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Can immune therapy IVIG calm long COVID's autonomic storm?

NCT ID NCT06305793

Disease control Sponsor: Kanecia Obie Zimmerman 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 1 time

Summary

This study tests whether intravenous immunoglobulin (IVIG) can reduce symptoms of autonomic dysfunction—such as dizziness, rapid heartbeat, and fatigue—in people with long COVID. Two hundred participants will receive either IVIG or a placebo (saline) for 9 months, plus coordinated non-drug care. The goal is to see if IVIG improves daily function and symptom severity.

What this could mean

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

Active substance
IVIG (intravenous immunoglobulin)
What this could lead to
If IVIG works, it could provide a treatment for autonomic symptoms like dizziness and rapid heart rate in long COVID patients.
What could go wrong
This is a Phase 2 trial with 200 participants, so results are preliminary. IVIG can cause side effects like headache, fever, or allergic reactions, and may not prove effective.

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

200 people

The number who actually took part.

Started

May 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study) Additional Appendix A (IVIG Sub-study) Level Inclusion Criteria: 1. Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms 2. COMPASS-31 Score \> 40 Exclusion Criteria: * See NCT06305780 for RECOVER-AUTO: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study) Additional Appendix A (IVIG Sub-study) Level Exclusion Criteria: 1. Current or previous IVIG treatment 2. Contraindication to intravenous immunoglobulin. 3. Known allergic reactions to blood products including IVIG and/or subcutaneous immunoglobulin (SCIG), such as history of clinically relevant hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severe generalized or severe local skin reactions 4. Selective IgA deficiency 5. Current and recent (within 5 half-lives) use of high-dose corticosteroids (for example for prior solid organ transplant), omalizumab, anti-TNF-alpha inhibitors 6. Use of immunosuppressants such as Plaquenil, or low-dose steroid (prednisone, no more than 10mg a day) will be excluded unless the participant is on stable (\>4 weeks) dose 7. Significant thrombotic events after the acute phase of COVID-19 and/or within 6 months of enrollment 8. Veins that are not viable for infusions 9. Not willing to adhere to dosing schedule for IVIG infusions for 9 months

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Conditions

The condition(s) this trial relates to.

COVID-19 dysautonomia long COVID-19 postural orthostatic tachycardia syndrome

As listed by the trial registrant

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

Long coronavirus disease 2019 (COVID19) Long COVID Long COVID-19

Contacts and locations

Locations

  • All sites listed under NCT06305780

    Durham, North Carolina, 27710, United States

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