NCT06305793CompletedPhase 2
RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)
RECOVER-AUTONOMIC (IVIG): Randomized Trial of the Effect of IVIG Versus Placebo on Long COVID Symptoms
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 4 Mar 2024
- Start date
- 8 May 2024
- Primary completion date
- 23 Mar 2026
- Lead sponsor
- Kanecia Obie Zimmerman
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06305793
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 200
- From 8 May 2024 to the primary completion date, 23 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous IVIG treatment
- Current and recent (within 5 half-lives) use of high-dose corticosteroids (for example for prior solid organ transplant), omalizumab, anti-TNF-alpha inhibitors
- 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
Other illness
- 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
- Significant thrombotic events after the acute phase of COVID-19 and/or within 6 months of enrollment
Other
- 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:
- Contraindication to intravenous immunoglobulin.
- Selective IgA deficiency
- Veins that are not viable for infusions
- Not willing to adhere to dosing schedule for IVIG infusions for 9 months
Who the study is looking for
- 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:
- 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
- COMPASS-31 Score \> 40
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All sites listed under NCT06305780 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.