Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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]).

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)

Keywords

Post-COVID Postural Orthostatic Tachycardia Syndrome, POTS, Postural Orthostatic Tachycardia Syndrome, Tachycardia, Syndrome, IgPro20

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Locations

  • UC San Diego Health not yet accepting patients
    La Jolla California 92037 United States
  • University of california Irvine not yet accepting patients
    Orange California 92868 United States
  • Sunbeam Clinical Research accepting new patients
    McKinney Texas 75069 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT06524739
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 177 study participants
Last Updated