RECOVER-ENERGIZE-platformprotocol
RECOVER-ENERGIZE: een platformprotocol voor de evaluatie van interventies voor inspanningsintolerantie bij postacute gevolgen van SARS-CoV-2-infectie (PASC)
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35205
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006
- Banner University Medical Center Phoenix
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Tucson, Arizona, Verenigde Staten, 85719
- Banner University Medical Center Tucson
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California
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Stanford, California, Verenigde Staten, 94035
- Stanford University
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Torrance, California, Verenigde Staten, 90509
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06520-8017
- Yale - New Haven Hospital
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Florida
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Jacksonville, Florida, Verenigde Staten, 32209
- University of Florida College of Medicine Jacksonville
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Miami, Florida, Verenigde Staten, 33165
- Valencia Medical and Research Center
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Miami, Florida, Verenigde Staten, 33144
- Innovation Clinical Trials Inc.
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Grady Memorial Hospital (Emory)
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Decatur, Georgia, Verenigde Staten, 30030
- Emory Hope Clinic
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Rush University Medical Center
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Chicago, Illinois, Verenigde Staten, 60608
- University of Illinois at Chicago
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Evanston, Illinois, Verenigde Staten, 60201
- North Shore University HealthSystem/Evanston Hospital
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Peoria, Illinois, Verenigde Staten, 61637
- Saint Francis Medical Center
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Iowa
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Waterloo, Iowa, Verenigde Staten, 50701
- Cedar Valley Clinical Research
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536
- University of Kentucky
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Maine
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Scarborough, Maine, Verenigde Staten, 04074
- Maine Health Institute of Research
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Verenigde Staten, 02111
- Tufts Medical Center
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Med. Ctr.
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
- University of New Mexico Health Sciences Center
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New York
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Brooklyn, New York, Verenigde Staten, 11220
- NYU Langone Health/Brooklyn Hospital
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27514
- University of North Carolina Hospital
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Durham, North Carolina, Verenigde Staten, 27710
- Duke University Medical Center
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Oregon
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Portland, Oregon, Verenigde Staten, 97239-3098
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburgh
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South Dakota
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Sioux Falls, South Dakota, Verenigde Staten, 57108
- Avera McKennan Hospital & University Health Center
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Texas
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Dallas, Texas, Verenigde Staten, 75235
- Southwest Family Medicine Associates
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Houston, Texas, Verenigde Staten, 77030
- Houston Methodist Hospital
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Houston, Texas, Verenigde Staten, 77030
- University of Texas Health Science Center at Houston
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- University of Utah
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Vermont
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Colchester, Vermont, Verenigde Staten, 05446
- Vermont Lung Center, University of Vermont
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West Virginia
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Huntington, West Virginia, Verenigde Staten, 25701
- University Physicians and Surgeons, Inc dba Marshall Health
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Morgantown, West Virginia, Verenigde Staten, 26506
- West Virginia Clinical and Translational Science Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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≥ 18 years of age at the time of enrollment
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Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization*
- Suspected* or probable SARS-CoV-2 infection will only be allowed if it occurred before May 1, 2021, and will be limited to no more than 10% of the study population. 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 THREE OR 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 a COVID-19 cluster; or B. Acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization; or C. With no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-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 or confirmed 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 clinical criteria OR epidemiological criteria; or B. Meeting clinical criteria AND/OR epidemiological criteria (See suspected case A above for criteria). With a positive professional use or self-test SARS- CoV-2 Antigen-Rapid Diagnostic Test.
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Self-reported limitation to physical activity due to the presence of symptoms such as fatigue, shortness of breath, and/or PEM following a SARS-CoV-2 infection, that has persisted for at least 12 weeks and is present at the time of consent.
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Willing, able, and agree to provide informed consent, complete questionnaires and outcome assessments, and participate in the study, including assigned intervention or control and study visits whether remote, hybrid, or in-person.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent.
- Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), not related to SARS-CoV-2 infection.
- Current or recent use (within the last 14 days) of a formal program utilizing one or more of the current study intervention(s) or similar intervention(s) to treat the underlying condition, unless a washout period is permitted per Appendices.
- Participation in another interventional clinical trial.
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Experimental: Appendix A - Cardiopulmonary Rehabilitation (Exercise Intolerance)
Appendix A is a randomized controlled trial designed to evaluate the effect of a 12-week personalized cardiopulmonary rehabilitation intervention on exercise tolerance in participants with PASC. Participants who meet eligibility criteria for Appendix A will be assigned to either Personalized Cardiopulmonary Rehabilitation (study intervention group) or Education (control group) in a 1:1 ratio. The intervention duration is 12 weeks with a follow-up period of 3 months (total study duration of 6 months). Anticipated enrollment is 360 participants. Details about Appendix A: Cardiopulmonary Rehabilitation (Exercise Intolerance) are available under NCT06404060. |
Participants in this group will complete 2-3 cardiopulmonary rehabilitation sessions per week, for 12 weeks, as tolerated. Rehabilitation sessions are provided by respiratory therapists, exercise physiologists, physical therapists, nurses, or others who have experience and training in either pulmonary or cardiac rehabilitation. Rehabilitation sessions (adjusted based on the participant's baseline assessment, symptoms, and progress) last about 1 hour and include education, aerobic exercise, strength, and flexibility training. Participants in this group will receive two general education sessions at the start of the intervention with weekly phone/virtual follow-ups from site study staff. |
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Experimenteel: Experimental: Appendix B - Structured Pacing (PEM)
Appendix B is a randomized controlled trial designed to evaluate the effect of a 12-week Structured Pacing intervention on reducing the symptoms of post-exertional malaise (PEM) in participants with PASC. Participants who meet eligibility criteria for Appendix B will be assigned to either Structured Pacing (study intervention group) or Usual Care (control group) in a 1:1 ratio. The intervention duration is 12 weeks with a follow-up period of 3 months (total study duration of 6 months). Anticipated enrollment is 300 participants. Details about Appendix B: Structured Pacing (PEM) are available under NCT06404073. |
Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications. Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Total Number of Participants Enrolled in Each Appendix
Tijdsspanne: 6 months
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Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID. |
6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Gary M Felker, MD, Duke Clinical Research Institute
- Studie stoel: Barry Make, MD, National Jewish Health
- Studie stoel: Lucinda Bateman, MD, Bateman Horne Center
- Studie stoel: Janna Friedly, MD, MPH, University of Washington
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Post-infectieuze aandoeningen
- COVID-19
- Pathologische processen
- Chronische ziekte
- Ziekte attributen
- Luchtweginfecties
- Infecties
- RNA-virusinfecties
- Virusziekten
- Ziekten van de luchtwegen
- Longziekten
- Longontsteking, viraal
- Longontsteking
- Coronavirus-infecties
- Coronaviridae-infecties
- Nidovirales-infecties
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Postacuut COVID-19-syndroom
- Motorische activiteit
- Sociaaleconomische factoren
- Bevolkingskenmerken
- Educatieve status
Andere studie-ID-nummers
- Pro00112409
- OT2HL156812 (Subsidie/contract van de Amerikaanse NIH)
- NHLBI Grant to RTI (Ander subsidie-/financieringsnummer: RTI subcontracting with DCRI)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
The summary of the results will be shared on the study website: https://recovercovid.org/
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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