NCT06305793

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Kanecia Obie Zimmerman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long COVID
• Long Coronavirus Disease 2019 (Covid19)
• Long Covid-19

Interventions

Type	Name	Description
DRUG	IVIG (intravenous immunoglobulin)	Participants will receive IVIG for 9 months (36 weeks) with a follow-up period for an additional 3 months (total study duration for 12 months).
DRUG	IVIG Placebo	Normal saline given intravenously will be the control (placebo) product. Blinding IV bag and tubing covers will be used for both IVIG and Placebo. Participants will receive placebo for 9 months (36 weeks) with a follow-up period for an additional 3 months (total study duration for 12 months).
BEHAVIORAL	Coordinated Care	Participants will receive coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
BEHAVIORAL	Usual Care	Participants will receive usual non-pharmacologic care (control) for a duration of 3 months, concurrent with IVIG administration.

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2024-03-12
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study