Protocolo de plataforma RECOVER-ENERGIZE
RECOVER-ENERGIZE: Protocolo de plataforma para la evaluación de intervenciones para la intolerancia al ejercicio en las secuelas posagudas de la infección por 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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Banner University Medical Center Phoenix
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Tucson, Arizona, Estados Unidos, 85719
- Banner University Medical Center Tucson
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California
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Stanford, California, Estados Unidos, 94035
- Stanford University
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Torrance, California, Estados Unidos, 90509
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8017
- Yale - New Haven Hospital
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Florida
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Jacksonville, Florida, Estados Unidos, 32209
- University of Florida College of Medicine Jacksonville
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Miami, Florida, Estados Unidos, 33165
- Valencia Medical and Research Center
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Miami, Florida, Estados Unidos, 33144
- Innovation Clinical Trials Inc.
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Georgia
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Atlanta, Georgia, Estados Unidos, 30303
- Grady Memorial Hospital (Emory)
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Decatur, Georgia, Estados Unidos, 30030
- Emory Hope Clinic
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60608
- University of Illinois at Chicago
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Evanston, Illinois, Estados Unidos, 60201
- North Shore University HealthSystem/Evanston Hospital
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Peoria, Illinois, Estados Unidos, 61637
- Saint Francis Medical Center
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Iowa
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Waterloo, Iowa, Estados Unidos, 50701
- Cedar Valley Clinical Research
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Maine
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Scarborough, Maine, Estados Unidos, 04074
- Maine Health Institute of Research
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Med. Ctr.
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- University of New Mexico Health Sciences Center
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New York
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Brooklyn, New York, Estados Unidos, 11220
- NYU Langone Health/Brooklyn Hospital
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina Hospital
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Oregon
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Portland, Oregon, Estados Unidos, 97239-3098
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57108
- Avera McKennan Hospital & University Health Center
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Southwest Family Medicine Associates
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Hospital
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Houston, Texas, Estados Unidos, 77030
- University of Texas Health Science Center at Houston
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah
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Vermont
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Colchester, Vermont, Estados Unidos, 05446
- Vermont Lung Center, University of Vermont
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- University Physicians and Surgeons, Inc dba Marshall Health
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Morgantown, West Virginia, Estados Unidos, 26506
- West Virginia Clinical and Translational Science Institute
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Number of Participants Enrolled in Each Appendix
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Silla de estudio: Gary M Felker, MD, Duke Clinical Research Institute
- Silla de estudio: Barry Make, MD, National Jewish Health
- Silla de estudio: Lucinda Bateman, MD, Bateman Horne Center
- Silla de estudio: Janna Friedly, MD, MPH, University of Washington
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos posinfecciosos
- COVID-19
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Infecciones del Tracto Respiratorio
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neumonía Viral
- Neumonía
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Síndrome post-agudo de COVID-19
- Actividad del motor
- Factores socioeconómicos
- Características de la población
- Estado educativo
Otros números de identificación del estudio
Otros números de identificación del estudio
- Pro00112409
- OT2HL156812 (Subvención/contrato del NIH de EE. UU.)
- NHLBI Grant to RTI (Otro número de subvención/financiamiento: RTI subcontracting with DCRI)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The summary of the results will be shared on the study website: https://recovercovid.org/
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .