Protocolo da plataforma RECOVER-ENERGIZE
RECOVER-ENERGIZE: Um protocolo de plataforma para avaliação de intervenções para intolerância ao exercício em sequelas pós-agudas de infecção 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total Number of Participants Enrolled in Each Appendix
Prazo: 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
Colaboradores
Investigadores
- Cadeira de estudo: Gary M Felker, MD, Duke Clinical Research Institute
- Cadeira de estudo: Barry Make, MD, National Jewish Health
- Cadeira de estudo: Lucinda Bateman, MD, Bateman Horne Center
- Cadeira de estudo: Janna Friedly, MD, MPH, University of Washington
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios pós-infecciosos
- COVID-19
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Infecções do Trato Respiratório
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Doenças Respiratórias
- Doenças pulmonares
- Pneumonia Viral
- Pneumonia
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Síndrome Pós-Aguda de COVID-19
- Atividade motora
- Fatores socioeconômicos
- Características da população
- Status educacional
Outros números de identificação do estudo
- Pro00112409
- OT2HL156812 (Concessão/Contrato do NIH dos EUA)
- NHLBI Grant to RTI (Número de outro subsídio/financiamento: RTI subcontracting with DCRI)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The summary of the results will be shared on the study website: https://recovercovid.org/
Informações sobre medicamentos e dispositivos, documentos de estudo
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