Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 17, 2020

Primary Completion Date

August 25, 2021

Study Completion Date

October 25, 2021

Conditions
COVID-19
Interventions
BIOLOGICAL

GAMUNEX-C

Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified.

DRUG

Standard Medical Treatment

SMT per local policies or guidelines.

Trial Locations (18)

10032

Columbia University Medical Center, New York

15212

Allegheny Health Network Research Institute, Pittsburgh

19140

Temple University Hospital, Philadelphia

27517

Wake Forest Baptist Medical Center, Winston-Salem

40202

University of Louisville, Louisville

44304

Summa Health, Akron

48043

McLaren Health Care-Macomb, Mount Clemens

48342

McLaren Health Care Oakland, Pontiac

48532

McLaren Flint, Flint

60612

University of Illinois at Chicago, Chicago

67214

Via Christi Research, Wichita

68124

CHI Health, Omaha

71103

Louisiana State University Health Sciences Center, Shreveport

75701

CHRISTUS Health, Tyler

85224

Chandler Regional Medical Center, Chandler

92118

Southern California Research Center, Coronado

98405

MultiCare Tacoma General Hospital, Tacoma

99204

MultiCare Deaconess Hospital, Spokane

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY

NCT04480424 - Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19) | Biotech Hunter | Biotech Hunter