NCT06524739

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[post-COVID-POTS\]).

Conditions

• Post-COVID Postural Orthostatic Tachycardia Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	IgPro20	IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration
BIOLOGICAL	Placebo	2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP.

Timeline

• Start date: 2024-08-28
• Primary completion: 2025-06-20
• Completion: 2025-07-11
• First posted: 2024-07-29
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

38 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study