RECOVER-ENERGIZE Platform Protocol
- Conditions
- Long Covid-19Long Covid19Long COVID
- Interventions
- Behavioral: Personalized Cardiopulmonary RehabilitationBehavioral: Structured PacingOther: Usual CareOther: Education
- Registration Number
- NCT06404047
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 660
-
≥ 18 years of age at the time of enrollment
-
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.
-
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.
-
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Appendix B - Structured Pacing (PEM) Usual Care 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. Experimental: Appendix A - Cardiopulmonary Rehabilitation (Exercise Intolerance) Personalized Cardiopulmonary Rehabilitation 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. Experimental: Appendix A - Cardiopulmonary Rehabilitation (Exercise Intolerance) Education 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. Experimental: Appendix B - Structured Pacing (PEM) Structured Pacing 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.
- Primary Outcome Measures
Name Time Method Total number of participants enrolled in each Appendix 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#
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Banner University Medical Center Tucson
🇺🇸Tucson, Arizona, United States
Yale - New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Innovation Clinical Trials Inc.
🇺🇸Miami, Florida, United States
Valencia Medical and Research Center
🇺🇸Miami, Florida, United States
Stanford University
🇺🇸Stanford, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Emory Hope Clinic
🇺🇸Decatur, Georgia, United States
Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Cedar Valley Clinical Research
🇺🇸Waterloo, Iowa, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Maine Health Institute of Research
🇺🇸Scarborough, Maine, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Florida College of Medicine Jacksonville
🇺🇸Jacksonville, Florida, United States
Grady Memorial Hospital (Emory)
🇺🇸Atlanta, Georgia, United States
North Shore University HealthSystem/Evanston Hospital
🇺🇸Evanston, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr.
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
NYU Langone Health/Brooklyn Hospital
🇺🇸Brooklyn, New York, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Avera McKennan Hospital & University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Vermont Lung Center, University of Vermont
🇺🇸Colchester, Vermont, United States
University Physicians and Surgeons, Inc dba Marshall Health
🇺🇸Huntington, West Virginia, United States
West Virginia Clinical and Translational Science Institute
🇺🇸Morgantown, West Virginia, United States