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

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 \[post-COVID-POTS\]).

Conditions

Post-COVID Postural Orthostatic Tachycardia Syndrome

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Study Overview

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Study Details

Study overview

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 \[post-COVID-POTS\]).

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)

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

Condition
Post-COVID Postural Orthostatic Tachycardia Syndrome
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Hospital at Birmingham, Birmingham, Alabama, United States, 35294-1152

Phoenix

Center for Complex Neurology, EDS & POTS, Phoenix, Arizona, United States, 85006

Scottsdale

Mayo Clinic Arizona, Scottsdale, Arizona, United States, 85259

Little Rock

Arkansas Cardiology Clinic - Little Rock, Little Rock, Arkansas, United States, 72205

La Jolla

UC San Diego Health, La Jolla, California, United States, 92037

Orange

University of california Irvine, Orange, California, United States, 92868

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Savannah

Velocity Clinical Research, Savannah, Savannah, Georgia, United States, 31406

New Orleans

LSU Health Sciences Center, New Orleans, Louisiana, United States, 70112

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21224

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CSL Behring,

Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

2027-09-24