Protocollo della piattaforma RECOVER-ENERGIZE
RECOVER-ENERGIZE: un protocollo di piattaforma per la valutazione degli interventi per l'intolleranza all'esercizio fisico nelle sequele post-acute dell'infezione da SARS-CoV-2 (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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35205
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Banner University Medical Center Phoenix
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Tucson, Arizona, Stati Uniti, 85719
- Banner University Medical Center Tucson
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California
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Stanford, California, Stati Uniti, 94035
- Stanford University
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Torrance, California, Stati Uniti, 90509
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520-8017
- Yale - New Haven Hospital
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Florida
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Jacksonville, Florida, Stati Uniti, 32209
- University of Florida College of Medicine Jacksonville
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Miami, Florida, Stati Uniti, 33165
- Valencia Medical and Research Center
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Miami, Florida, Stati Uniti, 33144
- Innovation Clinical Trials Inc.
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Georgia
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Atlanta, Georgia, Stati Uniti, 30303
- Grady Memorial Hospital (Emory)
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Decatur, Georgia, Stati Uniti, 30030
- Emory Hope Clinic
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
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Chicago, Illinois, Stati Uniti, 60608
- University of Illinois at Chicago
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Evanston, Illinois, Stati Uniti, 60201
- North Shore University HealthSystem/Evanston Hospital
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Peoria, Illinois, Stati Uniti, 61637
- Saint Francis Medical Center
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Iowa
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Waterloo, Iowa, Stati Uniti, 50701
- Cedar Valley Clinical Research
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536
- University of Kentucky
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Maine
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Scarborough, Maine, Stati Uniti, 04074
- Maine Health Institute of Research
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Stati Uniti, 02111
- Tufts Medical Center
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Med. Ctr.
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Michigan
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- University of New Mexico Health Sciences Center
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New York
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Brooklyn, New York, Stati Uniti, 11220
- NYU Langone Health/Brooklyn Hospital
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- University of North Carolina Hospital
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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Oregon
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Portland, Oregon, Stati Uniti, 97239-3098
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57108
- Avera McKennan Hospital & University Health Center
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Texas
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Dallas, Texas, Stati Uniti, 75235
- Southwest Family Medicine Associates
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Houston, Texas, Stati Uniti, 77030
- Houston Methodist Hospital
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Houston, Texas, Stati Uniti, 77030
- University of Texas Health Science Center at Houston
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah
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Vermont
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Colchester, Vermont, Stati Uniti, 05446
- Vermont Lung Center, University of Vermont
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West Virginia
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Huntington, West Virginia, Stati Uniti, 25701
- University Physicians and Surgeons, Inc dba Marshall Health
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Morgantown, West Virginia, Stati Uniti, 26506
- West Virginia Clinical and Translational Science Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Number of Participants Enrolled in Each Appendix
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Gary M Felker, MD, Duke Clinical Research Institute
- Cattedra di studio: Barry Make, MD, National Jewish Health
- Cattedra di studio: Lucinda Bateman, MD, Bateman Horne Center
- Cattedra di studio: Janna Friedly, MD, MPH, University of Washington
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi post-infettivi
- COVID-19
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Infezioni delle vie respiratorie
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie delle vie respiratorie
- Malattie polmonari
- Polmonite, virale
- Polmonite
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Condizioni patologiche, segni e sintomi
- Comportamento
- Sindrome post-acuta da COVID-19
- Attività motoria
- Fattori socioeconomici
- Caratteristiche della popolazione
- Stato educativo
Altri numeri di identificazione dello studio
- Pro00112409
- OT2HL156812 (Sovvenzione/contratto NIH degli Stati Uniti)
- NHLBI Grant to RTI (Altro numero di sovvenzione/finanziamento: RTI subcontracting with DCRI)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The summary of the results will be shared on the study website: https://recovercovid.org/
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .