TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 \[post-COVID-POTS\]).

Official Title

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)

Quick Facts

Study Start:2024-08-28
Study Completion:2025-07-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06524739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements.
  2. 2. Males and females aged ≥ 18 at the time of providing written informed consent.
  3. 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. 4. COMPASS-31 score of at least 40 at the Screening visit.
  5. 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.
  1. 1. Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening
  2. 2. Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19 infection
  3. 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. 4. Presence of active infections, including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

University of Alabama Hospital at Birmingham
Birmingham, Alabama, 35294-1152
United States
Center for Complex Neurology, EDS & POTS
Phoenix, Arizona, 85006
United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
Arkansas Cardiology Clinic - Little Rock
Little Rock, Arkansas, 72205
United States
UC San Diego Health
La Jolla, California, 92037
United States
University of california Irvine
Orange, California, 92868
United States
National Jewish Health
Denver, Colorado, 80206
United States
Hope Research Network
Miami, Florida, 33166
United States
Well Pharma Medical Research, Corp
Miami, Florida, 33173
United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
United States
LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Velocity Clinical Research, Metairie
New Orleans, Louisiana, 70119
United States
Johns Hopkins Bayview Medical Center PMR
Baltimore, Maryland, 21224
United States
Mass General Brigham (Massachusetts General Hospital)
Belmont, Massachusetts, 02478
United States
Profound Research LLC at Millennium Affiliated Physicians
Farmington Hills, Michigan, 48334
United States
Velocity Clinical Research - Lincoln
Lincoln, Nebraska, 68510
United States
Dysautonomia Clinic
Buffalo, New York, 14221
United States
NYU Langone Health South Shore Neurologic Associates
Patchogue, New York, 11772
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45236
United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44195
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Velocity Clinical Research - Union
Union, South Carolina, 29379
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
UT Austin Dell Medical School
Austin, Texas, 78712
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States
Sunbeam Clinical Research
McKinney, Texas, 75069
United States
University of Texas Health Science Center
San Antonio, Texas, 78229
United States
Bateman Horne Center
Salt Lake City, Utah, 84102
United States
Metrodora Institute
West Valley City, Utah, 84119
United States
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666
United States
VCU Health
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28
Study Completion Date2025-07-11

Study Record Updates

Study Start Date2024-08-28
Study Completion Date2025-07-11

Terms related to this study

Keywords Provided by Researchers

  • POTS

Additional Relevant MeSH Terms

  • Post-COVID Postural Orthostatic Tachycardia Syndrome