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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
Awards & highlights

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:
Select...
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 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

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.

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
67 Previous Clinical Trials
10,321 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
33 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Iqvia Pty LtdIndustry Sponsor
112 Previous Clinical Trials
173,580 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
33 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

Postural Orthostatic Tachycardia Syndrome Research Study Groups: Placebo, Efgartigimod
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Efgartigimod Highlights & Side Effects. Trial Name: NCT05633407 — Phase 2
~18 spots leftby Sep 2025
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