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

Last updated: June 26, 2024
Sponsor: Kanecia Obie Zimmerman
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Treatment

Usual Care

Coordinated Care

IVIG (intravenous immunoglobulin)

Clinical Study ID

NCT06305793
Pro00112597_A
OTA-21-015G
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria whichapplies 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 (anincrease of 30 beats per minute (bpm) or more in HR within 10 minutes upon standingwithout orthostatic hypotension) and experiencing orthostatic symptoms

  2. COMPASS-31 Score > 40

Exclusion

Exclusion Criteria:

  • See NCT06305780 for RECOVER-AUTO: Platform Protocol level exclusion criteria whichapplies 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 subcutaneousimmunoglobulin (SCIG), such as history of clinically relevant hemolysis after IVIGinfusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severegeneralized or severe local skin reactions

  4. Selective IgA deficiency

  5. Current and recent (within 5 half-lives) use of high-dose corticosteroids (forexample for prior solid organ transplant), omalizumab, anti-TNF-alpha inhibitors

  6. Use of immunosuppressants such as Plaquenil, or low-dose steroid (prednisone, nomore than 10mg a day) will be excluded unless the participant is on stable (>4weeks) dose

  7. Significant thrombotic events after the acute phase of COVID-19 and/or within 6months of enrollment

  8. Veins that are not viable for infusions

  9. Not willing to adhere to dosing schedule for IVIG infusions for 9 months

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: Usual Care
Phase: 2
Study Start date:
March 11, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • All sites listed under NCT06305780

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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