Clinical trial

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

Name

Pro00112597_A

Description

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.

Trial arms

Trial start

2024-03-11

Estimated PCD

2025-12-01

Trial end

2026-03-01

Phase

Early phase I

Treatment

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).

Arms:

IVIG + Coordinated Care, IVIG + Usual Care

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).

Arms:

IVIG Placebo + Coordinated Care, IVIG Placebo + Usual Care

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.

Arms:

IVIG + Coordinated Care, IVIG Placebo + Coordinated Care

Usual Care

Participants will receive usual non-pharmacologic care (control) for a duration of 3 months, concurrent with IVIG administration.

Arms:

IVIG + Usual Care, IVIG Placebo + Usual Care

Size

200

Primary endpoint

Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score

Baseline to End of Intervention (9 months)

Eligibility criteria

Inclusion Criteria: * 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: 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: * 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: 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2024-04-08

1 organization

1 product

3 indications

Organization

Kanecia Obie Zimmerman

Product

Indication

Indication

Indication