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RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

RECOVER-AUTONOMIC (IVIG): Randomized Trial of the Effect of IVIG Versus Placebo on Long COVID Symptoms

NCT06305793•Kanecia Obie Zimmerman

Summary

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.

Detailed Description

The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms. Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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

Locations (1)

All sites listed under NCT06305780

Durham, North Carolina, United States

Key Dates

Start Date

March 11, 2024

Primary Completion Date

April 1, 2026

Completion Date

July 1, 2026

Last Updated

July 23, 2025

Enrollment

200

ACTUAL participants

Conditions

Long COVIDLong Coronavirus Disease 2019 (Covid19)Long Covid-19

Interventions

IVIG (intravenous immunoglobulin)

DRUG

IVIG Placebo

DRUG

Coordinated Care

BEHAVIORAL

Usual Care

BEHAVIORAL

Taurine Supplementation in Long COVID

NCT06721949

Long COVID

View study

RECRUITINGPHASE3

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

Inclusion Criteria

Exclusion Criteria

Taurine Supplementation in Long COVID

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome

Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome

A Study to Examine Anktiva for the Treatment of COVID-19.