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Monoclonal Antibodies

IgPro20 for POTS

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at week 25 and at week 53
Awards & highlights

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 \[post-COVID-POTS\]).

Who is the study for?
This trial is for individuals who have developed Postural Orthostatic Tachycardia Syndrome (POTS) following a SARS-CoV-2 infection. Participants should be experiencing symptoms like rapid heartbeat when standing up.
What is being tested?
The study is testing the effectiveness and safety of IgPro20, an immunoglobulin therapy, compared to a placebo in treating post-COVID-19 POTS. Patients are randomly assigned to receive either IgPro20 or a placebo without knowing which one they get.
What are the potential side effects?
Possible side effects of IgPro20 may include headache, nausea, reactions at the injection site, fever, fatigue, or allergic responses. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at week 25 and at week 53
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at week 25 and at week 53 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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])
Secondary study objectives
Change from baseline in COMPASS-31 total score
Change from baseline in ECG abnormalities
Change from baseline in heart rate increase within 10 minutes of standing test
+5 more

Side effects data

From 2018 Phase 4 trial • 49 Patients • NCT03033745
14%
Upper respiratory tract infection
7%
Trigeminal neuralgia
7%
Rash
7%
Vitamin D deficiency
7%
Injection site bruising
7%
Fatigue
7%
Hepatic enzyme increased
7%
Leukopenia
7%
Injection site swelling
7%
Injection site pain
7%
Hypotension
7%
Nasopharyngitis
7%
Tooth abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
IgPro20 (Manual Push Flow Rate) 120 mL/h
IgPro20 (Pump-assisted Volume) 25 mL
IgPro20 (Pump-assisted Volume) 40 mL
IgPro20 (Pump-assisted Volume) 50 mL
IgPro20 (Pump-assisted Flow Rate) 25 mL/h
IgPro20 (Pump-assisted Flow Rate) 50 mL/h
IgPro20 (Pump-assisted Flow Rate) 75 mL/h
IgPro20 (Pump-assisted Flow Rate) 100 mL/h
IgPro20 (Manual Push Flow Rate) 30 mL/h
IgPro20 (Manual Push Flow Rate) 60 mL/h

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IgPro20Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IgPro20
2008
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
197 Previous Clinical Trials
1,211,189 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,244 Previous Clinical Trials
505,486 Total Patients Enrolled
~118 spots leftby Feb 2027
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