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 \[post-COVID-POTS\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
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.
Time frame: At Baseline and at Week 25
Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)
The COMPASS-31 was a self-reported questionnaire that measures autonomic symptoms across six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. The OI domain assesses symptoms including faintness, dizziness, feeling "goofy," or had difficulty thinking soon after standing up from a sitting or lying position, and generates a total score ranging from 0 to 40 with higher scores representing a higher symptom burden. The treatment effect of interest was the difference from baseline in OI score of COMPASS-31. A more negative change from baseline indicates a greater improvement in OI symptoms.
Time frame: At Baseline and at Week 25
Change From Baseline in COMPASS-31 Total Score
The COMPASS-31 was a self-reported questionnaire that measured autonomic symptoms related to six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. This questionnaire generated a weighted score ranging from 0 to 100, with higher scores representing a higher symptom burden. A COMPASS-31 score of \>=40 indicated that participants had severe autonomic dysfunction. A more negative change from baseline indicates a greater improvement in autonomic symptoms.
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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
...and 28 more locations
Time frame: At Baseline and at Week 25
Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test
Heart rate for the standing test was measured at the end of 10 minutes in the supine position and at 1, 3, 5, 7, and 10 minutes of standing. The change in heart rate during the standing test was calculated as the difference between the average of the two highest heart rate measurements (bpm) within 10 minutes of standing and the heart rate measurement (bpm) at the end of 10 minutes in the supine position.
Time frame: At Baseline and at Week 25
Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE
Time frame: Up to Week 45
Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE
The participant data were rounded to one decimal place.
Time frame: Up to Week 45
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: Up to Week 45
Percentage of Participants With Clinically Significant ECG Abnormalities
Time frame: Up to Week 45
Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities
Time frame: From Baseline up to Week 45
Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities
Time frame: From Baseline up to Week 45