RECOVER-AUTONOMIC Platform Protocol

Last updated: February 18, 2026
Sponsor: Kanecia Obie Zimmerman
Overall Status: Completed

Phase

2

Condition

Covid-19

Treatment

IVIG + Coordinated Care

IVIG + Usual Care

IVIG Placebo + 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 >20) 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

  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. Inability to comply with the protocol

  9. Any condition that the investigator believes makes it inappropriate to treat withstudy intervention, including severe debility.

  10. History of POTS or significant dysautonomia before COVID-19 index infection

  11. Enrolled in another clinical trial or another study intervention appendix in thisplatform protocol * Patients who are a part of observational studies (e.g. imaging)may be included in this trial. Participants may enroll in another interventionaltrial or re-enroll in this trial for a different study intervention appendix 30 daysafter end of study (Follow-up visit).

Study Design

Total Participants: 381
Treatment Group(s): 8
Primary Treatment: IVIG + Coordinated Care
Phase: 2
Study Start date:
March 11, 2024
Estimated Completion Date:
July 09, 2025

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

    Site Not Available

  • East Alabama Medical Center - Appendix B Only

    Opelika 4081644, Alabama 4829764 36801
    United States

    Site Not Available

  • Center for Complex Neurology - Appendix A & B

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Center for Complex Neurology - Appendix A & B

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Site Not Available

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

    Little Rock, Arkansas 72205
    United States

    Site Not Available

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

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • 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

    Site Not Available

  • Cedars Sinai Medical Center - Appendix A & B

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford University - Appendix A & B

    Stanford, California 94305
    United States

    Active - Recruiting

  • Stanford University - Appendix B Only

    Stanford, California 94305
    United States

    Site Not Available

  • University of California San Diego - Appendix B Only

    La Jolla 5363943, California 5332921 92307
    United States

    Site Not Available

  • Cedars Sinai Medical Center - Appendix A & B

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Stanford University - Appendix B Only

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

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

    Aurora, Colorado 80045
    United States

    Site Not Available

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

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • MedStar National Rehabilitation Hospital - Appendix B only

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar National Rehabilitation Hospital - Appendix B only

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • University of Florida Health - Appendix A & B

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Lakeland Regional Medical Center - Appendix A & B

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Innovation Clinical Trials Inc.- Appendix A & B

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • University of Florida Health - Appendix A & B

    Gainesville 4156404, Florida 4155751 32610
    United States

    Site Not Available

  • Lakeland Regional Medical Center - Appendix A & B

    Lakeland 4161438, Florida 4155751 33805
    United States

    Site Not Available

  • Innovation Clinical Trials Inc.- Appendix A & B

    Palmetto Bay 4167634, Florida 4155751 33157
    United States

    Site Not Available

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

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Morehouse School of Medicine - Appendix A & B

    Atlanta, Georgia 30310
    United States

    Site Not Available

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

    Atlanta 4180439, Georgia 4197000 30303
    United States

    Site Not Available

  • Morehouse School of Medicine - Appendix A & B

    Atlanta 4180439, Georgia 4197000 30310
    United States

    Site Not Available

  • Queens Medical Center - Appendix A & B

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Queens Medical Center - Appendix B Only

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Queens Medical Center - Appendix B Only

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Site Not Available

  • 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

    Site Not Available

  • University of Illinois at Chicago - Appendix A & B

    Chicago, Illinois 60612
    United States

    Site Not Available

  • 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

    Site Not Available

  • Rush University Medical Center - Appendix B Only

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • University of Illinois at Chicago - Appendix A & B

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • NorthShore University HealthSystem - Evanston Hospital - Appendix B Only

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • University of Iowa - Appendix A & B

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa - Appendix A & B

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

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

    Fairway, Kansas 66205
    United States

    Site Not Available

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

    Fairway 4271358, Kansas 4273857 66205
    United States

    Site Not Available

  • University of Kentucky Medical Center - Appendix A & B

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Medical Center - Appendix A & B

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • University Medical Center New Orleans - Appendix A & B

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University Medical Center New Orleans - Appendix A & B

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Site Not Available

  • Johns Hopkins Hospital - Appendix A & B

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins Hospital - Appendix A Only

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital - Appendix A Only

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • 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

    Site Not Available

  • Brigham and Women's Hospital - Appendix A Only

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Henry Ford Hospital - Appendix A & B

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital - Appendix A & B

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Mayo Clinic - Appendix A & B

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic - Appendix A & B

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • University of Mississippi Medical Center - Appendix A & B

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Mississippi Medical Center - Appendix A & B

    Jackson 4431410, Mississippi 4436296 39216
    United States

    Site Not Available

  • 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

    Site Not Available

  • Washington University School of Medicine - Appendix B Only

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • 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

    Site Not Available

  • University at Buffalo - Appendix A & B

    Buffalo, New York 14203
    United States

    Site Not Available

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

    Canton, New York 13617
    United States

    Site Not Available

  • Columbia University Irving Medical Center - Appendix A & B

    New York, New York 10032
    United States

    Site Not Available

  • Stony Brook University Hospital - Appendix A & B

    Stony Brook, New York 11794
    United States

    Site Not Available

  • University at Buffalo - Appendix A & B

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

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

    Canton 5111484, New York 5128638 13617
    United States

    Site Not Available

  • Columbia University Irving Medical Center - Appendix A & B

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Stony Brook University Hospital - Appendix A & B

    Stony Brook 5139865, New York 5128638 11794
    United States

    Site Not Available

  • Montefiore Medical Center - Moses Campus - Appendix B

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • Duke University Hospital - Appendix A & B

    Durham, North Carolina 27710
    United States

    Site Not Available

  • 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

    Site Not Available

  • Duke University Hospital - Appendix A & B

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • East Carolina University - Appendix B Only

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Site Not Available

  • Cleveland Clinic - Appendix A & B

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic - Appendix A & B

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

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

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

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

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Oregon Health and Science University - Appendix A & B

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University - Appendix A & B

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Kent Hospital - Appendix A & B

    Pawtucket, Rhode Island 02860
    United States

    Site Not Available

  • Kent Hospital - Appendix A & B

    Pawtucket 5223869, Rhode Island 5224323 02860
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • National Neuromuscular Research Institute - Appendix A & B

    Austin, Texas 78759
    United States

    Site Not Available

  • 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

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 78701
    United States

    Site Not Available

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

    San Antonio, Texas 78229
    United States

    Site Not Available

  • National Neuromuscular Research Institute - Appendix A & B

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Southwest Family Medicine Associates - Appendix A & B

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 78701
    United States

    Site Not Available

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

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Bateman Horne Center - Appendix B Only

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Bateman Horne Center - Appendix B Only

    Salt Lake City 5780993, Utah 5549030 84102
    United States

    Site Not Available

  • 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

    Site Not Available

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

    Burlington 5234372, Vermont 5242283 05405
    United States

    Site Not Available

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

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Sentara Norfolk General Hospital - Appendix A & B

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Sentara Norfolk General Hospital - Appendix A and B

    Norfolk, Virginia 23507
    United States

    Site Not Available

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

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Sentara Norfolk General Hospital - Appendix A & B

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

  • Evergreen Hospital Medical Center - Appendix A & B

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Providence Medical Research Center - Appendix A & B

    Spokane, Washington 99204
    United States

    Site Not Available

  • Evergreen Hospital Medical Center - Appendix A & B

    Kirkland 5799841, Washington 5815135 98034
    United States

    Site Not Available

  • Providence Medical Research Center - Appendix A & B

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

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

    Huntington, West Virginia 25701
    United States

    Site Not Available

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

    Huntington 4809537, West Virginia 4826850 25701
    United States

    Site Not Available

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