Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza

PHASE3CompletedINTERVENTIONAL
Enrollment

329

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

June 7, 2018

Study Completion Date

June 7, 2018

Conditions
Influenza AInfluenza B
Interventions
BIOLOGICAL

Intravenous hyperimmune immunoglobulin (IVIG)

Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)

BIOLOGICAL

Placebo for IVIG

Administered IV as 500 mL of normal saline

Trial Locations (21)

10010

Cornell CRS, New York

10467

Montefiore Medical Center, The Bronx

15213

University of Pittsburgh, Pittsburgh

20892

National Institutes of Health Clinical Center, Bethesda

26506

West Virginia University, Morgantown

27710

Duke University, Durham

43210

OHIO State University (OSU) Wexner Medical Center, Columbus

44106

Case Western Reserve University, Cleveland

45409

Miami Valley Hospital, Dayton

48202

Henry Ford Hospital, Detroit

55417

Minneapolis VA Medical Center, Minneapolis

55905

Mayo Clinic, Rochester

60612

University of Illinois, Chicago

75235

UT Southwestern Medical Center, Dallas

80204

Denver Public Health, Denver

92103

UCSD Antiviral Research Center (A VRC), San Diego

08103

Cooper University Hospital, Camden

Unknown

Westmead Hospital, Sydney

Odense University Hospital, Odense

St James's University Hospital, Leeds

Churchill Hospital, Oxford

All Listed Sponsors
collaborator

University of Minnesota

OTHER

collaborator

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02287467 - Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza | Biotech Hunter | Biotech Hunter