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, 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
Trial Registration Coordinator
+1 610-878-4697
clinicaltrials@cslbehring.com
Study Director, Study Director
CSL Behring