RECOVER-ENERGIZE Platform Protocol
RECOVER-ENERGIZE: Ett plattformsprotokoll för utvärdering av interventioner för träningsintolerans vid postakuta följdsjukdomar av SARS-CoV-2-infektion (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35205
- University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85006
- Banner University Medical Center Phoenix
-
Tucson, Arizona, Förenta staterna, 85719
- Banner University Medical Center Tucson
-
-
California
-
Stanford, California, Förenta staterna, 94035
- Stanford University
-
Torrance, California, Förenta staterna, 90509
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- University of Colorado
-
-
Connecticut
-
New Haven, Connecticut, Förenta staterna, 06520-8017
- Yale - New Haven Hospital
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32209
- University of Florida College of Medicine Jacksonville
-
Miami, Florida, Förenta staterna, 33165
- Valencia Medical and Research Center
-
Miami, Florida, Förenta staterna, 33144
- Innovation Clinical Trials Inc.
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30303
- Grady Memorial Hospital (Emory)
-
Decatur, Georgia, Förenta staterna, 30030
- Emory Hope Clinic
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
-
Chicago, Illinois, Förenta staterna, 60608
- University of Illinois at Chicago
-
Evanston, Illinois, Förenta staterna, 60201
- North Shore University HealthSystem/Evanston Hospital
-
Peoria, Illinois, Förenta staterna, 61637
- Saint Francis Medical Center
-
-
Iowa
-
Waterloo, Iowa, Förenta staterna, 50701
- Cedar Valley Clinical Research
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- Kansas University Medical Center
-
-
Kentucky
-
Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky
-
-
Maine
-
Scarborough, Maine, Förenta staterna, 04074
- Maine Health Institute of Research
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Förenta staterna, 02111
- Tufts Medical Center
-
Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Med. Ctr.
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
-
-
Missouri
-
St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
-
New Hampshire
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87102
- University of New Mexico Health Sciences Center
-
-
New York
-
Brooklyn, New York, Förenta staterna, 11220
- NYU Langone Health/Brooklyn Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27514
- University of North Carolina Hospital
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
-
-
Oregon
-
Portland, Oregon, Förenta staterna, 97239-3098
- Oregon Health and Science University
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh
-
-
South Dakota
-
Sioux Falls, South Dakota, Förenta staterna, 57108
- Avera McKennan Hospital & University Health Center
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75235
- Southwest Family Medicine Associates
-
Houston, Texas, Förenta staterna, 77030
- Houston Methodist Hospital
-
Houston, Texas, Förenta staterna, 77030
- University of Texas Health Science Center at Houston
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah
-
-
Vermont
-
Colchester, Vermont, Förenta staterna, 05446
- Vermont Lung Center, University of Vermont
-
-
West Virginia
-
Huntington, West Virginia, Förenta staterna, 25701
- University Physicians and Surgeons, Inc dba Marshall Health
-
Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia Clinical and Translational Science Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
≥ 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.
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total Number of Participants Enrolled in Each Appendix
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Gary M Felker, MD, Duke Clinical Research Institute
- Studiestol: Barry Make, MD, National Jewish Health
- Studiestol: Lucinda Bateman, MD, Bateman Horne Center
- Studiestol: Janna Friedly, MD, MPH, University of Washington
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Post-infektionssjukdomar
- Covid-19
- Patologiska processer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Luftvägsinfektioner
- Infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- Patologiska tillstånd, tecken och symtom
- Beteende
- Postakut covid-19 syndrom
- Motorisk aktivitet
- Socioekonomiska faktorer
- Befolkningsegenskaper
- Utbildningsstatus
Andra studie-ID-nummer
- Pro00112409
- OT2HL156812 (U.S.S. NIH-anslag/kontrakt)
- NHLBI Grant to RTI (Annat bidrag/finansieringsnummer: RTI subcontracting with DCRI)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The summary of the results will be shared on the study website: https://recovercovid.org/
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .