RECOVER-ENERGIZE-Plattformprotokoll
RECOVER-ENERGIZE: Ein Plattformprotokoll zur Bewertung von Interventionen bei Belastungsintoleranz bei postakuten Folgen einer SARS-CoV-2-Infektion (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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35205
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85006
- Banner University Medical Center Phoenix
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Tucson, Arizona, Vereinigte Staaten, 85719
- Banner University Medical Center Tucson
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California
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Stanford, California, Vereinigte Staaten, 94035
- Stanford University
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Torrance, California, Vereinigte Staaten, 90509
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06520-8017
- Yale - New Haven Hospital
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32209
- University of Florida College of Medicine Jacksonville
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Miami, Florida, Vereinigte Staaten, 33165
- Valencia Medical and Research Center
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Miami, Florida, Vereinigte Staaten, 33144
- Innovation Clinical Trials Inc.
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30303
- Grady Memorial Hospital (Emory)
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Decatur, Georgia, Vereinigte Staaten, 30030
- Emory Hope Clinic
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Rush University Medical Center
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Chicago, Illinois, Vereinigte Staaten, 60608
- University of Illinois at Chicago
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Evanston, Illinois, Vereinigte Staaten, 60201
- North Shore University HealthSystem/Evanston Hospital
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Peoria, Illinois, Vereinigte Staaten, 61637
- Saint Francis Medical Center
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Iowa
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Waterloo, Iowa, Vereinigte Staaten, 50701
- Cedar Valley Clinical Research
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40536
- University of Kentucky
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Maine
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Scarborough, Maine, Vereinigte Staaten, 04074
- Maine Health Institute of Research
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02111
- Tufts Medical Center
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Med. Ctr.
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87102
- University of New Mexico Health Sciences Center
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New York
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Brooklyn, New York, Vereinigte Staaten, 11220
- NYU Langone Health/Brooklyn Hospital
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27514
- University of North Carolina Hospital
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University Medical Center
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239-3098
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University of Pittsburgh
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South Dakota
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Sioux Falls, South Dakota, Vereinigte Staaten, 57108
- Avera McKennan Hospital & University Health Center
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Texas
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Dallas, Texas, Vereinigte Staaten, 75235
- Southwest Family Medicine Associates
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Houston, Texas, Vereinigte Staaten, 77030
- Houston Methodist Hospital
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Houston, Texas, Vereinigte Staaten, 77030
- University of Texas Health Science Center at Houston
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84132
- University of Utah
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Vermont
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Colchester, Vermont, Vereinigte Staaten, 05446
- Vermont Lung Center, University of Vermont
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West Virginia
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Huntington, West Virginia, Vereinigte Staaten, 25701
- University Physicians and Surgeons, Inc dba Marshall Health
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Morgantown, West Virginia, Vereinigte Staaten, 26506
- West Virginia Clinical and Translational Science Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total Number of Participants Enrolled in Each Appendix
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Gary M Felker, MD, Duke Clinical Research Institute
- Studienstuhl: Barry Make, MD, National Jewish Health
- Studienstuhl: Lucinda Bateman, MD, Bateman Horne Center
- Studienstuhl: Janna Friedly, MD, MPH, University of Washington
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Postinfektiöse Erkrankungen
- COVID-19
- Pathologische Prozesse
- Chronische Erkrankung
- Krankheitsattribute
- Infektionen der Atemwege
- Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Pneumonie, viral
- Lungenentzündung
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Postakutes COVID-19-Syndrom
- Motorik
- Sozioökonomische Faktoren
- Bevölkerungseigenschaften
- Bildungsstatus
Andere Studien-ID-Nummern
- Pro00112409
- OT2HL156812 (US NIH Stipendium/Vertrag)
- NHLBI Grant to RTI (Andere Zuschuss-/Finanzierungsnummer: RTI subcontracting with DCRI)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The summary of the results will be shared on the study website: https://recovercovid.org/
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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