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's side effects include piloerection, pruritus, and supine hypertension. Ivabradine can cause bradycardia, luminous phenomena (phosphenes), and atrial fibrillation. While specific side effects of FcRn inhibitors like Efgartigimod are not detailed, monitoring for immunogenicity and general tolerability is essential.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS). Treatments often involve off-label use of medications such as beta-blockers, fludrocortisone, and midodrine to manage symptoms. Efgartigimod, an FcRn inhibitor, is currently being studied for its efficacy in treating post-COVID-19 POTS, but it has not yet received FDA approval for this indication.

What other types of research exist?

As of 2024, promising novel alternatives to Efgartigimod for POTS patients include Ivabradine, which reduces heart rate without affecting blood pressure, and Droxidopa, which helps increase blood pressure and improve symptoms of orthostatic intolerance. Both have shown efficacy in clinical trials for managing POTS symptoms.

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Monoclonal Antibodies

Efgartigimod for Post-COVID 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

Be older than 18 years old

Must not have

Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening

History of or currently being treated for clinically significant ongoing cardiac arrhythmia, heart failure, myocarditis, pulmonary embolism, pulmonary fibrosis, or critical illness-related polyneuropathy or myopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 31 weeks

Summary

This trial is testing a medication called efgartigimod, which lowers specific antibodies, in people who have POTS after recovering from COVID-19. The goal is to see if it can help reduce their symptoms.

Who is the study for?

Adults who developed Postural Orthostatic Tachycardia Syndrome (POTS) after having COVID-19 can join this trial. They must have a BMI under 35, be able to follow the study rules, and use birth control as required. People with certain pre-existing conditions, ongoing serious infections or diseases like HIV or cancer in the last 3 years, recent major surgery, drug abuse history, or those pregnant cannot participate.

What is being tested?

The trial is testing Efgartigimod against a placebo to see if it's safe and effective for treating POTS symptoms that started after COVID-19. It will also look at how the body processes the drug and its impact on immune system responses.

What are the potential side effects?

Possible side effects of Efgartigimod are not detailed here but typically could include reactions where the drug is injected, flu-like symptoms, headaches, potential increased risk of infections due to immune system changes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled infections or a positive COVID-19 test.

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I have or am being treated for a serious heart or lung condition, or severe nerve/muscle disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 31 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 31 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 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

Evaluate the efficacy of efgartigimod in reducing the severity of post-COVID-19 POTS symptoms

Evaluate the safety and tolerability of efgartigimod in patients with post-COVID-19 POTS

Secondary study objectives

Assess the immunogenicity of efgartigimod

Assess the pharmacodynamic (PD) effect of efgartigimod

Assess the pharmacokinetic (PK) profile of efgartigimod

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EfgartigimodExperimental Treatment1 Intervention

Receive efgartigimod IV 10mg/kg during weekly infusions during a treatment period of 24 weeks

Group II: PlaceboPlacebo Group1 Intervention

Receive a matching placebo during weekly infusions during a treatment period of 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Efgartigimod

2022

Completed Phase 2

~130

0 / 2Eligibility 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

The most common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) include beta-blockers, which reduce heart rate and alleviate tachycardia symptoms, and fludrocortisone, which increases blood volume to prevent blood pooling. Efgartigimod, an FcRn inhibitor, is being studied for POTS due to its ability to reduce pathogenic autoantibodies, addressing the autoimmune component of some POTS cases. These treatments are essential as they target the underlying mechanisms of POTS, helping to manage symptoms and improve patient outcomes.

Distinctive Steady-State Heart Rate and Blood Pressure Responses to Passive Robotic Leg Exercise during Head-Up Tilt: A Pilot Study in Neurological Patients.Upper limb exercise effect on tilt tolerance during orthostatic training of patients with spinal cord injury.Effects of various countermeasures against the adverse effects of weightlessness on central circulation in the healthy man.