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Study is withdrawn due to company decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir + low dose MEDI8852 | Experimental | Low Dose of MEDI8852 + Oseltamivir will be studied |
|
| Oseltamivir + high dose MEDI8852 | Experimental | High dose of MEDI8852 + Oseltamivir will be studied. |
|
| Oseltamivir + Placebo | Active Comparator | Oseltamivir in conjunction with placebo will be studied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Standard of care for influenza caused by Type A strains |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through Day 14 |
| The occurence of Adverse Events | Occurrence of adverse events. | Through Day 28 |
| The occurence of Serious Adverse Events | Occurrence of serious adverse events. | Through Study Day 60 |
| The occurence of Adverse Events of Special Interest (AESIs) | Occurrence of Adverse Events of Special Interest. | Through Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through Day 7 |
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Inclusion Criteria:
Age 18 years or older at the time of screening. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States, Data Privacy Directive in Europe) obtained from the subject/legal representative prior to performing any protocol related procedures, including screening evaluations.
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. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), premenarchal, or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Hospitalized ≤ 72 hours prior to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid antigen test (supplied or approved by the sponsor), or confirmed with culture, polymerase chain reaction, or antigen testing at the study site. Onset of influenza symptoms ≤ 144 hours (≤ 6 days) prior to randomization. Receiving supplemental oxygen. Expected to participate in the study through Day 60.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| C000627863 | MEDI8852 |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| MEDI8852 | Drug | MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion. |
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| Placebo | Drug | Salt-water solution containing no active ingredients. |
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| Evaluation of time to hospital discharge. | Evaluation of time to hospital discharge. | 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. | Through Day 60 |
| Evaluation of serum concentrations and PK of MEDI8852. | To evaluate serum concentration of MEDI8852 through Day 60. | Through Day 60 |
| Evaluation of serum ADA responses in serum through Day 60. | To evaluate the ADA response through Day 60. | Through Day 60 |
| Evaluation of time to ICU discharge. | Evaluation of time to ICU discharge. | 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. | Through Day 14 |
| Evaluation of Change in NEWS from baseline through Day 14. | To evaluate the effect of MEDI8852 in reducing NEWS. | Through Day 14 |
| Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation. | To evaluate duration of mechanical ventilation. | 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. | Through Day 60 |
| Evaluation to determine the effect of MEDI8852 on all-cause mortality | To evaluate All-cause mortality. | 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. | Through Day 60 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |