Post-COVID Postural Orthostatic Tachycardia Syndrome

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS

NCT06524739 | PHASE 3 | INTERVENTIONAL

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 \[post-COVID-POTS\]).

35 Sites

177 Participants

RECRUITING

18 Years

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SUBMIT

University of Alabama Hospital at Birmingham

Birmingham,Alabama,United States,35294

Center for Complex Neurology, EDS & POTS

Phoenix,Arizona,United States,85006

Mayo Clinic Arizona

Scottsdale,Arizona,United States,85259

Arkansas Cardiology Clinic Little Rock

Little Rock,Arkansas,United States,72205

UC San Diego Health

La Jolla,California,United States,92037

University of california Irvine

Orange,California,United States,92868

National Jewish Health

Denver,Colorado,United States,80206

Velocity Clinical Research, Savannah

Savannah,Georgia,United States,31406

LSU Health Sciences Center

New Orleans,Louisiana,United States,70112

Velocity Clinical Research, Metairie

New Orleans,Louisiana,United States,70119

Johns Hopkins Bayview Medical Center PMR

Baltimore,Maryland,United States,21224

Mass General Brigham (Massachusetts General Hospital)

Belmont,Massachusetts,United States,02478

Profound Research LLC at Millennium Affiliated Physicians

Farmington Hills,Michigan,United States,48334

Velocity Clinical Research Lincoln

Lincoln,Nebraska,United States,68510

Dysautonomia Clinic

Buffalo,New York,United States,14221

NYU Langone Health South Shore Neurologic Associates

Patchogue,New York,United States,11772

Duke University Medical Center

Durham,North Carolina,United States,27710

Bernstein Clinical Research Center

Cincinnati,Ohio,United States,45236

University Hospital Cleveland Medical Center

Cleveland,Ohio,United States,44195

Penn Presbyterian Medical Center

Philadelphia,Pennsylvania,United States,19104

Velocity Clinical Research Union

Union,South Carolina,United States,29379

Vanderbilt University Medical Center

Nashville,Tennessee,United States,37232

UT Austin Dell Medical School

Austin,Texas,United States,78712

University of Texas Southwestern Medical Center

Dallas,Texas,United States,75390

Prolato Clinical Research Center

Houston,Texas,United States,77054

Sunbeam Clinical Research

McKinney,Texas,United States,75069

University of Texas Health Science Center

San Antonio,Texas,United States,78229

Bateman Horne Center

Salt Lake City,Utah,United States,84102

Metrodora Institute

West Valley City,Utah,United States,84119

Velocity Clinical Research Hampton

Hampton,Virginia,United States,23666

VCU Health

Richmond,Virginia,United States,23219

Libin Cardiovascular Institute University of Calgary

Calgary,Virginia,Canada,T2N4Z6

University of Alberta Hospital

Edmonton,Virginia,Canada,T6G2B7

McGill University Health Centre

Québec,Virginia,Canada,H4A3J1

CiussseChus

Sherbrooke,Virginia,Canada,J1H5N4

Study Eligibility Criteria

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

Additional Studies

Additional studies can be found at ClinicalTrials.gov