RECOVER-AUTONOMIC Platform Protocol

Last updated: April 25, 2025
Sponsor: Kanecia Obie Zimmerman
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Treatment

IVIG Placebo + Coordinated Care

IVIG + Coordinated Care

IVIG + Usual Care

Clinical Study ID

NCT06305780
Pro00112597
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 PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years of age at the time of enrollment

  2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by thePan American Health Organization12ɸ ɸ Enrollment of participants with suspected orprobable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study DrugAppendix. Refer to the Manual of Procedures (MOP) for details. Suspected case of SARS-CoV-2 infection - Three options, A through C: A. Meets the clinical OR epidemiological criteria.

  3. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) ORAcute onset of ANY THREE OR MORE of the following signs or symptoms: fever,cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza,dyspnea, nausea, diarrhea, anorexia.

  4. Epidemiological criteria: Contact of a probable or confirmed case or linked toa COVID-19 cluster; or B. Presents with acute respiratory infection withhistory of fever or measured fever of ≥ 38°C; and cough; with onset within thelast 10 days; and who requires hospitalization); or C. Presents with noclinical signs or symptoms, NOR meeting epidemiologic criteria with a positiveprofessional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test. Probable case of SARS-CoV-2 infection, defined as meets clinical criteria above ANDis a contact of a probable or confirmed case or is linked to a COVID-19 cluster. Confirmed case of SARS-CoV-2 infection - Two options, A through B: A. A person with a positive nucleic acid amplification test, regardless of clinicalcriteria OR epidemiological criteria; or B. Meeting clinical criteria AND/ORepidemiological criteria (See suspect case A). With a positive professional use orself-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.

  5. Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >25) following aSARS-CoV-2 infection that has persisted for at least 12 weeks and is still presentat the time of consent

  6. OHQ/OIQ, question 1 score >2

Exclusion

Exclusion Criteria:

  1. Known pregnancy, breast-feeding, or contemplating pregnancy during the study period

  2. Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment

  3. Known renal failure (eGFR <20ml/1.73 m²)

  4. Known atrial fibrillation or significant cardiac arrhythmia

  5. Known cardiovascular conditions such as heart failure (Class 3-4), severe valvulardisease, symptomatic ischemic coronary artery disease, revascularization for PAD/CADwithin the past 6 months

  6. Clinically significant atherosclerotic disease, defined as history of stroke ormyocardial infarction or revascularization 6 months prior to enrollment and/orcurrent symptomatic angina

  7. Existing uncontrolled hypertension

  8. History of significant hypercoagulability disorders

  9. Active or recent thrombosis

Study Design

Total Participants: 380
Treatment Group(s): 8
Primary Treatment: IVIG Placebo + Coordinated 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

  • East Alabama Medical Center - Appendix A & B

    Opelika, Alabama 36801
    United States

    Active - Recruiting

  • East Alabama Medical Center - Appendix B Only

    Opelika, Alabama 36801
    United States

    Active - Recruiting

  • Center for Complex Neurology - Appendix A & B

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • University of Arkansas for Medical Sciences - Appendix A & B

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • University of California San Diego - Appendix A & B

    La Jolla, California 92307
    United States

    Active - Recruiting

  • University of California San Diego - Appendix B Only

    La Jolla, California 92307
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center - Appendix A & B

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Stanford University - Appendix A & B

    Stanford, California 94305
    United States

    Active - Recruiting

  • Stanford University - Appendix B Only

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • MedStar National Rehabilitation Hospital - Appendix B only

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • University of Florida Health - Appendix A & B

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Lakeland Regional Medical Center - Appendix A & B

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • Innovation Clinical Trials Inc.- Appendix A & B

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Morehouse School of Medicine - Appendix A & B

    Atlanta, Georgia 30310
    United States

    Active - Recruiting

  • Queens Medical Center - Appendix A & B

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Queens Medical Center - Appendix B Only

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Rush University Medical Center - Appendix A & B

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Rush University Medical Center - Appendix B Only

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Illinois at Chicago - Appendix A & B

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • NorthShore University HealthSystem - Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • NorthShore University HealthSystem - Evanston Hospital - Appendix B Only

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • University of Iowa - Appendix A & B

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center CTSU Fairway - Appendix A & B

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • University of Kentucky Medical Center - Appendix A & B

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University Medical Center New Orleans - Appendix A & B

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Johns Hopkins Hospital - Appendix A & B

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins Hospital - Appendix A Only

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Brigham and Women's Hospital - Appendix A & B

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham and Women's Hospital - Appendix A Only

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Henry Ford Hospital - Appendix A & B

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Mayo Clinic - Appendix A & B

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • University of Mississippi Medical Center - Appendix A & B

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Washington University School of Medicine - Appendix A & B

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine - Appendix B Only

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses Campus - Appendix A & B

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses Campus - Appendix B

    Bronx, New York 10467
    United States

    Active - Recruiting

  • University at Buffalo - Appendix A & B

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • St. Lawrence Health Medical Campus - Appendix A & B

    Canton, New York 13617
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center - Appendix A & B

    New York, New York 10032
    United States

    Active - Recruiting

  • Stony Brook University Hospital - Appendix A & B

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Duke University Hospital - Appendix A & B

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • East Carolina University - Appendix A & B

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • East Carolina University - Appendix B

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • East Carolina University - Appendix B Only

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Cleveland Clinic - Appendix A & B

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Oregon Health and Science University - Appendix A & B

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Kent Hospital - Appendix A & B

    Pawtucket, Rhode Island 02860
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • National Neuromuscular Research Institute - Appendix A & B

    Austin, Texas 78759
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute - Appendix B Only

    Austin, Texas 78759
    United States

    Site Not Available

  • Southwest Family Medicine Associates - Appendix A & B

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 78701
    United States

    Active - Recruiting

  • University of Texas Health Science Center at San Antonio - Appendix A & B

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Bateman Horne Center - Appendix B Only

    Salt Lake City, Utah 84102
    United States

    Active - Recruiting

  • Vermont Lung Center, University of Vermont - Appendix A & B

    Burlington, Vermont 05405
    United States

    Active - Recruiting

  • Vermont Lung Center, University of Vermont - Appendix B Only

    Burlington, Vermont 05405
    United States

    Active - Recruiting

  • University of Virginia Health System, University Hospital - Appendix A & B

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital - Appendix A & B

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital - Appendix A and B

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Evergreen Hospital Medical Center - Appendix A & B

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • Providence Medical Research Center - Appendix A & B

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Marshall Health - University Physicians and Surgeons - Appendix A & B

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

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