Efgartigimod for Post-COVID POTS
(POTS Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial requires participants to stay on a stable regimen of medications during the study, so you should not stop taking your current medications.
What data supports the effectiveness of the drug Efgartigimod for treating post-COVID POTS?
There is no direct evidence from the provided research articles about the effectiveness of Efgartigimod for treating post-COVID POTS. However, since POTS may have an immune-mediated component, and Efgartigimod is known to modulate the immune system, it could potentially be beneficial, similar to how intravenous immunoglobulin (IVIG) has been used in immune-mediated POTS cases.12345
How is the drug Efgartigimod unique for treating Post-COVID POTS?
Efgartigimod is unique because it is designed to modulate the immune system by targeting antibodies, which may help in conditions like Post-COVID POTS where the immune system is thought to play a role. Unlike other treatments that might focus on symptoms, Efgartigimod's approach is to address the underlying immune response.678910
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly infusions of efgartigimod or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Efgartigimod
- Placebo
Efgartigimod is already approved in European Union, United States, Canada, Japan for the following indications:
- Generalized Myasthenia Gravis (gMG)
- Generalized Myasthenia Gravis (gMG)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Generalized Myasthenia Gravis (gMG)
- Generalized Myasthenia Gravis (gMG)
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University
Iqvia Pty Ltd
Industry Sponsor
Ari Bousbib
Iqvia Pty Ltd
Chief Executive Officer since 2016
MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris
Jeffrey Spaeder
Iqvia Pty Ltd
Chief Medical Officer
MD