RECOVER-ENERGIZE Platform Protocol

Last updated: May 19, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

Usual Care

Education

Personalized Cardiopulmonary Rehabilitation

Clinical Study ID

NCT06404047
Pro00112409
NHLBI Grant to RTI
OT2HL156812
  • Ages > 18
  • All Genders

Study Summary

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).

The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

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 Organization*

  • Suspected* or probable SARS-CoV-2 infection will only be allowed if it occurredbefore May 1, 2021, and will be limited to no more than 10% of the studypopulation. Otherwise, confirmed cases are required. Suspected case of SARS-CoV-2 infection - Three options, A through C: A. A person who meets the clinical OR epidemiological criteria. Clinical criteria:Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREEOR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue,headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia.Epidemiological criteria: Contact of a probable or confirmed case or linked to aCOVID-19 cluster; or B. Acute respiratory infection with history of fever ormeasured fever of ≥ 38°C; and cough; with onset within the last 10 days; and whorequires hospitalization; or C. With no clinical signs or symptoms, NOR meetingepidemiologic criteria with a positive professional use or self-test SARS-CoV-2Antigen-Rapid Diagnostic Test. Probable case of SARS-CoV-2 infection: A. A patient who meets clinical criteria above AND is a contact of a probable orconfirmed case or is linked to a COVID-19 cluster. Confirmed case of SARS-CoV-2 infection - Two options, A and 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 suspected case A above for criteria). With a positiveprofessional use or self-test SARS- CoV-2 Antigen-Rapid Diagnostic Test.
  1. Self-reported limitation to physical activity due to the presence of symptoms suchas fatigue, shortness of breath, and/or PEM following a SARS-CoV-2 infection, thathas persisted for at least 12 weeks and is present at the time of consent.

  2. Willing, able, and agree to provide informed consent, complete questionnaires andoutcome assessments, and participate in the study, including assigned interventionor control and study visits whether remote, hybrid, or in-person.

Exclusion

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent.

  2. Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), not related to SARS-CoV-2 infection.

  3. Current or recent use (within the last 14 days) of a formal program utilizing one ormore of the current study intervention(s) or similar intervention(s) to treat theunderlying condition, unless a washout period is permitted per Appendices.

  4. Participation in another interventional clinical trial.

  5. Any condition that would make the participant, in the opinion of the investigator,unsuitable for the study.

Study Design

Total Participants: 660
Treatment Group(s): 4
Primary Treatment: Usual Care
Phase:
Study Start date:
July 17, 2024
Estimated Completion Date:
January 31, 2026

Study Description

Study 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. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence.

The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Banner University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Banner University Medical Center Tucson

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94035
    United States

    Active - Recruiting

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California 90509
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale - New Haven Hospital

    New Haven, Connecticut 06520-8017
    United States

    Active - Recruiting

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Innovation Clinical Trials Inc.

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Valencia Medical and Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Grady Memorial Hospital (Emory)

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Emory Hope Clinic

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60608
    United States

    Active - Recruiting

  • North Shore University HealthSystem/Evanston Hospital

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • Cedar Valley Clinical Research

    Waterloo, Iowa 50701
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Maine Health Institute of Research

    Scarborough, Maine 04074
    United States

    Active - Recruiting

  • Jadestone Clinical Research, LLC

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Beth Israel Deaconess Med. Ctr.

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • NYU Langone Health/Brooklyn Hospital

    Brooklyn, New York 11220
    United States

    Site Not Available

  • NYU Langone

    New York, New York 10017
    United States

    Site Not Available

  • University of North Carolina Hospital

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239-3098
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Vermont Lung Center, University of Vermont

    Colchester, Vermont 05446
    United States

    Active - Recruiting

  • Evergreen Hospital Medical Center

    Kirkland, Washington 98034
    United States

    Site Not Available

  • University Physicians and Surgeons, Inc dba Marshall Health

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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