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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 11, 2024

Primary Completion Date

April 1, 2026

Study Completion Date

July 1, 2026

Conditions
Long COVIDLong 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.

Trial Locations (1)

27710

All sites listed under NCT06305780, Durham

All Listed Sponsors
lead

Kanecia Obie Zimmerman

OTHER