Evaluating IVIG for treating autonomic dysfunction in Long COVID
RECOVER-AUTONOMIC (IVIG): Randomized Trial of the Effect of IVIG Versus Placebo on Long COVID Symptoms
This study is testing whether a treatment called IVIG can help people with Long COVID who have symptoms like dizziness and rapid heartbeat feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | omalizumab, prednisone, immunotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06305793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with Long COVID who exhibit symptoms of autonomic dysfunction and meet specific inclusion criteria.
Not a fit: Patients who have previously received IVIG treatment or have contraindications to intravenous immunoglobulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients suffering from debilitating autonomic dysfunction due to Long COVID.
How similar studies have performed: Other studies have explored similar immune-mediated approaches for treating Long COVID symptoms, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.