supplemental O222.215.415.9
Day 6: Non-ICU, not requiring supplemental O227.834.625.0
Day 6: Not hospitalized25.925.034.1
Day 7: Death1.91.92.3
Day 7: In ICU18.521.220.5
Day 7: Non-ICU, requiring supplemental O224.113.515.9
Day 7: Non-ICU, not requiring supplemental O214.828.825.0
Day 7: Not hospitalized40.734.636.4
Day 14: Death1.93.86.8
Day 14: In ICU5.611.59.1
Day 14: Non-ICU, requiring supplemental O27.43.86.8
Day 14: Non-ICU, not requiring supplemental O214.83.84.5
Day 14: Not hospitalized70.476.972.7
Day 30: Death5.67.79.1
Day 30: In ICU1.93.84.5
Day 30: Non-ICU, requiring supplemental O25.61.94.5
Day 30: Non-ICU, not requiring supplemental O21.93.80.0
Day 30: Not hospitalized85.282.781.8
SecondaryPercentage of Participants With Clinical Failure

Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2-6 liters per minute \[L/min\]) to high flow oxygen (i.e., \> 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by \> 2 weeks, or death.

Time frame:
24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Failure
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Percentage of Participants With Clinical Failure14.8 (8.82 to 22.95)25.0 (17.22 to 34.32)22.7 (14.63 to 32.84)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.1905 · Difference in event rates: 10.19 · 80% CI -0.15 to 20.52
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.3168 · Difference in event rates: 7.91 · 80% CI -2.64 to 18.47
SecondaryPercentage of Participants With Clinical Resolution of Abnormal Vital Signs

Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate \< 24 breaths per minute without supplemental O2; 3. Core temperature \< 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature \> 36 C in participants who are initially hypothermic; 4. Heart rate (HR) \< 100 beats/minute; 5. Systolic blood pressure (SBP) \>90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.

Time frame:
From randomization up to 60 days
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Resolution of Abnormal Vital Signs
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Percentage of Participants With Clinical Resolution of Abnormal Vital Signs81.3 (62.88 to 92.90)73.3 (53.60 to 87.82)66.7 (44.10 to 84.58)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.6043 · Difference in event rates: -7.92 · 80% CI -27.50 to 11.66
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.3865 · Difference in event rates: -14.58 · 80% CI -36.13 to 6.97
SecondaryPercentage of Participants Who Died Due to Any Cause
Time frame:
Days 14, 30 and 60
Reported as:
Number · percentage of participants
Percentage of Participants Who Died Due to Any Cause
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Day 141.9 (0.19 to 7.01)3.8 (1.03 to 9.91)6.8 (2.53 to 14.56)
Day 305.6 (2.06 to 11.95)7.7 (3.40 to 14.79)9.1 (4.02 to 17.35)
Day 607.4 (3.27 to 14.26)9.6 (4.75 to 17.11)9.1 (4.02 to 17.35)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.5379 · Difference in event rates: 1.99 · 80% CI -5.57 to 9.56
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.2189 · Difference in event rates: 4.97 · 80% CI -3.12 to 13.05
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.6594 · Difference in event rates: 2.14 · 80% CI -6.04 to 10.31
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.5013 · Difference in event rates: 3.54 · 80% CI -5.24 to 12.31
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.6849 · Difference in event rates: 2.21 · 80% CI -6.28 to 10.69
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.7633 · Difference in event rates: 1.68 · 80% CI -7.38 to 10.74
SecondaryArea Under Viral Load-Time Curve (AUEC ) of Influenza A Virus

Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).

Time frame:
Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)
Reported as:
Mean · log10 (vp/mL x hour).
Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus
log10 (vp/mL x hour).Placebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus25.72 ± 15.9221.99 ± 16.5725.03 ± 13.48
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · ANOVA · p = 0.2407 · Mean difference (final values): -3.73 · 80% CI -6.41 to -1.06
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · ANOVA · p = 0.8339 · Mean difference (final values): -0.70 · 80% CI -3.49 to 2.10
SecondaryPeak Influenza A Viral Load

Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.

Time frame:
Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)
Reported as:
Mean · log10 vp/mL
Peak Influenza A Viral Load
log10 vp/mLPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Peak Influenza A Viral Load5.70 ± 1.325.37 ± 1.395.28 ± 1.71
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · ANOVA · p = 0.2790 · Mean difference (final values): -0.33 · 80% CI -0.60 to -0.07
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · ANOVA · p = 0.1909 · Mean difference (final values): -0.42 · 80% CI -0.70 to -0.15
SecondaryDuration of Viral Shedding

Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.

Time frame:
Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)
Reported as:
Median · days
Duration of Viral Shedding
daysPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Duration of Viral Shedding4.00 (3.66 to 5.60)4.63 (3.63 to 4.97)4.60 (3.57 to 5.53)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.7413 · Hazard ratio (hr): 1.01 · 80% CI 0.77 to 1.32
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.4763 · Hazard ratio (hr): 1.32 · 80% CI 0.99 to 1.77
SecondaryDuration of Hospitalization
Time frame:
From randomization up to 60 days
Reported as:
Median · days
Duration of Hospitalization
daysPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Duration of Hospitalization8.95 (5.90 to 10.29)7.65 (6.94 to 8.02)6.69 (6.00 to 8.86)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.8806 · Hazard ratio (hr): 1.01 · 80% CI 0.78 to 1.32
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.5447 · Hazard ratio (hr): 1.05 · 80% CI 0.80 to 1.38
SecondaryDuration of Intensive Care Unit (ICU) Stay
Time frame:
From randomization up to 60 days
Reported as:
Median · days
Duration of Intensive Care Unit (ICU) Stay
daysPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Duration of Intensive Care Unit (ICU) Stay4.66 (3.91 to 7.10)6.60 (4.82 to 10.53)5.29 (3.25 to 6.58)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.4171 · Hazard ratio (hr): 0.70 · 80% CI 0.47 to 1.03
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.8322 · Hazard ratio (hr): 0.90 · 80% CI 0.61 to 1.34
SecondaryPercentage of Participants Using Antibiotics for Respiratory Infections
Time frame:
From randomization up to 60 days
Reported as:
Number · percentage of participants
Percentage of Participants Using Antibiotics for Respiratory Infections
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Percentage of Participants Using Antibiotics for Respiratory Infections13.0 (7.36 to 20.84)11.5 (6.17 to 19.37)11.4 (5.63 to 20.06)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.8240 · Difference in event rates: -1.42 · 80% CI -10.61 to 7.76
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.8111 · Difference in event rates: -1.60 · 80% CI -11.48 to 8.28
SecondaryPercentage of Participants With Secondary Complications of Influenza

The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.

Time frame:
From randomization up to 60 days
Reported as:
Number · percentage of participants
Percentage of Participants With Secondary Complications of Influenza
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Percentage of Participants With Secondary Complications of Influenza13.0 (7.36 to 20.84)15.4 (9.17 to 23.79)13.6 (7.32 to 22.71)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.7219 · Difference in event rates: 2.42 · 80% CI -6.96 to 11.80
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.9225 · Difference in event rates: 0.67 · 80% CI -9.29 to 10.64
SecondaryPercentage of Participants Readmitted to Hospital Due to Any Cause
Time frame:
Days 30 and 60
Reported as:
Number · percentage of participants
Percentage of Participants Readmitted to Hospital Due to Any Cause
percentage of participantsPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Percentage of Participants Readmitted to Hospital Due to Any Cause1.9 (0.19 to 7.01)3.8 (1.03 to 9.91)0 (0.00 to 5.10)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.5379 · Difference in event rates: 1.99 · 80% CI -5.57 to 9.56
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Cochran-Mantel-Haenszel · p = 0.3667 · Difference in event rates: -1.85 · 80% CI -9.88 to 6.18
SecondaryDuration of Ventilation
Time frame:
From randomization up to 60 days
Reported as:
Median · days
Duration of Ventilation
daysPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Duration of Ventilation4.11 (2.72 to 5.32)7.05 (1.92 to 13.12)5.89 (4.13 to 13.07)
Statistical analysis
  • Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.7827 · Hazard ratio (hr): 0.66 · 80% CI 0.41 to 1.07
  • Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir · Wilcoxon (Mann-Whitney) · p = 0.2522 · Hazard ratio (hr): 0.58 · 80% CI 0.36 to 0.96
SecondaryArea Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A

AUC0-inf is reported as day\*microgram/milliliter (day\*mcg/mL).

Time frame:
30 minutes (min) before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Reported as:
Mean · day*mcg/mL
Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A
day*mcg/mLMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A11400 ± 453026700 ± 9810
SecondaryMaximum Serum Concentration (Cmax ) of MHAA4549A
Time frame:
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Reported as:
Mean · mcg/mL
Maximum Serum Concentration (Cmax ) of MHAA4549A
mcg/mLMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Maximum Serum Concentration (Cmax ) of MHAA4549A916 ± 2942220 ± 556
SecondaryElimination Half-Life (Terminal t1/2) of MHAA4549A
Time frame:
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Reported as:
Mean · day
Elimination Half-Life (Terminal t1/2) of MHAA4549A
dayMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Elimination Half-Life (Terminal t1/2) of MHAA4549A19.0 ± 4.9117.8 ± 3.88
SecondaryObserved Clearance (CL-obs) of MHAA4549A
Time frame:
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Reported as:
Mean · mL/day
Observed Clearance (CL-obs) of MHAA4549A
mL/dayMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Observed Clearance (CL-obs) of MHAA4549A288 ± 158350 ± 130
SecondaryObserved Steady State Volume of Distribution (Vss_obs) of MHAA4549A
Time frame:
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Reported as:
Mean · mL
Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A
mLMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A6410 ± 31707450 ± 2270

Adverse events

Collected over From randomization up to 60 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + Oseltamivir4/56 (7.1%)8/56 (14.3%)28/56 (50%)
MHAA4549A 3600 mg + Oseltamivir6/55 (10.9%)11/55 (20%)26/55 (47.3%)
MHAA4549A 8400 mg + Oseltamivir4/47 (8.5%)12/47 (25.5%)18/47 (38.3%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
PneumoniaInfections and infestations1/563/553/47
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/561/552/47
Septic shockInfections and infestations2/561/550/47
BronchitisInfections and infestations0/560/551/47
TonsillitisInfections and infestations0/560/551/47
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders0/561/551/47
DyspnoeaRespiratory, thoracic and mediastinal disorders0/560/551/47
PneumomediastinumRespiratory, thoracic and mediastinal disorders0/560/551/47
Respiratory failureRespiratory, thoracic and mediastinal disorders0/560/551/47
Abdominal wall haematomaGastrointestinal disorders0/560/551/47
Most frequent other events
Showing 10 of 17
Most frequent other events
EventPlacebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + Oseltamivir
DiarrhoeaGastrointestinal disorders7/563/550/47
HypertensionVascular disorders7/561/554/47
HaematuriaRenal and urinary disorders3/565/550/47
HypokalaemiaMetabolism and nutrition disorders4/562/554/47
NauseaGastrointestinal disorders4/564/551/47
ConstipationGastrointestinal disorders2/564/552/47
Atrial fibrillationCardiac disorders3/564/552/47
PyrexiaGeneral disorders2/564/552/47
HypophosphataemiaMetabolism and nutrition disorders4/562/552/47
AgitationPsychiatric disorders4/563/551/47

Baseline characteristics

Safety Population included all randomized participants who received study drug, with participants grouped according to the treatment actually received.

Age, Continuous
Age, Continuous(years)Placebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + OseltamivirTotal
Mean65.7 ± 17.556.5 ± 18.259.8 ± 17.960.7 ± 18.2
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + OseltamivirTotal
Female24252271
Male32302587
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + OseltamivirTotal
Hispanic or Latino1320841
Not Hispanic or Latino37283499
Not Stated67518
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo + OseltamivirMHAA4549A 3600 mg + OseltamivirMHAA4549A 8400 mg + OseltamivirTotal
American Indian or Alaska native1012
Asian4026
Black or African American1102
White454439128
Multiple0101
Unknown59519
08

Study locations

171 sites
  • CHU St Pierre (St Pierre)
    Brussels, 1000, Belgium
  • Hospital Erasme; Neurologie
    Bruxelles, 1070, Belgium
  • UZ Leuven Gasthuisberg
    Leuven, 3000, Belgium
  • CHU UCL Mont-Godinne
    Mont-godinne, 5530, Belgium
  • Santa Casa de Misericordia; de Belo Horizonte
    Belo Horizonte, MG 30150-221, Brazil
  • Hospital Sao Vicente de Paulo
    Passo Fundo, RS 99010-080, Brazil
  • PUC Campinas
    Campinas, SP 13060-904, Brazil
  • FUNFARME
    Sao Jose do Rio Preto, SP 15090-000, Brazil
  • Hospital Alemao Oswaldo Cruz; Oncologia
    Sao Paulo, SP 01323-020, Brazil
  • Hospital Edmundo Vasconcelos
    Vila Clementino, SP 04038-905, Brazil
  • MHAT "Dr. Tota Venkova"- Gabrovo
    Gabrovo, 5300, Bulgaria
  • University Multiprofile Hospital for Active Treatment "St. George"
    Plovdiv, 4005, Bulgaria
  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
    Ruse, 7002, Bulgaria
  • Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD
    Sevlievo, 5400, Bulgaria
  • MHAT Lyulin EAD, Department of internal diseases
    Sofia, 1336, Bulgaria
  • MHAT TOKUDA SOFIA/ICU-Intensive Care Unit
    Sofia, 1407, Bulgaria
  • 5th Multifunctional Hospital for Active treatment
    Sofia, 1606, Bulgaria
  • Military Medical Academy- MHAT
    Sofia, 1606, Bulgaria
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
    Sofia, 1606, Bulgaria
  • MBAL St Marina Dep Pulmonology, ICU
    Varna, 9010, Bulgaria
  • Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD
    Veliko Tarnovo, 5000, Bulgaria
  • Peter Lougheed Centre
    Calgary, Alberta T1Y 6J4, Canada
  • Alberta Health Services
    Calgary, Alberta T2N 4N2, Canada
  • Foothills Medical Centre
    Calgary, Alberta T2N 4Z6, Canada
  • Rockyview General Hospital
    Calgary, Alberta T2V 1P9, Canada
  • Royal Columbian Hospital
    New Westminster, British Columbia V3L 3W7, Canada
  • St. Paul's Hospital, Providence Health Care
    Vancouver, British Columbia V6Z 1Y6, Canada
  • Victoria General Hospital
    Victora, British Columbia V8Z 6R5, Canada
  • Royal Jubilee Hospital Victoria general Hospital
    Victoria, British Columbia V8R 1J8, Canada
  • Moncton Hospital
    Moncton, New Brunswick E1C 6Z8, Canada
  • LHSC - University Hospital; Research Pharmacy
    London, Ontario N6A 5A5, Canada
  • Lakeridge Health
    Oshawa, Ontario L1G 2B9, Canada
  • Ottawa Hospital Research Institute
    Ottawa, Ontario K1Y 4E9, Canada
  • The Ottawa Hospital - Civic Campus
    Ottawa, Ontario K1Y 4E9, Canada
  • Toronto East General
    Toronto, Ontario M4C 3E7, Canada
  • University Health Network
    Toronto, Ontario M5G 2N2, Canada
  • Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
  • Centre Hospitalier de la Universite Laval
    Quebec City, Quebec G1V 4G5, Canada
  • Pavillion Chul-Chuq
    Sainte-foy, Quebec G1V 4G2, Canada
  • Centre de santé et de services sociaux de Trois-Rivières
    Trois-Rivieres, Quebec G9A1Y1, Canada
  • Hospital Dr. Hernan Henriquez Aravena
    Temuco, 4781151, Chile
  • Clinica Renaca
    Vina del Mar, 2540364, Chile
  • The University Hospital Brno
    Brno, 62500, Czechia
  • Fakultni nemocnice Hradec Kralove
    Hradec Kralove, 500 05, Czechia
  • Anesthesia and Intensive Care Dept., Regional Hospital Liberec
    Liberec, 460 63, Czechia
  • University hospital Ostrava, Clinic of infectious medicine
    Ostrava, 708 52, Czechia
  • Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace
    Praha 10, 100 34, Czechia
  • CH Victor Dupouy
    Argenteuil, 95107, France
  • Centre Hospitalier Universitaire de Clermont Ferrand
    Clermont-ferrand, 63000, France
  • Service de Réanimation médicale - Bocage Central
    Dijon, 21079, France
  • APHP Raymond Poincare
    Garches, 92380, France
  • CHD Vendée
    La Roche Sur Yon, 85025, France
  • CHRU Lille
    Lille, 59037, France
  • Réanimation Polyvalente, CHU Limoges
    Limoges, 87043, France
  • CHRU Nancy
    Nancy, 54035, France
  • Archet 1 university Hospital
    Nice, 6202, France
  • HOPITAL COCHIN university hospital
    Paris, 75014, France
  • Réanimation médicale NHC
    Strasbourg, 67000, France
  • Hopital Universitaire Hautepierre
    Strasbourg, 67098, France
  • Service de réanimation médicale, Hôpital Bretonneau
    Tours, 37044, France
  • Universitätsklinikum Frankfurt Goethe Universität
    Frankfurt, 60590, Germany
  • Universitätsklinikum Heidelberg
    Heidelberg, 69120, Germany
  • Uniklinik Köln, Medizinischen Klinik I
    Koeln, 50931, Germany
  • Uniklinikum Mainz
    Mainz, 55131, Germany
  • Uniklinik Tübingen
    Tuebingen, 72076, Germany
  • University of Hong Kong
    Hong Kong, Hong Kong
  • Pest Megyei Flor Ferenc Korhaz
    Kistarcsa, 2084, Hungary
  • Csolnoky Ferenc Kórház
    Veszprém, 8200, Hungary
  • Jávorszky Ödön Hospital
    Vác, 2600, Hungary
  • Zala County Hospital ICU
    Zalaegerszeg, 8900, Hungary
  • Haemek Medical Center
    Afula, 18101, Israel
  • Soroka University Medical Centre
    Beer-Sheva, 84101, Israel
  • Wolfson Medical Center
    Holon, 58100, Israel
  • Hadasit Medical Research Services and Development Ltd
    Jerusalem, 91999, Israel
  • Galilee Medical Center
    Nahariya, 22100, Israel
  • Nazareth EMMS Hospital
    Nazareth, 16100, Israel
  • Rabin Medical Center
    Petah Tikva, 4941492, Israel
  • Kaplan Medical Center
    Rehovot, 7661041, Israel
  • Tel-Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
  • Chaim Sheba Medical Center
    Tel Hashomer, 52661, Israel
  • Ziv Medical Center
    Zefat, 1311001, Israel
  • University Division of Infective and Tropical Diseases, University of Brescia, Italy
    Brescia, Basilicata, Italy
  • Clinic of Infectious Diseases
    Bologna, Emilia-Romagna 40127, Italy
  • University Hospital Modena, Intensive Care Unit
    Modena, Emilia-Romagna 41125, Italy
  • National Institute for Infectious Diseases "L. Spallanzani"
    Rome, Lazio 149, Italy
  • Asst Di Cremona
    Cremona, Lombardia 26100, Italy
  • Ospedale San Raffaele - Milano
    Milano, Lombardia 20127, Italy
  • A.O.U. S. Giovanni di Dio e Ruggi d'Aragona
    Salerno, Sardegna 84131, Italy
  • Pusan National University Hospital
    Busan, 602-739, Korea, Republic of
  • Gachon University Gil Hospital
    Incheon, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
  • Yonsei University Health System/Severance Hospital
    Seoul, 120-752, Korea, Republic of
  • Hallym university Kangnam Sacred Heart Hospital; Infectious devision
    Seoul, 150-950, Korea, Republic of
  • Wonju Severance Christian Hospital
    Wonju, 220-701, Korea, Republic of
  • Hospital Civil de Guadalajara Dr Juan I Menchaca
    Guadalajara, 44280, Mexico
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
    Guadalajara, 44280, Mexico
  • Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran
    Mexico, Distrito Federal, 14000, Mexico
  • CEPREP; Hospital Universitario
    Monterrey, 64460, Mexico
  • Hospital General de Tijuana
    Tijuana, 22320, Mexico

Showing the first 100 of 171 sites across 25 countries.

09

References and documents

Publications

  • Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7):e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23. PubMed 32393496 ↗

Study documents

  • Protocol and statistical analysis plan · May 16, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02293863
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Nov 18, 2014
Start date
Jan 14, 2015
Primary completion
May 23, 2017
Completion
May 23, 2017
Results posted
Jun 18, 2018
Last update
Jun 18, 2018

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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