This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlledstudy to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses ofIgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatictachycardia syndrome (post-Coronavirus Disease 2019 [COVID-19] POTS [post-COVID-POTS]).
Not Provided
Biological: IgPro20
IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G
(IgG) for subcutaneous (SC) administration
Other Name: HIZENTRA®
Biological: Placebo
2% human albumin solution administered subcutaneously as a volume-matched dose to the
experimental IMP.
Inclusion Criteria:
1. Provide written informed consent and be willing and, in the opinion of the
investigator, able to adhere to all protocol requirements.
2. Males and females aged ≥ 18 at the time of providing written informed consent.
3. Diagnosis of post-COVID POTS, defined by both a preceding COVID-19 infection based
on confirmed historical documentation and onset of POTS symptoms developing within 4
months after COVID-19 infection as defined per consensus criteria.
4. COMPASS-31 score of at least 40 at the Screening visit.
5. Positive confirmatory standardized standing test (ie, HR increase of ≥ 30 bpm [≥ 40
bpm for participants aged 18 to 19 years] within 10 minutes in the absence of
orthostatic hypotension) at the Screening visit.
Exclusion Criteria:
1. Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before
Screening
2. Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19
infection
3. Prior diagnosis of or receiving current treatment at Screening for the following
conditions (unless onset was related to the inciting POTS-associated COVID-19
infection): certain neurologic, autoimmune, endocrine, cardiac, or other disorders,
and pre-existing psychiatric disorders
4. Presence of active infections, including human immunodeficiency virus infection,
hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic
infection
University of Alabama Hospital at Birmingham
Birmingham 4049979, Alabama 4829764, United States
Center for Complex Neurology, EDS & POTS
Phoenix 5308655, Arizona 5551752, United States
Mayo Clinic Arizona
Scottsdale 5313457, Arizona 5551752, United States
Arkansas Cardiology Clinic - Little Rock
Little Rock 4119403, Arkansas 4099753, United States
UC San Diego Health
La Jolla 5363943, California 5332921, United States
University of california Irvine
Orange 5379513, California 5332921, United States
National Jewish Health
Denver 5419384, Colorado 5417618, United States
Hope Research Network
Miami 4164138, Florida 4155751, United States
Well Pharma Medical Research, Corp
Miami 4164138, Florida 4155751, United States
Velocity Clinical Research, Savannah
Savannah 4221552, Georgia 4197000, United States
LSU Health Sciences Center
New Orleans 4335045, Louisiana 4331987, United States
Velocity Clinical Research, Metairie
New Orleans 4335045, Louisiana 4331987, United States
Johns Hopkins Bayview Medical Center PMR
Baltimore 4347778, Maryland 4361885, United States
Mass General Brigham (Massachusetts General Hospital)
Belmont 4930282, Massachusetts 6254926, United States
Profound Research LLC at Millennium Affiliated Physicians
Farmington Hills 4992523, Michigan 5001836, United States
Velocity Clinical Research - Lincoln
Lincoln 5072006, Nebraska 5073708, United States
Dysautonomia Clinic
Buffalo 5110629, New York 5128638, United States
NYU Langone Health South Shore Neurologic Associates
Patchogue 5130672, New York 5128638, United States
Duke University Medical Center
Durham 4464368, North Carolina 4482348, United States
Bernstein Clinical Research Center
Cincinnati 4508722, Ohio 5165418, United States
University Hospital Cleveland Medical Center
Cleveland 5150529, Ohio 5165418, United States
Hightower Clinical
Oklahoma City 4544349, Oklahoma 4544379, United States
Penn Presbyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927, United States
Velocity Clinical Research - Union
Union 4599214, South Carolina 4597040, United States
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168, United States
UT Austin Dell Medical School
Austin 4671654, Texas 4736286, United States
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286, United States
Prolato Clinical Research Center
Houston 4699066, Texas 4736286, United States
Sunbeam Clinical Research
McKinney 4710178, Texas 4736286, United States
University of Texas Health Science Center
San Antonio 4726206, Texas 4736286, United States
Bateman Horne Center
Salt Lake City 5780993, Utah 5549030, United States
Metrodora Institute
West Valley City 5784607, Utah 5549030, United States
Velocity Clinical Research - Hampton
Hampton 4762894, Virginia 6254928, United States
VCU Health
Richmond 4781708, Virginia 6254928, United States
Libin Cardiovascular Institute University of Calgary
Calgary 5913490, Canada
University of Alberta Hospital
Edmonton 5946768, Canada
McGill University Health Centre
Québec 6325494, Canada
Ciussse-Chus
Sherbrooke 6146143, Canada
Study Director, Study Director
CSL Behring