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

CSL Behring

Status and phase: Enrolling; Phase 3

Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome

Treatments: Biological: IgPro20; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06524739

2023-508744-22-00 (EU Trial (CTIS) Number)

IgPro20_3010

Details and patient eligibility

About

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]).

Enrollment: 177 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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177 participants in 2 patient groups, including a placebo group

IgPro20

Experimental group

Treatment:

Biological: IgPro20

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo