- 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.
Post-COVID Postural Orthostatic Tachycardia Syndrome
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
NCT06524739 | PHASE 3 | INTERVENTIONAL
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 \[post-COVID-POTS\]).
Trial Information
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University of Alabama Hospital at Birmingham
Birmingham,Alabama,United States,35294
Center for Complex Neurology, EDS & POTS
Phoenix,Arizona,United States,85006
Mayo Clinic Arizona
Scottsdale,Arizona,United States,85259
Arkansas Cardiology Clinic Little Rock
Little Rock,Arkansas,United States,72205
UC San Diego Health
La Jolla,California,United States,92037
University of california Irvine
Orange,California,United States,92868
National Jewish Health
Denver,Colorado,United States,80206
Velocity Clinical Research, Savannah
Savannah,Georgia,United States,31406
LSU Health Sciences Center
New Orleans,Louisiana,United States,70112
Johns Hopkins Hospital
Baltimore,Maryland,United States,21224
Velocity Clinical Research Lincoln
Lincoln,Nebraska,United States,68510
Dysautonomia Clinic
Buffalo,New York,United States,14221
South Shore Neurologic Associates
Patchogue,New York,United States,11772
Duke University Medical Center
Durham,North Carolina,United States,27710
University Hospital Cleveland Medical Center
Cleveland,Ohio,United States,44195
Penn Presbyterian Medical Center
Philadelphia,Pennsylvania,United States,19104
Vanderbilt University Medical Center
Nashville,Tennessee,United States,37232
UT Austin Dell Medical School
Austin,Texas,United States,78712
University of Texas Southwestern Medical Center
Dallas,Texas,United States,75390
Sunbeam Clinical Research
McKinney,Texas,United States,75069
University of Texas Health Science Center
San Antonio,Texas,United States,78229
Bateman Horne Center
Salt Lake City,Utah,United States,84102
Metrodora Institute
West Valley City,Utah,United States,84119
Libin Cardiovascular Institute University of Calgary
Calgary,Canada,T2N4Z6
University of Alberta Hospital
Edmonton,Canada,T6G2B7
McGill University Health Centre
Québec,Canada,H4A3J1
CiussseChus
Sherbrooke,Canada,J1H5N4
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov