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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Post-COVID Postural Orthostatic Tachycardia Syndrome

In brief

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 \[post-COVID-POTS\]).

Key facts

Study ID

NCT06524739

Run by

CSL Behring

People needed

16

Starts

2024-08-28

Expected to finish

2025-07-11

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening
• Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19 infection
• 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
• Presence of active infections, including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection

Where it is running

• University of Alabama Hospital at Birmingham — Birmingham, Alabama, United States
• Center for Complex Neurology, EDS & POTS — Phoenix, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Arkansas Cardiology Clinic - Little Rock — Little Rock, Arkansas, United States
• UC San Diego Health — La Jolla, California, United States
• University of california Irvine — Orange, California, United States
• National Jewish Health — Denver, Colorado, United States
• Hope Research Network — Miami, Florida, United States
• Well Pharma Medical Research, Corp — Miami, Florida, United States
• Velocity Clinical Research, Savannah — Savannah, Georgia, United States
• LSU Health Sciences Center — New Orleans, Louisiana, United States
• Velocity Clinical Research, Metairie — New Orleans, Louisiana, United States
• Johns Hopkins Bayview Medical Center PMR — Baltimore, Maryland, United States
• Mass General Brigham (Massachusetts General Hospital) — Belmont, Massachusetts, United States
• Profound Research LLC at Millennium Affiliated Physicians — Farmington Hills, Michigan, United States
• Velocity Clinical Research - Lincoln — Lincoln, Nebraska, United States
• Dysautonomia Clinic — Buffalo, New York, United States
• NYU Langone Health South Shore Neurologic Associates — Patchogue, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Bernstein Clinical Research Center — Cincinnati, Ohio, United States
• University Hospital Cleveland Medical Center — Cleveland, Ohio, United States
• Hightower Clinical — Oklahoma City, Oklahoma, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Velocity Clinical Research - Union — Union, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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