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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
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 belowSelect...
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
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
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
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].
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].
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
67 Previous Clinical Trials
10,342 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
53 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Iqvia Pty LtdIndustry Sponsor
115 Previous Clinical Trials
174,421 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
53 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Efgartigimod
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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