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

Last updated: April 14, 2025
Sponsor: CSL Behring
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Defect

Fast Heart Rate (Tachycardia)

Heart Disease

Treatment

Placebo

IgPro20

Clinical Study ID

NCT06524739
IgPro20_3010
2023-508744-22-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Provide written informed consent and be willing and, in the opinion of theinvestigator, 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 basedon confirmed historical documentation and onset of POTS symptoms developing within 4months 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 [≥ 40bpm for participants aged 18 to 19 years] within 10 minutes in the absence oforthostatic hypotension) at the Screening visit.

Exclusion

Exclusion Criteria:

  1. Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks beforeScreening

  2. Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19infection

  3. Prior diagnosis of or receiving current treatment at Screening for the followingconditions (unless onset was related to the inciting POTS-associated COVID-19infection): 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 systemicinfection

Study Design

Total Participants: 177
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 28, 2024
Estimated Completion Date:
September 24, 2027

Connect with a study center

  • Libin Cardiovascular Institute University of Calgary

    Calgary, T2N 4Z6
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, T6G 2B7
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Québec, H4A 3J1
    Canada

    Active - Recruiting

  • Ciussse-Chus

    Sherbrooke, J1H 5N4
    Canada

    Site Not Available

  • University of Alabama Hospital at Birmingham

    Birmingham, Alabama 35294-1152
    United States

    Site Not Available

  • Center for Complex Neurology, EDS & POTS

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Arkansas Cardiology

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Arkansas Cardiology Clinic - Little Rock

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • UC San Diego Health

    La Jolla, California 92037
    United States

    Site Not Available

  • Velocity Clinical Research - Slidell

    Los Angeles, California 70458
    United States

    Site Not Available

  • University of california Irvine

    Orange, California 92868
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • Hope Research Network

    Miami, Florida 33166
    United States

    Site Not Available

  • Well Pharma Medical Research, Corp

    Miami, Florida 33173
    United States

    Site Not Available

  • Velocity Clinical Research, Savannah

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • LSU Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Velocity Clinical Research, Metairie

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Johns Hopkins Bayview Medical Center PMR

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Velocity Clinical Research - Rockville

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Mass General Brigham (Massachusetts General Hospital)

    Belmont, Massachusetts 02478
    United States

    Site Not Available

  • St. Elizabeth's Medical Center

    Boston, Massachusetts 02135
    United States

    Site Not Available

  • Profound Research LLC at Millennium Affiliated Physicians

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Velocity Clinical Research - Lincoln

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Dysautonomia Clinic

    Buffalo, New York 14221
    United States

    Active - Recruiting

  • NYU Langone Health South Shore Neurologic Associates

    Patchogue, New York 11772
    United States

    Site Not Available

  • South Shore Neurologic Associates

    Patchogue, New York 11772
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Bernstein Clinical Research Center

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Hightower Clinical

    Oklahoma City, Oklahoma 73134
    United States

    Site Not Available

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Velocity Clinical Research - Union

    Union, South Carolina 29379
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • UT Austin Dell Medical School

    Austin, Texas 78712
    United States

    Active - Recruiting

  • The Heartbeat Clinic

    Dallas, Texas 75230
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Sunbeam Clinical Research

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Bateman Horne Center

    Salt Lake City, Utah 84102
    United States

    Active - Recruiting

  • Metrodora Institute

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • Velocity Clinical Research - Hampton

    Hampton, Virginia 23666
    United States

    Site Not Available

  • VCU Health

    Richmond, Virginia 23219
    United States

    Site Not Available

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