Clinical trial NCT06524739: Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
Official title: Double-blind, Randomized, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of IgPro20 (Subcutaneous Immunoglobulin, HIZENTRA®) in Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome
Keywords: POTS
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[post-COVID-POTS\]).


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. 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

Primary outcomes:
measure: 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])
timeFrame: At screening, and at week 25
Secondary outcomes:
measure: Change from baseline in orthostatic intolerance score of COMPASS-31
timeFrame: At baseline and at week 25
measure: Change from baseline in COMPASS-31 total score
timeFrame: At baseline and at week 25
measure: Change from baseline in heart rate increase within 10 minutes of standing test
timeFrame: At baseline and at Week 25
measure: Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs
timeFrame: After treatment, for up to 57 weeks
measure: Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs
timeFrame: After treatment, for up to 57 weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: At baseline, at Week 25 and at Week 53
measure: Percentage of participants with ECG abnormalities
timeFrame: At baseline, at Week 25 and at Week 53
measure: Change from baseline in ECG abnormalities
timeFrame: At baseline, at Week 25 and at Week 53
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Center for Complex Neurology, EDS & POTS
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology Clinic - Little Rock
state: Arkansas
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: Orange
country: United States
facility: University of california Irvine
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Miami
country: United States
facility: Hope Research Network
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Velocity Clinical Research, Metairie
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center PMR
state: Maryland
city: Belmont
country: United States
facility: Mass General Brigham (Massachusetts General Hospital)
state: Massachusetts
city: Farmington Hills
country: United States
facility: Profound Research LLC at Millennium Affiliated Physicians
state: Michigan
city: Lincoln
country: United States
facility: Velocity Clinical Research - Lincoln
state: Nebraska
city: Buffalo
country: United States
facility: Dysautonomia Clinic
state: New York
city: Patchogue
country: United States
facility: NYU Langone Health South Shore Neurologic Associates
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Union
country: United States
facility: Velocity Clinical Research - Union
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: UT Austin Dell Medical School
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: McKinney
country: United States
facility: Sunbeam Clinical Research
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: Bateman Horne Center
state: Utah
city: West Valley City
country: United States
facility: Metrodora Institute
state: Utah
city: Hampton
country: United States
facility: Velocity Clinical Research - Hampton
state: Virginia
city: Richmond
country: United States
facility: VCU Health
state: Virginia
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute University of Calgary
city: Edmonton
country: Canada
facility: University of Alberta Hospital
city: Québec
country: Canada
facility: McGill University Health Centre
city: Sherbrooke
country: Canada
facility: Ciussse-Chus
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: