Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
- Conditions
- Post-COVID Postural Orthostatic Tachycardia Syndrome
- Interventions
- Biological: Placebo
- Registration Number
- NCT06524739
- Lead Sponsor
- CSL Behring
- 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 \[post-COVID-POTS\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 177
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - IgPro20 IgPro20 -
- Primary Outcome Measures
Name Time Method 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]) At screening, and at week 25
- Secondary Outcome Measures
Name Time Method Change from baseline in orthostatic intolerance score of COMPASS-31 At baseline and at week 25 The Composite Autonomic Symptom Score 31 (COMPASS-31) is a self-reported questionnaire that measures autonomic symptoms related to 6 domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The treatment effect of interest is differences from baseline in the orthostatic intolerance score of COMPASS-31.
Change from baseline in COMPASS-31 total score At baseline and at week 25 The COMPASS-31 is a self-reported questionnaire that measures autonomic symptoms related to 6 domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. This questionnaire generates a weighted score from 0 to 100, with higher scores representing higher symptom burden.
Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs After treatment, for up to 57 weeks Percentage of participants with ECG abnormalities At baseline, at Week 25 and at Week 53 Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs After treatment, for up to 57 weeks Number of participants with electrocardiogram (ECG) abnormalities At baseline, at Week 25 and at Week 53 Change from baseline in heart rate increase within 10 minutes of standing test At baseline and at Week 25 Change from baseline in ECG abnormalities At baseline, at Week 25 and at Week 53
Trial Locations
- Locations (38)
Sunbeam Clinical Research
🇺🇸McKinney, Texas, United States
Hope Research Network
🇺🇸Miami, Florida, United States
Well Pharma Medical Research, Corp
🇺🇸Miami, Florida, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
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
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
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Bateman Horne Center
🇺🇸Salt Lake City, Utah, United States
Metrodora Institute
🇺🇸West Valley City, Utah, United States
Velocity Clinical Research - Hampton
🇺🇸Hampton, Virginia, United States
VCU Health
🇺🇸Richmond, Virginia, United States
Libin Cardiovascular Institute University of Calgary
🇨🇦Calgary, Canada
University of Alberta Hospital
🇨🇦Edmonton, Canada
McGill University Health Centre
🇨🇦Québec, Canada
Ciussse-Chus
🇨🇦Sherbrooke, Canada
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
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
UT Austin Dell Medical School
🇺🇸Austin, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Prolato Clinical Research Center
🇺🇸Houston, Texas, United States