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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Kanecia Obie Zimmerman

  lead OTHER

Principal Investigators

• Christopher Grainger, MD · Duke Clinical Research Institute

• Cyndya Shibao, MD · Vanderbilt University Medical Center

• Peter Novak, MD · Harvard

• Pam Taub, MD · University of California, San Diego

• Tae Chung, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-11

Primary Completion

2026-04-01

Completion

2026-07-01

FDA Drug

Yes

Countries

• United States

Study Locations