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)
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 \[post-COVID-POTS\]).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements.
• Males and females aged ≥ 18 at the time of providing written informed consent.
• 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.
• COMPASS-31 score of at least 40 at the Screening visit.
• 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.
Locations
United States
Alabama
University of Alabama Hospital at Birmingham
NOT_YET_RECRUITING
Birmingham
Arkansas
Arkansas Cardiology Clinic - Little Rock
RECRUITING
Little Rock
Arizona
Center for Complex Neurology, EDS & POTS
RECRUITING
Phoenix
Mayo Clinic Arizona
NOT_YET_RECRUITING
Scottsdale
California
UC San Diego Health
NOT_YET_RECRUITING
La Jolla
University of california Irvine
NOT_YET_RECRUITING
Orange
Colorado
National Jewish Health
ACTIVE_NOT_RECRUITING
Denver
Georgia
Velocity Clinical Research, Savannah
RECRUITING
Savannah
Louisiana
LSU Health Sciences Center
ACTIVE_NOT_RECRUITING
New Orleans
Velocity Clinical Research, Metairie
NOT_YET_RECRUITING
New Orleans
Massachusetts
Mass General Brigham (Massachusetts General Hospital)
NOT_YET_RECRUITING
Belmont
Maryland
Johns Hopkins Bayview Medical Center PMR
NOT_YET_RECRUITING
Baltimore
Michigan
Profound Research LLC at Millennium Affiliated Physicians
NOT_YET_RECRUITING
Farmington Hills
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
Nebraska
Velocity Clinical Research - Lincoln
RECRUITING
Lincoln
New York
Dysautonomia Clinic
RECRUITING
Buffalo
NYU Langone Health South Shore Neurologic Associates
NOT_YET_RECRUITING
Patchogue
Ohio
Bernstein Clinical Research Center
NOT_YET_RECRUITING
Cincinnati
University Hospital Cleveland Medical Center
ACTIVE_NOT_RECRUITING
Cleveland
Pennsylvania
Penn Presbyterian Medical Center
NOT_YET_RECRUITING
Philadelphia
South Carolina
Velocity Clinical Research - Union
NOT_YET_RECRUITING
Union
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
UT Austin Dell Medical School
RECRUITING
Austin
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
Prolato Clinical Research Center
NOT_YET_RECRUITING
Houston
Sunbeam Clinical Research
NOT_YET_RECRUITING
Mckinney
University of Texas Health Science Center
NOT_YET_RECRUITING
San Antonio
Utah
Bateman Horne Center
ACTIVE_NOT_RECRUITING
Salt Lake City
Metrodora Institute
RECRUITING
West Valley City
Virginia
Velocity Clinical Research - Hampton
NOT_YET_RECRUITING
Hampton
VCU Health
NOT_YET_RECRUITING
Richmond
Other Locations
Canada
Libin Cardiovascular Institute University of Calgary