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Experimental drug for Post-COVID POTS study halted early

NCT ID NCT05918978

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of efgartigimod in adults with post-COVID postural orthostatic tachycardia syndrome (POTS), a condition causing rapid heart rate and dizziness upon standing. The trial was an open-label extension for people who completed a previous study. However, the study was terminated early, so only limited safety information is available from the 33 participants enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod
What this could lead to
If successful, this could point toward a treatment option for post-COVID POTS, a condition with few approved therapies.
What could go wrong
The study was terminated early with only 33 participants, so we have very limited data on safety and effectiveness. It is still unclear if efgartigimod helps POTS symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The participant has completed the ARGX-113-2104 study without permanent discontinuation of IMP and agrees to directly roll over into the extension study without discontinuation of IMP. 2. The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements. 3. The participant agrees to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraceptive requirements are provided. 4. Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. Exclusion Criteria: 1. The participant has a clinically significant condition, based on the judgement of the Study Investigator, eg, laboratory abnormalities, 12-lead ECG readings, concomitant medical disease(s), etc., which may place them at undue risk or confound interpretation of study data. 2. The participant intends to become pregnant or start breastfeeding during the study.

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Conditions

The condition(s) this trial relates to.

long COVID-19 post-COVID-19 disorder postural orthostatic tachycardia syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-COVID postural orthostatic tachycardia syndrome postural orthostatic tachycardia syndrome

Contacts and locations

Locations

  • Apex Trials Group

    Fort Worth, Texas, 76104, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Metrodora Institute

    West Valley City, Utah, 84119, United States

  • North Shore University HealthSystem

    Glenview, Illinois, 60026, United States

  • Pioneer Clinical Research

    Rosharon, Texas, 77583, United States

  • Standford Movement Disorder Center

    Palo Alto, California, 94304, United States

  • UC Sand Diego Sulpizio Cardiovascular Center

    La Jolla, California, 92037, United States

  • University Hospitals, Neurology Clinical Trials

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.