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Monoclonal Antibodies

Efgartigimod for Post-COVID-19 POTS (POTS Trial)

Phase 2

Recruiting

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 56 weeks

Awards & highlights

POTS Trial Summary

This trial looks at how safe and effective a drug is for people with post-COVID-19 postural orthostatic tachycardia syndrome (POTS).

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.Check my eligibility

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.See study design

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.

POTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman who can have children and have a negative pregnancy test.

POTS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 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

Incidence and severity of AESIs.

Secondary outcome measures

Change from baseline to week 24 and 48 in the PROMIS Cognitive Function Short Form 6a

Change from baseline to week 24 and 48 in the PROMIS Fatigue Short Form 8a

Change from baseline to week 24 and week 48 in COMPASS 31 (modified)

+6 more

POTS 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

2021

Completed Phase 1

~40

0 / 1Eligibility criteria met

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

53 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Iqvia Pty LtdIndustry Sponsor

107 Previous Clinical Trials

170,030 Total Patients Enrolled

1 Trials studying Postural Orthostatic Tachycardia Syndrome

53 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

Efgartigimod (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05918978 — Phase 2

Postural Orthostatic Tachycardia Syndrome Research Study Groups: Efgartigimod

Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Efgartigimod Highlights & Side Effects. Trial Name: NCT05918978 — Phase 2

Efgartigimod (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05918978 — 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 Food and Drug Administration authorized Efgartigimod for commercial use?

"Given the lack of proof-of-concept data on Efgartigimod's efficacy, its safety score was a 2."

Answered by AI

To what degree is the research sample size expanding?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this study is actively searching for participants. It was initially posted on June 16th 2023 and has been amended as recently as June 22nd 2023. The trial requires 38 individuals to be recruited from one medical centre."

Answered by AI

Are there still available slots for participants in this research?

"Affirmative. Clinicaltrials.gov has verified that this medical trial is still recruiting participants, with an initial posting on June 16th 2023 and a recent edit from the 22nd of the same month. In total 38 patients will be recruited across 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS

2023. "Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918978.