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Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
Sponsor: CSL Behring
Summary
This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 \[COVID-19\] POTS \[post-COVID-POTS\]).
Official title: Double-blind, Randomized, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of IgPro20 (Subcutaneous Immunoglobulin, HIZENTRA®) in Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2024-08-28
Completion Date
2025-07-11
Last Updated
2026-04-13
Healthy Volunteers
No
Interventions
IgPro20
IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration
Placebo
2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.
Locations (38)
University of Alabama Hospital at Birmingham
Birmingham, Alabama, United States
Center for Complex Neurology, EDS & POTS
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Arkansas Cardiology Clinic - Little Rock
Little Rock, Arkansas, United States
UC San Diego Health
La Jolla, California, United States
University of california Irvine
Orange, California, United States
National Jewish Health
Denver, Colorado, United States
Hope Research Network
Miami, Florida, United States
Well Pharma Medical Research, Corp
Miami, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
Velocity Clinical Research, Metairie
New Orleans, Louisiana, United States
Johns Hopkins Bayview Medical Center PMR
Baltimore, Maryland, United States
Mass General Brigham (Massachusetts General Hospital)
Belmont, Massachusetts, United States
Profound Research LLC at Millennium Affiliated Physicians
Farmington Hills, Michigan, United States
Velocity Clinical Research - Lincoln
Lincoln, Nebraska, United States
Dysautonomia Clinic
Buffalo, New York, United States
NYU Langone Health South Shore Neurologic Associates
Patchogue, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Velocity Clinical Research - Union
Union, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Austin Dell Medical School
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Sunbeam Clinical Research
McKinney, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Bateman Horne Center
Salt Lake City, Utah, United States
Metrodora Institute
West Valley City, Utah, United States
Velocity Clinical Research - Hampton
Hampton, Virginia, United States
VCU Health
Richmond, Virginia, United States
Libin Cardiovascular Institute University of Calgary
Calgary, Canada
University of Alberta Hospital
Edmonton, Canada
McGill University Health Centre
Québec, Canada
Ciussse-Chus
Sherbrooke, Canada