A Phase 2b Study to Evaluate the Efficacy and Safety of MEDI8852 inAdults who are Hospitalized with Influenza

Phase 1

Conditions: Patients hospitalized with influenza caused by Type A strains
MedDRA version: 19.0Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-004276-29-DE

Lead Sponsor: MedImmune, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 450

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

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.