RECOVER-ENERGIZE Platform Protocol
Purpose
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.
Conditions
- Long COVID
- Long Covid19
- Long Covid-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This platform protocol is designed to allocate participants into an appropriate intervention appendix based on their symptoms of exercise intolerance or post-exertional malaise (PEM). Once assigned to an appendix, eligible participants are randomized in a 1:1 ratio to either the study intervention group or a control group.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Appendix A: Single (Outcomes Assessor masked) The assessor of the primary outcome, Endurance Shuttle Walk Test (ESWT), is blinded. Appendix B: None (open label / no masking)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35205
Birmingham 4049979, Alabama 4829764 35205
Banner University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Banner University Medical Center Tucson
Tucson 5318313, Arizona 5551752 85719
Tucson 5318313, Arizona 5551752 85719
Stanford University
Stanford 5398563, California 5332921 94035
Stanford 5398563, California 5332921 94035
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance 5403022, California 5332921 90509
Torrance 5403022, California 5332921 90509
University of Colorado
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Yale - New Haven Hospital
New Haven 4839366, Connecticut 4831725 06520-8017
New Haven 4839366, Connecticut 4831725 06520-8017
University of Florida College of Medicine Jacksonville
Jacksonville 4160021, Florida 4155751 32209
Jacksonville 4160021, Florida 4155751 32209
Innovation Clinical Trials Inc.
Miami 4164138, Florida 4155751 33144
Miami 4164138, Florida 4155751 33144
Valencia Medical and Research Center
Miami 4164138, Florida 4155751 33165
Miami 4164138, Florida 4155751 33165
Grady Memorial Hospital (Emory)
Atlanta 4180439, Georgia 4197000 30303
Atlanta 4180439, Georgia 4197000 30303
Emory Hope Clinic
Decatur 4191124, Georgia 4197000 30030
Decatur 4191124, Georgia 4197000 30030
University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60608
Chicago 4887398, Illinois 4896861 60608
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
North Shore University HealthSystem/Evanston Hospital
Evanston 4891382, Illinois 4896861 60201
Evanston 4891382, Illinois 4896861 60201
Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
Peoria 4905687, Illinois 4896861 61637
Cedar Valley Clinical Research
Waterloo 4880889, Iowa 4862182 50701
Waterloo 4880889, Iowa 4862182 50701
Kansas University Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
University of Kentucky
Lexington 4297983, Kentucky 6254925 40536
Lexington 4297983, Kentucky 6254925 40536
Maine Health Institute of Research
Scarborough 4977882, Maine 4971068 04074
Scarborough 4977882, Maine 4971068 04074
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Boston 4930956, Massachusetts 6254926 02111
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
Beth Israel Deaconess Med. Ctr.
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48202
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
Lebanon 5088597, New Hampshire 5090174 03756
University of New Mexico Health Sciences Center
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87102
NYU Langone Health/Brooklyn Hospital
Brooklyn 5110302, New York 5128638 11220
Brooklyn 5110302, New York 5128638 11220
University of North Carolina Hospital
Chapel Hill 4460162, North Carolina 4482348 27514
Chapel Hill 4460162, North Carolina 4482348 27514
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239-3098
Portland 5746545, Oregon 5744337 97239-3098
University of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Avera McKennan Hospital & University Health Center
Sioux Falls 5231851, South Dakota 5769223 57108
Sioux Falls 5231851, South Dakota 5769223 57108
Southwest Family Medicine Associates
Dallas 4684888, Texas 4736286 75235
Dallas 4684888, Texas 4736286 75235
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Utah
Salt Lake City 5780993, Utah 5549030 84132
Salt Lake City 5780993, Utah 5549030 84132
Vermont Lung Center, University of Vermont
Colchester 5235024, Vermont 5242283 05446
Colchester 5235024, Vermont 5242283 05446
University Physicians and Surgeons, Inc dba Marshall Health
Huntington 4809537, West Virginia 4826850 25701
Huntington 4809537, West Virginia 4826850 25701
West Virginia Clinical and Translational Science Institute
Morgantown 4815352, West Virginia 4826850 26506
Morgantown 4815352, West Virginia 4826850 26506
More Details
- NCT ID
- NCT06404047
- Status
- Recruiting
- Sponsor
- Duke University
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.