RECOVER-ENERGIZE Platform Protocol
RECOVER-ENERGIZE: En platformsprotokol til evaluering af interventioner for træningsintolerance i postakutte følgesygdomme af 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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
- Banner University Medical Center Phoenix
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Tucson, Arizona, Forenede Stater, 85719
- Banner University Medical Center Tucson
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California
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Stanford, California, Forenede Stater, 94035
- Stanford University
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Torrance, California, Forenede Stater, 90509
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520-8017
- Yale - New Haven Hospital
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Florida
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Jacksonville, Florida, Forenede Stater, 32209
- University of Florida College of Medicine Jacksonville
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Miami, Florida, Forenede Stater, 33165
- Valencia Medical and Research Center
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Miami, Florida, Forenede Stater, 33144
- Innovation Clinical Trials Inc.
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Grady Memorial Hospital (Emory)
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Decatur, Georgia, Forenede Stater, 30030
- Emory Hope Clinic
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60608
- University of Illinois at Chicago
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Evanston, Illinois, Forenede Stater, 60201
- North Shore University HealthSystem/Evanston Hospital
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Peoria, Illinois, Forenede Stater, 61637
- Saint Francis Medical Center
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Iowa
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Waterloo, Iowa, Forenede Stater, 50701
- Cedar Valley Clinical Research
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky
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Maine
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Scarborough, Maine, Forenede Stater, 04074
- Maine Health Institute of Research
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Med. Ctr.
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- University of New Mexico Health Sciences Center
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New York
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Brooklyn, New York, Forenede Stater, 11220
- NYU Langone Health/Brooklyn Hospital
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- University of North Carolina Hospital
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Oregon
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Portland, Oregon, Forenede Stater, 97239-3098
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57108
- Avera McKennan Hospital & University Health Center
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Texas
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Dallas, Texas, Forenede Stater, 75235
- Southwest Family Medicine Associates
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
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Houston, Texas, Forenede Stater, 77030
- University of Texas Health Science Center at Houston
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah
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Vermont
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Colchester, Vermont, Forenede Stater, 05446
- Vermont Lung Center, University of Vermont
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- University Physicians and Surgeons, Inc dba Marshall Health
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Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia Clinical and Translational Science Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Number of Participants Enrolled in Each Appendix
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Gary M Felker, MD, Duke Clinical Research Institute
- Studiestol: Barry Make, MD, National Jewish Health
- Studiestol: Lucinda Bateman, MD, Bateman Horne Center
- Studiestol: Janna Friedly, MD, MPH, University of Washington
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Post-infektionssygdomme
- COVID-19
- Patologiske processer
- Kronisk sygdom
- Sygdomsegenskaber
- Luftvejsinfektioner
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Luftvejssygdomme
- Lungesygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Post-akut COVID-19 syndrom
- Motorisk aktivitet
- Socioøkonomiske faktorer
- Befolkningsegenskaber
- Uddannelsesstatus
Andre undersøgelses-id-numre
- Pro00112409
- OT2HL156812 (U.S. NIH-bevilling/kontrakt)
- NHLBI Grant to RTI (Andet bevillings-/finansieringsnummer: RTI subcontracting with DCRI)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The summary of the results will be shared on the study website: https://recovercovid.org/
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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