The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.
The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult subjects who are hospitalized with influenza caused by Type A strains. Approximately 450 subjects will be enrolled at study centers in North America, Europe, and other regions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Standard of care for influenza caused by Type A strains
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
Salt-water solution containing no active ingredients.
Evaluation of efficacy as defined as time to normalization of respiratory function.
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.
Time frame: Through Day 14
The occurence of Adverse Events
Occurrence of adverse events.
Time frame: Through Day 28
The occurence of Serious Adverse Events
Occurrence of serious adverse events.
Time frame: Through Study Day 60
The occurence of Adverse Events of Special Interest (AESIs)
Occurrence of Adverse Events of Special Interest.
Time frame: Through Day 60
Assessment of the effect of MEDI8852 in reducing severity of clinical status.
Evaluation of the effect of MEDI8852 in reducing severity of clinical status defined by death, ICU, non-ICU hospitalization, but requiring supplemental oxygen, non-ICU hospitalization and not requiring supplemental oxygen, not hospitalized, but unable to resume normal activities, fully resumed normal activities
Time frame: Through Day 7
Evaluation of time to hospital discharge.
Evaluation of time to hospital discharge.
Time frame: Through Day 60
Quantitation of influenza viral shedding by qRT-PCR.
Evaluation of the effect of MEDI8852 in reducing the duration and quantity of viral shedding measured by qRT-PCR over time.
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Time frame: Through Day 60
Evaluation of serum concentrations and PK of MEDI8852.
To evaluate serum concentration of MEDI8852 through Day 60.
Time frame: Through Day 60
Evaluation of serum ADA responses in serum through Day 60.
To evaluate the ADA response through Day 60.
Time frame: Through Day 60
Evaluation of time to ICU discharge.
Evaluation of time to ICU discharge.
Time frame: Through Day 60
Evaluation of the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities.
To evaluate time to clinical resolution of vital sign abnormalities.
Time frame: Through Day 14
Evaluation of Change in NEWS from baseline through Day 14.
To evaluate the effect of MEDI8852 in reducing NEWS.
Time frame: Through Day 14
Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation.
To evaluate duration of mechanical ventilation.
Time frame: Through Day 60
Evaluation of the effect of MEDI8852 in reducing the rates of ICU admission from the general ward.
To evaluate the rate of ICU admission from the general ward.
Time frame: Through Day 60
Evaluation to determine the effect of MEDI8852 on all-cause mortality
To evaluate All-cause mortality.
Time frame: Through Day 60
Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.
To evaluate the rate of all-cause re-admission during the study.
Time frame: Through Day 60