Status:
TERMINATED
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
Lead Sponsor:
CSL Behring
Conditions:
Post-COVID Postural Orthostatic Tachycardia Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06524739
Start Date
August 28 2024
End Date
July 11 2025
Last Update
August 8 2025
Active Locations (38)
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1
University of Alabama Hospital at Birmingham
Birmingham, Alabama, United States, 35294-1152
2
Center for Complex Neurology, EDS & POTS
Phoenix, Arizona, United States, 85006
3
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
4
Arkansas Cardiology Clinic - Little Rock
Little Rock, Arkansas, United States, 72205