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

NCT06524739 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: IgPro20_30102023-508744-22-00
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 38

Brief 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 \[post-COVID-POTS\]).

Conditions

Post-COVID Postural Orthostatic Tachycardia Syndrome

Keywords

POTS

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension])

  The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of \>=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure \[SBP; orthostatic hypotension\]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS.

  At Baseline and at Week 25

Secondary Outcomes (9)

• Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)

  At Baseline and at Week 25

• Change From Baseline in COMPASS-31 Total Score

  At Baseline and at Week 25

• Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test

  At Baseline and at Week 25

• Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE

  Up to Week 45

• Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE

  Up to Week 45

Study Arms (2)

IgPro20

EXPERIMENTAL

Biological: IgPro20

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

IgPro20 BIOLOGICAL

IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration

Also known as: HIZENTRA®

IgPro20

Placebo BIOLOGICAL

2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (38)

University of Alabama Hospital at Birmingham

Birmingham, Alabama, 35294-1152, United States

Location

Center for Complex Neurology, EDS & POTS

Phoenix, Arizona, 85006, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Arkansas Cardiology Clinic - Little Rock

Little Rock, Arkansas, 72205, United States

Location

UC San Diego Health

La Jolla, California, 92037, United States

Location

University of california Irvine

Orange, California, 92868, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Hope Research Network

Miami, Florida, 33166, United States

Location

Well Pharma Medical Research, Corp

Miami, Florida, 33173, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Velocity Clinical Research, Metairie

New Orleans, Louisiana, 70119, United States

Location

Johns Hopkins Bayview Medical Center PMR

Baltimore, Maryland, 21224, United States

Location

Mass General Brigham (Massachusetts General Hospital)

Belmont, Massachusetts, 02478, United States

Location

Profound Research LLC at Millennium Affiliated Physicians

Farmington Hills, Michigan, 48334, United States

Location

Velocity Clinical Research - Lincoln

Lincoln, Nebraska, 68510, United States

Location

Dysautonomia Clinic

Buffalo, New York, 14221, United States

Location

NYU Langone Health South Shore Neurologic Associates

Patchogue, New York, 11772, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45236, United States

Location

University Hospital Cleveland Medical Center

Cleveland, Ohio, 44195, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73134, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Velocity Clinical Research - Union

Union, South Carolina, 29379, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Austin Dell Medical School

Austin, Texas, 78712, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

Sunbeam Clinical Research

McKinney, Texas, 75069, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Bateman Horne Center

Salt Lake City, Utah, 84102, United States

Location

Metrodora Institute

West Valley City, Utah, 84119, United States

Location

Velocity Clinical Research - Hampton

Hampton, Virginia, 23666, United States

Location

VCU Health

Richmond, Virginia, 23219, United States

Location

Libin Cardiovascular Institute University of Calgary

Calgary, T2N 4Z6, Canada

Location

University of Alberta Hospital

Edmonton, T6G 2B7, Canada

Location

McGill University Health Centre

Québec, H4A 3J1, Canada

Location

Ciussse-Chus

Sherbrooke, J1H 5N4, Canada

Location

MeSH Terms

Interventions

Hizentra

Limitations and Caveats

The study was permanently terminated early by the sponsor because of recruitment difficulties due to stringent eligibility criteria relating to the participant's acute COVID-19 infection. Fewer than 10% of the planned number of participants were enrolled in the study and, consequently, no efficacy conclusions can be drawn due to the limited sample size and the fact that the premature discontinuation occurred at different study visits.

Results Point of Contact

• Title: Clinical Study Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

1-610-878-4697

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Period 1 (double-blind): Participant, Care Provider, Investigator, Outcomes Assessor Period 2 (open-label): No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 29, 2024
• Study Start: August 28, 2024
• Primary Completion: June 20, 2025
• Study Completion: July 11, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
• Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Locations

US (34); CA (4)