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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
Reached the age of consent when signing the informed consent form
Diagnosed with new-onset POTS post-COVID-19 established by specific criteria including history of COVID-19, tilt table or orthostatic vital sign measurements, ongoing symptoms of POTS, and COMPASS 31 score
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 weeks
Awards & highlights

POTS Trial Summary

This trial will explore the effects of a drug on post-COVID POTS symptoms, and evaluate its safety, effectiveness, and more.

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.Check my eligibility
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.See study design
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.

POTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am of legal age to make my own health decisions.
Select...
I was diagnosed with POTS after having COVID-19, confirmed by tests and ongoing symptoms.

POTS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Assess the immunogenicity of efgartigimod
Assess the pharmacodynamic (PD) effect of efgartigimod
Assess the pharmacokinetic (PK) profile of efgartigimod
+1 more

POTS 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
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
9,217 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
38 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,955 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
38 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Efgartigimod for commercial availability?

"Our evaluators concluded that Efgartigimod received a safety rating of 2 due to the availability of some data indicating its safety, but not yet having any evidence demonstrating clinical efficacy."

Answered by AI

How many enrollees has this clinical experiment attracted thus far?

"Affirmative. Evidence on clinicaltrials.gov demonstrates that this trial, which was initially posted in September 23rd 2022, is still looking for participants. 42 individuals must be recruited from 1 medical site to complete the research."

Answered by AI

Is this trial recruiting participants at the moment?

"Affirmative. According to clinicaltrials.gov, the trial which was first posted on September 23rd 2022 is currently seeking participants. 42 subjects need to be recruited from a single medical facility for this study."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Johns Hopkins University
Apex Trials Croup, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
2022. "Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633407.
~3 spots leftby Jun 2024
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