Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
NCT ID: NCT06524739
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
16 participants
INTERVENTIONAL
2024-08-28
2025-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Period 2 (open-label): No masking
Study Groups
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IgPro20
IgPro20
IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration
Placebo
Placebo
2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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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
Countries
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Other Identifiers
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2023-508744-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
IgPro20_3010
Identifier Type: -
Identifier Source: org_study_id
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