Post-COVID Postural Orthostatic Tachycardia SyndromePhase 3NCT06524739
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
A Phase 3 study testing IgPro20 in people with Post-COVID Postural Orthostatic Tachycardia Syndrome, run by CSL Behring at 38 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- IgPro20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 38 sitesin 2 countries
- Study dates
- 28 Aug 2024to 11 Jul 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States34 sites
UT Austin Dell Medical School
Austin, Texas, 78712
Johns Hopkins Bayview Medical Center PMR
Baltimore, Maryland, 21224
Mass General Brigham (Massachusetts General Hospital)
Belmont, Massachusetts, 02478
University of Alabama Hospital at Birmingham
Birmingham, Alabama, 35294-1152
Dysautonomia Clinic
Buffalo, New York, 14221
Bernstein Clinical Research Center
Cincinnati, Ohio, 45236
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Profound Research LLC at Millennium Affiliated Physicians
Farmington Hills, Michigan, 48334
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666
Prolato Clinical Research Center
Houston, Texas, 77054
UC San Diego Health
La Jolla, California, 92037
Velocity Clinical Research - Lincoln
Lincoln, Nebraska, 68510
Arkansas Cardiology Clinic - Little Rock
Little Rock, Arkansas, 72205
Sunbeam Clinical Research
McKinney, Texas, 75069
Hope Research Network
Miami, Florida, 33166
Well Pharma Medical Research, Corp
Miami, Florida, 33173
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Velocity Clinical Research, Metairie
New Orleans, Louisiana, 70119
Hightower Clinical
Oklahoma City, Oklahoma, 73134
University of california Irvine
Orange, California, 92868
NYU Langone Health South Shore Neurologic Associates
Patchogue, New York, 11772
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Center for Complex Neurology, EDS & POTS
Phoenix, Arizona, 85006
VCU Health
Richmond, Virginia, 23219
Bateman Horne Center
Salt Lake City, Utah, 84102
University of Texas Health Science Center
San Antonio, Texas, 78229
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Velocity Clinical Research - Union
Union, South Carolina, 29379
Metrodora Institute
West Valley City, Utah, 84119
Canada4 sites
Libin Cardiovascular Institute University of Calgary
Calgary, T2N 4Z6
University of Alberta Hospital
Edmonton, T6G 2B7
McGill University Health Centre
Québec, H4A 3J1
Ciussse-Chus
Sherbrooke, J1H 5N4
About this study
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)
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]).
- Being tested
- IgPro20, Placebo
- Keywords
- POTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgPro20Biological
Also called HIZENTRA®
IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration
PlaceboBiological
2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.
| Study group | Role | What they receive |
|---|---|---|
| IgPro20 | Experimental | Not described Receives: Biological: IgPro20 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Baseline and at Week 25
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: At Baseline and at Week 25
Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE
Measured: 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.
Measured: Up to Week 45
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Measured: Up to Week 45
Percentage of Participants With Clinically Significant ECG Abnormalities
Measured: Up to Week 45
Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities
Measured: From Baseline up to Week 45
Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities
Measured: From Baseline up to Week 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start28 Aug 2024
- Primary completion20 Jun 2025
- Study completion11 Jul 2025
Why it stopped: Sponsor decision, not for safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-COVID Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524739
- Sponsor's protocol ID
- IgPro20_3010
- Other IDs
- 2023-508744-22-00, 2023
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2024
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06524739
- Acronym / sponsor ID
- IgPro20_3010
- Keywords
- POTS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, not for safety reasons.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgPro20 | Experimental | Biological: IgPro20 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgPro20Also: HIZENTRA®IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration | Biological | IgPro20 |
| Placebo2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP. | Biological | Placebo |
Primary outcome
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])
Time frame: At Baseline and at Week 25
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.
9 secondary outcomes
Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)
Time frame: At Baseline and at Week 25
Change From Baseline in COMPASS-31 Total Score
Time frame: At Baseline and at Week 25
Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSL Behring
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IgPro20 in people with Post-COVID Postural Orthostatic Tachycardia Syndrome, run by CSL Behring at 38 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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]) (time frame: At Baseline and at Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.