Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
660 participants
INTERVENTIONAL
2024-07-17
2025-10-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Appendix B: None (open label / no masking)
Study Groups
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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.
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.
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.
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.
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.
Usual Care
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.
Interventions
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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.
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.
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.
Usual Care
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Gary M Felker, MD
Role: STUDY_CHAIR
Duke Clinical Research Institute
Barry Make, MD
Role: STUDY_CHAIR
National Jewish Health
Lucinda Bateman, MD
Role: STUDY_CHAIR
Bateman Horne Center
Janna Friedly, MD, MPH
Role: STUDY_CHAIR
University of Washington
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Banner University Medical Center Tucson
Tucson, Arizona, 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
Yale - New Haven Hospital
New Haven, Connecticut, United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States
Innovation Clinical Trials Inc.
Miami, Florida, United States
Valencia Medical and Research Center
Miami, Florida, United States
Grady Memorial Hospital (Emory)
Atlanta, Georgia, United States
Emory Hope Clinic
Decatur, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
North Shore University HealthSystem/Evanston Hospital
Evanston, Illinois, 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
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
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 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
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Related Info
Other Identifiers
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NHLBI Grant to RTI
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00112409
Identifier Type: -
Identifier Source: org_study_id