Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
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
- Post-COVID Postural Orthostatic Tachycardia Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IgPro20 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Center for Complex Neurology, EDS & POTS
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Contact:
Central Contact
Central Contact
Arkansas Cardiology Clinic - Little Rock
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Central Contact
Central Contact
National Jewish Health
Denver, Colorado 80206
Denver, Colorado 80206
Contact:
Central Contact
Central Contact
Velocity Clinical Research, Savannah
Savannah, Georgia 31406
Savannah, Georgia 31406
Contact:
Central Contact
Central Contact
Velocity Clinical Research - Lincoln
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Contact:
Central Contact
Central Contact
Dysautonomia Clinic
Buffalo, New York 14221
Buffalo, New York 14221
Contact:
Central Contact
Central Contact
UT Austin Dell Medical School
Austin, Texas 78712
Austin, Texas 78712
Contact:
Central Contact
Central Contact
Sunbeam Clinical Research
McKinney, Texas 75069
McKinney, Texas 75069
Contact:
Use Central Contact
Use Central Contact
Bateman Horne Center
Salt Lake City, Utah 84102
Salt Lake City, Utah 84102
Contact:
Central Contact
Central Contact
Metrodora Institute
West Valley City, Utah 84119
West Valley City, Utah 84119
Contact:
Central Contact
Central Contact
More Details
- NCT ID
- NCT06524739
- Status
- Recruiting
- Sponsor
- CSL Behring