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Purpose

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]).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Period 1 (double-blind): Participant, Care Provider, Investigator, Outcomes Assessor Period 2 (open-label): No masking

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IgPro20
  • Biological: IgPro20
    IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration
    Other names:
    • HIZENTRA®
Placebo Comparator
Placebo
  • Biological: Placebo
    2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.

Recruiting Locations

Center for Complex Neurology, EDS & POTS
Phoenix, Arizona 85006
Contact:
Central Contact

Arkansas Cardiology Clinic - Little Rock
Little Rock, Arkansas 72205
Contact:
Central Contact

Sunbeam Clinical Research
McKinney, Texas 75069
Contact:
Use Central Contact

Metrodora Institute
West Valley City, Utah 84119
Contact:
Central Contact

More Details

NCT ID
NCT06524739
Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
+1 610-878-4697
clinicaltrials@cslbehring.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.