- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028909
Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Type A Influenza.
A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Influenza Caused by Type A Strains
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study drugs or interpretation of subject safety or study results.
- Concurrent enrollment in another clinical study involving an investigational treatment. -Hospitalized > 72 hours (> 3 days) prior to receipt of a positive diagnostic test for influenza A.
- Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor. -Receipt of any investigational antiviral medications within 30 days prior to study drug dosing.
- Previous receipt of an influenza mAb within past 100 days.
- Pregnant or nursing female.
- History of allergic disease or reactions likely to be exacerbated by any components of the study drugs (MEDI8852 or oseltamivir).
- Diagnosis of influenza B infection within 14 days prior to randomization.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oseltamivir + low dose MEDI8852
Low Dose of MEDI8852 + Oseltamivir will be studied
|
Standard of care for influenza caused by Type A strains
Other Names:
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
|
Experimental: Oseltamivir + high dose MEDI8852
High dose of MEDI8852 + Oseltamivir will be studied.
|
Standard of care for influenza caused by Type A strains
Other Names:
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
|
Active Comparator: Oseltamivir + Placebo
Oseltamivir in conjunction with placebo will be studied.
|
Standard of care for influenza caused by Type A strains
Other Names:
Salt-water solution containing no active ingredients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of efficacy as defined as time to normalization of respiratory function.
Time Frame: Through Day 14
|
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
Time Frame: Through Day 28
|
Occurrence of adverse events.
|
Through Day 28
|
The occurence of Serious Adverse Events
Time Frame: Through Study Day 60
|
Occurrence of serious adverse events.
|
Through Study Day 60
|
The occurence of Adverse Events of Special Interest (AESIs)
Time Frame: Through Day 60
|
Occurrence of Adverse Events of Special Interest.
|
Through Day 60
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the effect of MEDI8852 in reducing severity of clinical status.
Time Frame: Through Day 7
|
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
|
Evaluation of time to hospital discharge.
Time Frame: Through Day 60
|
Evaluation of time to hospital discharge.
|
Through Day 60
|
Quantitation of influenza viral shedding by qRT-PCR.
Time Frame: Through Day 60
|
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.
Time Frame: Through Day 60
|
To evaluate serum concentration of MEDI8852 through Day 60.
|
Through Day 60
|
Evaluation of serum ADA responses in serum through Day 60.
Time Frame: Through Day 60
|
To evaluate the ADA response through Day 60.
|
Through Day 60
|
Evaluation of time to ICU discharge.
Time Frame: Through Day 60
|
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.
Time Frame: Through Day 14
|
To evaluate time to clinical resolution of vital sign abnormalities.
|
Through Day 14
|
Evaluation of Change in NEWS from baseline through Day 14.
Time Frame: 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.
Time Frame: Through Day 60
|
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.
Time Frame: Through Day 60
|
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
Time Frame: Through Day 60
|
To evaluate All-cause mortality.
|
Through Day 60
|
Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.
Time Frame: Through Day 60
|
To evaluate the rate of all-cause re-admission during the study.
|
Through Day 60
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Wounds and Injuries
- Orthomyxoviridae Infections
- Influenza, Human
- Sprains and Strains
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Oseltamivir
- MEDI8852
Other Study ID Numbers
- D6000C00003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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