Evaluating IVIG for treating autonomic dysfunction in Long COVID

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This platform protocol is designed to assess various interventions for autonomic dysfunction symptoms in individuals suffering from Long COVID. It is a multi-center, randomized, controlled trial that will evaluate both pharmacologic therapies, such as intravenous immunoglobulin (IVIG), and non-pharmacologic care. The study aims to determine if immune-mediated therapies can improve symptoms like postural orthostatic tachycardia syndrome (POTS) in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). Additional interventions may be added to the protocol as needed.

Why it matters

Who can join: the full rules

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

Where it's running

• All sites listed under NCT06305780
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Orshi Moy
• Email: recoverresearch@duke.edu
• Phone: 919-668-8060

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anktiva for treating Long COVID symptoms

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• Rehabilitation program to reduce fatigue after COVID-19

  This study is testing a new rehabilitation program called COVIDEx to see if it can help people with Long COVID feel less tired compared to standard care.

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• Whole-body Cryotherapy for Fatigue in ME/CFS, Fibromyalgia, Long COVID

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• Fatigue Investigation Using Digital Outcomes

  This study tests whether digital monitoring with a smartphone app and wearables can track fatigue in people with MS or long COVID, compared with healthy volunteers.

  Recruiting at 6 sites University of Zurich · Basel, Basel and 5 other locations · NCT07783074

• Biomarker study to understand Long COVID using VIPER

  This study tests biomarkers in people with Long COVID and those who recovered from COVID-19 to see how they can diagnose and track the condition over time.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07770022

• PERCEIVE-Outreach: A scalable care model to help people with Long COVID manage heart and lung symptoms

  This study tests a remote care model to see if a personalized, telehealth-based exercise program helps adults with Long COVID feel better and move more.

  Recruiting University of Tasmania · Hobart, Tasmania and 1 other locations · NCT07661862

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.