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RECOVER-ENERGIZE 平台协议

2026年10月14日 更新者：Duke University

RECOVER-ENERGIZE：评估 SARS-CoV-2 感染急性后遗症运动不耐受干预措施的平台方案 (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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

660

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix、Arizona、美国、85006
        • Banner University Medical Center Phoenix
      • Tucson、Arizona、美国、85719
        • Banner University Medical Center Tucson
    • California
      • Stanford、California、美国、94035
        • Stanford University
      • Torrance、California、美国、90509
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado
    • Connecticut
      • New Haven、Connecticut、美国、06520-8017
        • Yale - New Haven Hospital
    • Florida
      • Jacksonville、Florida、美国、32209
        • University of Florida College of Medicine Jacksonville
      • Miami、Florida、美国、33165
        • Valencia Medical and Research Center
      • Miami、Florida、美国、33144
        • Innovation Clinical Trials Inc.
    • Georgia
      • Atlanta、Georgia、美国、30303
        • Grady Memorial Hospital (Emory)
      • Decatur、Georgia、美国、30030
        • Emory Hope Clinic
    • Illinois
      • Chicago、Illinois、美国、60612
        • Rush University Medical Center
      • Chicago、Illinois、美国、60608
        • University of Illinois at Chicago
      • Evanston、Illinois、美国、60201
        • North Shore University HealthSystem/Evanston Hospital
      • Peoria、Illinois、美国、61637
        • Saint Francis Medical Center
    • Iowa
      • Waterloo、Iowa、美国、50701
        • Cedar Valley Clinical Research
    • Kansas
      • Kansas City、Kansas、美国、66160
        • Kansas University Medical Center
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky
    • Maine
      • Scarborough、Maine、美国、04074
        • Maine Health Institute of Research
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02111
        • Tufts Medical Center
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Med. Ctr.
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Missouri
      • St Louis、Missouri、美国、63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth Hitchcock Medical Center
    • New Mexico
      • Albuquerque、New Mexico、美国、87102
        • University of New Mexico Health Sciences Center
    • New York
      • Brooklyn、New York、美国、11220
        • NYU Langone Health/Brooklyn Hospital
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • University of North Carolina Hospital
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
    • Oregon
      • Portland、Oregon、美国、97239-3098
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh
    • South Dakota
      • Sioux Falls、South Dakota、美国、57108
        • Avera McKennan Hospital & University Health Center
    • Texas
      • Dallas、Texas、美国、75235
        • Southwest Family Medicine Associates
      • Houston、Texas、美国、77030
        • Houston Methodist Hospital
      • Houston、Texas、美国、77030
        • University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City、Utah、美国、84132
        • University of Utah
    • Vermont
      • Colchester、Vermont、美国、05446
        • Vermont Lung Center, University of Vermont
    • West Virginia
      • Huntington、West Virginia、美国、25701
        • University Physicians and Surgeons, Inc dba Marshall Health
      • Morgantown、West Virginia、美国、26506
        • West Virginia Clinical and Translational Science Institute

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. ≥ 18 years of age at the time of enrollment

  2. 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.

  3. 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.

  4. 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:

  1. Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent.
  2. Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), not related to SARS-CoV-2 infection.
  3. 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.
  4. Participation in another interventional clinical trial.
  5. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：Personalized Cardiopulmonary Rehabilitation

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.

其他：Education

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.
实验性的：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.
行为的：Structured Pacing

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.

其他：Usual Care

Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Total Number of Participants Enrolled in Each Appendix
大体时间：6 months

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Duke University

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

  • 学习椅：Gary M Felker, MD、Duke Clinical Research Institute
  • 学习椅：Barry Make, MD、National Jewish Health
  • 学习椅：Lucinda Bateman, MD、Bateman Horne Center
  • 学习椅：Janna Friedly, MD, MPH、University of Washington

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月17日

初级完成 (实际的)

2025年10月30日

研究完成 (实际的)

2025年10月30日

研究注册日期

首次提交

2024年5月3日

首先提交符合 QC 标准的

2024年5月6日

首次发布 (实际的)

2024年5月8日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月14日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Pro00112409
  • OT2HL156812 (美国 NIH 拨款/合同)
  • NHLBI Grant to RTI (其他赠款/资助编号：RTI subcontracting with DCRI)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The summary of the results will be shared on the study website: https://recovercovid.org/

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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