Patients hospitalized with influenza caused by Type A strains MedDRA version: 19.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: MEDI8852
Product Code: MEDI8852
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not assigned
Current Sponsor code: MEDI8852
Other descriptive name: HUMAN
Sponsors
MedImmune, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older at the time of screening. 2. Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations. 3. Females of childbearing potential who are sexually active with a nonsterilized male partner must have evidence of not being pregnant upon enrollment and have a negative pregnancy test prior to administration of investigational product. 4. Hospitalized = 72 hours prior to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid antigen test, or confirmed with culture, polymerase chain reaction, or antigen testing at the study site. 5. Onset of influenza symptoms = 144 hours (= 6 days) prior to randomization. 6. Receiving supplemental oxygen. 7. Expected to participate in the study through Day 60. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: 1. Any condition that, in the opinion of the investigator, would interfere with evaluation of study drugs or interpretation of subject safety or study results. 2. Concurrent enrollment in another clinical study involving an investigational treatment. 3. Hospitalized > 72 hours (> 3 days) prior to receipt of a positive diagnostic test for influenza A. 4. Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor. 5. Receipt of any investigational antiviral medications within 30 days prior to study drug dosing. 6. Previous receipt of an influenza mAb within past 100 days. 7. Pregnant or nursing female. 8. History of allergic disease or reactions likely to be exacerbated by any components of the study drugs (MEDI8852 or oseltamivir). 9. Diagnosis of influenza B infection within 14 days prior to randomization. 10. Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the effect of MEDI8852 administered in conjunction with oseltamivir and the effect of oseltamivir alone in reducing time to normalization of respiratory function 2. To compare the safety and tolerability of a single intravenous(IV) dose of MEDI8852 administered in conjunction with oseltamivir to the safety and tolerability of oseltamivir alone;Secondary Objective: To evaluate/determine: 1. the effect of MEDI8852 in reducing severity of clinical status 2. the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities 3.the effect of MEDI8852 in reducing NEWS 4.the effect of MEDI8852 in reducing time to hospital discharge 5.the effect of MEDI8852 in reducing time to ICU discharge 6.the effect of MEDI8852 in reducing the duration of mechanical ventilation 7.the effect of MEDI8852 in reducing the rates of ICU admission from the general ward 8.the effect of MEDI8852 on all-cause mortality 9.the effect of MEDI8852 on all-cause hospital re-admission rates during the study 10.the effect of MEDI8852 in reducing the duration and quantity of viral shedding by by quantitative reverse transcriptase (qRT-PCR) over time 11. To evaluate the serum concentration and PK of MEDI8852 12. To evaluate the serum ADA of MEDI8852;Primary end point(s): a. Time to normalization of respiratory function, defined as: i. For subjects without underlying chronic lung disease and not on supplemental oxygen prior to hospitalization, an oxygen saturation of = 95% for 24 hours on room air ii. For subjects with underlying chronic lung disease or on supplemental oxygen prior to hospitalization, a return to their baseline oxygen saturation and/or supplemental oxygen requirements as recorded during the 2 months prior to admission and not associated with a concurrent respiratory illness or the onset of influenza symptoms for 24 hours 2. Safety of MEDI8852 Treatment-emergent serious adverse events (TESAEs) treatment-emergent adverse | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Day 7 2-11. Followed through Day 60.;Secondary end point(s): 1. Ordinal outcome of clinical status 2. Time to clinical resolution of individual vital signs abnormalities, including temperature, respiration rate, heart rate, and blood pressure 3. Change in NEWS from baseline to Day 3 4. Time to hospital discharge 5. Time to ICU discharge 6. Duration of mechanical ventilation 7. Rate of ICU admission from the general ward 8. All-cause mortality 9. Rate of all-cause re-admission during the study 10. Quantification of influenza viral shedding over time by qRT-PCR 11. MEDI8852 serum concentration and PK parameters 12. MEDI8852 ADA response in serum | — |
Countries
Australia, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, United States
Contacts
Public ContactInformation Center
MedImmune, LLC
Outcome results
None listed