Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS

Keywords

• POTS

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Study arms

• Experimental
  IgPro20

  Biological: IgPro20

• Placebo comparator
  Placebo

  Biological: Placebo

Interventions

• BiologicalIgPro20

  IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration

  Also known as: HIZENTRA®

• BiologicalPlacebo

  2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.

Primary outcomes

1. 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.

   Time frame: At Baseline and at Week 25

Secondary outcomes

1. 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.

   Time frame: At Baseline and at Week 25

2. 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.

   Time frame: At Baseline and at Week 25

3. 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.

   Time frame: At Baseline and at Week 25

4. Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE

   Time frame: Up to Week 45

5. Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE

   The participant data were rounded to one decimal place.

   Time frame: Up to Week 45

6. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

   Time frame: Up to Week 45

7. Percentage of Participants With Clinically Significant ECG Abnormalities

   Time frame: Up to Week 45

8. Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities

   Time frame: From Baseline up to Week 45

9. Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities

   Time frame: From Baseline up to Week 45

Baseline characteristics

Study documents

• Study protocol · Apr 24, 2024
• Statistical analysis plan · Aug 27, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap