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Evaluating IgPro20 for treating post-COVID POTS

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)

PHASE3 · CSL Behring · NCT06524739

This study is testing if a new treatment called IgPro20 can help people who have developed postural orthostatic tachycardia syndrome (POTS) after having COVID-19 feel better.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment177 (estimated)
Ages18 Years and up
SexAll
SponsorCSL Behring (industry)
Locations38 sites (Birmingham, Alabama and 37 other locations)
Trial IDNCT06524739 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial is a multicenter, double-blind, randomized, placebo-controlled study aimed at assessing the efficacy and safety of IgPro20 in patients diagnosed with post-COVID-19 postural orthostatic tachycardia syndrome (POTS). Participants must have a confirmed history of COVID-19 and develop POTS symptoms within four months post-infection. The study will involve administering either IgPro20 or a placebo to evaluate the treatment's pharmacokinetics and overall effectiveness in alleviating symptoms associated with POTS. The trial will adhere to strict eligibility criteria to ensure the safety and reliability of the results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with post-COVID POTS within four months of a confirmed COVID-19 infection.

Not a fit: Patients who had symptoms of POTS prior to their COVID-19 infection or have received certain treatments like immunoglobulin G within the last 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from post-COVID POTS.

How similar studies have performed: While this specific approach is novel, similar studies investigating treatments for POTS have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome, POTS

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.