Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS

PHASE3TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 28, 2024

Primary Completion Date

June 20, 2025

Study Completion Date

July 11, 2025

Conditions
Post-COVID Postural Orthostatic Tachycardia Syndrome
Interventions
BIOLOGICAL

IgPro20

IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration

BIOLOGICAL

Placebo

2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.

Trial Locations (38)

11772

NYU Langone Health South Shore Neurologic Associates, Patchogue

14221

Dysautonomia Clinic, Buffalo

19104

Penn Presbyterian Medical Center, Philadelphia

21224

Johns Hopkins Bayview Medical Center PMR, Baltimore

23219

VCU Health, Richmond

23666

Velocity Clinical Research - Hampton, Hampton

27710

Duke University Medical Center, Durham

29379

Velocity Clinical Research - Union, Union

31406

Velocity Clinical Research, Savannah, Savannah

33166

Hope Research Network, Miami

33173

Well Pharma Medical Research, Corp, Miami

37232

Vanderbilt University Medical Center, Nashville

44195

University Hospital Cleveland Medical Center, Cleveland

45236

Bernstein Clinical Research Center, Cincinnati

48334

Profound Research LLC at Millennium Affiliated Physicians, Farmington Hills

68510

Velocity Clinical Research - Lincoln, Lincoln

70112

LSU Health Sciences Center, New Orleans

70119

Velocity Clinical Research, Metairie, New Orleans

72205

Arkansas Cardiology Clinic - Little Rock, Little Rock

73134

Hightower Clinical, Oklahoma City

75069

Sunbeam Clinical Research, McKinney

75390

University of Texas Southwestern Medical Center, Dallas

77054

Prolato Clinical Research Center, Houston

78229

University of Texas Health Science Center, San Antonio

78712

UT Austin Dell Medical School, Austin

80206

National Jewish Health, Denver

84102

Bateman Horne Center, Salt Lake City

84119

Metrodora Institute, West Valley City

85006

Center for Complex Neurology, EDS & POTS, Phoenix

85259

Mayo Clinic Arizona, Scottsdale

92037

UC San Diego Health, La Jolla

92868

University of california Irvine, Orange

35294-1152

University of Alabama Hospital at Birmingham, Birmingham

02478

Mass General Brigham (Massachusetts General Hospital), Belmont

T2N 4Z6

Libin Cardiovascular Institute University of Calgary, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

H4A 3J1

McGill University Health Centre, Québec

J1H 5N4

Ciussse-Chus, Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY

NCT06524739 - Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS | Biotech Hunter | Biotech Hunter