Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

PHASE3CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

April 26, 2018

Study Completion Date

May 18, 2018

Conditions
Influenza A Virus Infection
Interventions
BIOLOGICAL

High-titer anti-influenza plasma

Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of at least 1:80

BIOLOGICAL

Low-titer anti-influenza plasma

Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of 1:10 or less

Trial Locations (30)

10016

New York University/Bellevue Hospital, New York

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

21201

University of Maryland Medical Center, Baltimore

21287

Johns Hopkins University, Baltimore

27710

Duke University, Durham

28207

Carolinas Medical Center, Charlotte

32608

University of Florida, Gainesville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45267

University of Cincinnati, Cincinnati

48073

Beaumont Hospital - Royal Oak, Royal Oak

48085

Beaumont Hospital, Troy, Troy

48109

University of Michigan, Ann Arbor

55905

Mayo Clinic Campus Saint Mary's, Rochester

60612

Rush University Medical Center, Chicago

63110

St. Louis Children's Hospital at Washington University, St Louis

68124

Creighton University Medical Center, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75235

UT Southwestern Medical Center, Dallas

80045

Children's Hospital Colorado, Aurora

University of Colorado Denver, Aurora

85724

University of Arizona Health Sciences Center, Tucson

92134

Naval Medical Center San Diego (NMCSD), San Diego

98431

Madigan Army Medical Center (MAMC), Tacoma

90095-1752

UCLA Pediatrics Infectious Diseases, Los Angeles

06610

Bridgeport Hospital, Bridgeport

021141

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

01655

University of Massachusetts Medical School, Worcester

05405

University of Vermont, Burlington

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02572817 - Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A | Biotech Hunter | Biotech Hunter