Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

NCT ID: NCT03315104

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2019-06-17

Brief Summary

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

Conditions

Influenza A H3N2; Influenza A H1N1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FLU-IGIV High Dose

Participants will receive a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive standard of care (SOC) antiviral treatment for flu. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.

FLU-IGIV: Single dose, sterile liquid formulation for IV administration.

Group Type: EXPERIMENTAL

FLU-IGIV

Intervention Type: BIOLOGICAL

Single dose, sterile liquid formulation for IV administration.

FLU-IGIV Low Dose

Participants will receive a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.

FLU-IGIV: Single dose, sterile liquid formulation for IV administration.

Group Type: EXPERIMENTAL

FLU-IGIV

Intervention Type: BIOLOGICAL

Single dose, sterile liquid formulation for IV administration.

FLU-IGIV Placebo

Participants will receive a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered IV as 500 mL of normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.

Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration.

Group Type: PLACEBO_COMPARATOR

Placebo for FLU-IGIV

Intervention Type: OTHER

Single dose, normal saline solution for IV administration.

Interventions

FLU-IGIV

Single dose, sterile liquid formulation for IV administration.

Intervention Type: BIOLOGICAL

Placebo for FLU-IGIV

Single dose, normal saline solution for IV administration.

Intervention Type: OTHER

Other Intervention Names

Anti-influenza immunoglobulin intravenous (Human); NP-025

Eligibility Criteria

Inclusion Criteria

• Provision of voluntary informed consent in writing by patient, or legally authorized representative.
• Age ≥ 18 years of age.
• Locally determined positive influenza A infection (Rapid Antigen (Ag) Test or PCR) from a specimen obtained within 2 days prior to randomization.
• Onset of symptoms ≤ 6 days before randomization, defined as when the patient first experienced at least one respiratory symptom or fever.
• Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for more than 24 hours and will be/already are receiving antiviral SOC.
• Experiencing ≥ 1 respiratory symptom (ex. cough, sore throat, nasal congestion) and ≥ 1 constitutional symptom (ex. headache, myalgia, feverishness or fatigue).
• For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least 1 form of hormonal or barrier contraception through Day 60 of the study.
• Willingness to have blood and respiratory samples obtained and stored.
• National Early Warning Score (NEW score) ≥ 3 at screening.

Exclusion Criteria

• Use of any investigational product within the past 30 days prior to screening.
• History of hypersensitivity to blood or plasma products (as judged by the site investigator).
• History of allergy to latex or rubber.
• Known medical history of IgA deficiency.
• Pregnancy or lactation.
• Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the patient (e.g. decompensated congestive heart failure), based on investigator's medical opinion with careful consideration of lab results.
• Liver function: liver function test (LFT) > 2.5 times upper limit of normal (ULN).
• Renal Function: glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 (age and sex adjusted).
• A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g. cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).
• An opinion of the investigator that it would be unwise to allow participation of the patient in the study (the reason for exclusion of the patient must be documented).
• Receiving extracorporeal membrane oxygenation (ECMO).
• Anticipated life expectancy of < 90 days.
• Confirmed bacterial pneumonia or any concurrent respiratory viral infection that is not influenza A (ex. respiratory syncytial virus (RSV) infection).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Hall

Role: STUDY_DIRECTOR

Emergent BioSolutions Inc

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

HonorHealth

Scottsdale, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

University of California, Irvine Emergency Medicine

Orange, California, United States

Denver public Health

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Christiana Care Health Systems

Newark, Delaware, United States

Northside Hospital

Atlanta, Georgia, United States

Atlanta Institute for Medical Research Inc.

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas medical Center

Kansas City, Kansas, United States

John Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Wayne State University/Detroit Receiving Hospital

Detroit, Michigan, United States

Wayne State University/Sinai Grace Hospital

Detroit, Michigan, United States

Providence-Providence Park Hospital, Southfield

Southfield, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Pulmonlx LLC Pulmonary & Critical Care Medicine

Greensboro, North Carolina, United States

Premier Health Miami Valley Hospital

Dayton, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

St Luke's University Health Network

Bethlehem, Pennsylvania, United States

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Regional Health

Rapid City, South Dakota, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

University of Utah HealthCare

Salt Lake City, Utah, United States

Carilion Medical Center

Roanoke, Virginia, United States

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States

Foothills Medical Centre

Calgary, Alberta, Canada

Health Sciences Center

Winnipeg, Manitoba, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Grace Hospital

Winnipeg, Manitoba, Canada

CISSS BSL/Hopital Regional de Rimouski

Rimouski, Quebec, Canada

Ciusss McQ

Trois-Rivières, Quebec, Canada

Mayaguez Medical Center

Mayagüez, , Puerto Rico

San Cristobal Hospital

Ponce, , Puerto Rico

Hospital Clinic of Barcelona

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitari Mutua Terrassa

Barcelona, , Spain

Reina Sofia University Hospital

Córdoba, , Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, , Spain

Countries

United States; Canada; Puerto Rico; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IA-001

Identifier Type: -

Identifier Source: org_study_id