What side effects are associated with this type of intervention?

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) include beta-blockers, fludrocortisone, midodrine, and ivabradine. Beta-blockers can cause fatigue, cold extremities, and bradycardia. Fludrocortisone may lead to hypertension, hypokalemia, and fluid retention. Midodrine can cause piloerection, pruritus, and supine hypertension. Ivabradine may result in bradycardia, luminous phenomena, and hypertension. Efgartigimod, a Neonatal Fc Receptor (FcRn) antagonist under investigation, may have side effects related to immune modulation, but specific side effects are still being studied.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS). Treatment typically involves off-label use of medications such as beta-blockers, fludrocortisone, and midodrine to manage symptoms. Efgartigimod, a Neonatal Fc Receptor (FcRn) antagonist, is currently being studied for its potential use in POTS, but it has not yet received FDA approval for this indication. The focus of current research is on understanding its efficacy and safety in managing POTS symptoms.

What other types of research exist?

Promising novel alternatives to Efgartigimod for POTS patients include: 1) Ivabradine, which reduces heart rate by inhibiting the If current in the sinoatrial node, and 2) Droxidopa, a norepinephrine precursor that can help manage symptoms of orthostatic intolerance. Both have shown efficacy in managing symptoms of POTS and are being considered for broader use.

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Monoclonal Antibodies

Efgartigimod for Post-COVID-19 POTS (POTS Trial)

Phase 2

Waitlist Available

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 55 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing efgartigimod, a medication given through an IV drip, in adults with post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS). The goal is to see if it is safe and effective. Efgartigimod works by calming down parts of the immune system that might be causing issues in these patients.

Who is the study for?

This trial is for adults who have had COVID-19 and now suffer from Postural Orthostatic Tachycardia Syndrome (POTS), causing rapid heartbeat when standing. Participants must have finished a previous efgartigimod study, not be planning pregnancy or breastfeeding, agree to use contraception, and sign consent forms.

What is being tested?

The trial tests the safety and effectiveness of a drug called efgartigimod in treating POTS symptoms following COVID-19. It will also look at how the body processes the drug and its impact on the immune system over time.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to the immune system's response to efgartigimod, as well as any general medication-related side effects such as nausea, headaches, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 55 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 55 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of AESIs.

Secondary study objectives

Change from baseline to week 24 and week 48 in COMPASS 31 (modified)

Change from baseline to week 24 and week 48 in MaPS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EfgartigimodExperimental Treatment1 Intervention

Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Efgartigimod

2022

Completed Phase 2

~130

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Postural Orthostatic Tachycardia Syndrome (POTS) is commonly treated with medications that target the autonomic nervous system to improve blood flow and reduce heart rate. Beta-blockers, such as propranolol, work by slowing the heart rate and reducing the heart's workload. Fludrocortisone, a mineralocorticoid, helps increase blood volume by promoting sodium retention. Midodrine, an alpha-1 agonist, causes vasoconstriction, which helps prevent blood from pooling in the lower extremities. Efgartigimod, a Neonatal Fc Receptor (FcRn) antagonist, is being studied for its potential to modulate the immune system by reducing pathogenic IgG antibodies, which may play a role in autoimmune forms of POTS. These treatments are crucial for POTS patients as they address the underlying dysregulation of blood flow and heart rate, improving symptoms and quality of life.

Propylbenzilylcholine mustard-sensitive and -resistant muscarinic receptors in cardiac muscle.Chlorpromazine methiodide-induced barrel rotation: an antimuscarinic effect.[Use of transdermal scopolamine in the prevention of neuro-cardiogenic syncope induced by the tilt test].