RECOVER-ENERGIZE Platform Protocol

Last updated: November 13, 2025
Sponsor: Duke University
Overall Status: Completed

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:
October 30, 2025

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

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35205
    United States

    Site Not Available

  • Banner University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Banner University Medical Center Tucson

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Banner University Medical Center Phoenix

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Site Not Available

  • Banner University Medical Center Tucson

    Tucson 5318313, Arizona 5551752 85719
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94035
    United States

    Site Not Available

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

    Torrance, California 90509
    United States

    Site Not Available

  • Stanford University

    Stanford 5398563, California 5332921 94035
    United States

    Site Not Available

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

    Torrance 5403022, California 5332921 90509
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Yale - New Haven Hospital

    New Haven, Connecticut 06520-8017
    United States

    Site Not Available

  • Yale - New Haven Hospital

    New Haven 4839366, Connecticut 4831725 06520-8017
    United States

    Site Not Available

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Innovation Clinical Trials Inc.

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Valencia Medical and Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • University of Florida College of Medicine Jacksonville

    Jacksonville 4160021, Florida 4155751 32209
    United States

    Site Not Available

  • Innovation Clinical Trials Inc.

    Miami 4164138, Florida 4155751 33144
    United States

    Site Not Available

  • Valencia Medical and Research Center

    Miami 4164138, Florida 4155751 33165
    United States

    Site Not Available

  • Grady Memorial Hospital (Emory)

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Emory Hope Clinic

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Grady Memorial Hospital (Emory)

    Atlanta 4180439, Georgia 4197000 30303
    United States

    Site Not Available

  • Emory Hope Clinic

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • 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

    Site Not Available

  • Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago 4887398, Illinois 4896861 60608
    United States

    Site Not Available

  • North Shore University HealthSystem/Evanston Hospital

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • Saint Francis Medical Center

    Peoria 4905687, Illinois 4896861 61637
    United States

    Site Not Available

  • Cedar Valley Clinical Research

    Waterloo, Iowa 50701
    United States

    Site Not Available

  • Cedar Valley Clinical Research

    Waterloo 4880889, Iowa 4862182 50701
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • Maine Health Institute of Research

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Maine Health Institute of Research

    Scarborough 4977882, Maine 4971068 04074
    United States

    Site Not Available

  • 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

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Beth Israel Deaconess Med. Ctr.

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • University of New Mexico Health Sciences Center

    Albuquerque 5454711, New Mexico 5481136 87102
    United States

    Site Not Available

  • 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

  • NYU Langone Health/Brooklyn Hospital

    Brooklyn 5110302, New York 5128638 11220
    United States

    Site Not Available

  • University of North Carolina Hospital

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of North Carolina Hospital

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239-3098
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239-3098
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Avera McKennan Hospital & University Health Center

    Sioux Falls 5231851, South Dakota 5769223 57108
    United States

    Site Not Available

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Southwest Family Medicine Associates

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Site Not Available

  • Vermont Lung Center, University of Vermont

    Colchester, Vermont 05446
    United States

    Site Not Available

  • Vermont Lung Center, University of Vermont

    Colchester 5235024, Vermont 5242283 05446
    United States

    Site Not Available

  • 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

    Site Not Available

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University Physicians and Surgeons, Inc dba Marshall Health

    Huntington 4809537, West Virginia 4826850 25701
    United States

    Site Not Available

  • West Virginia Clinical and Translational Science Institute

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

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