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Long COVIDNCT06404047

RECOVER-ENERGIZE Platform Protocol

A study testing Personalized Cardiopulmonary Rehabilitation, Structured Pacing and Education in people with Long COVID and Long Covid19, run by Duke University at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID, Long Covid19, Long Covid-19
What is being tested?
Personalized Cardiopulmonary Rehabilitation, Structured Pacing and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
42 sitesUnited States
Study dates
17 Jul 2024to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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 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:
Show all 11Show fewer
  • 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 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.

Who cannot join

  • 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.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

  • Grady Memorial Hospital (Emory)

    Atlanta, Georgia, 30303

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Med. Ctr.

    Boston, Massachusetts, 02215

  • NYU Langone Health/Brooklyn Hospital

    Brooklyn, New York, 11220

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27514

  • University of Illinois at Chicago

    Chicago, Illinois, 60608

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Vermont Lung Center, University of Vermont

    Colchester, Vermont, 05446

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Emory Hope Clinic

    Decatur, Georgia, 30030

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Shore University HealthSystem/Evanston Hospital

    Evanston, Illinois, 60201

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University Physicians and Surgeons, Inc dba Marshall Health

    Huntington, West Virginia, 25701

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida, 32209

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Innovation Clinical Trials Inc.

    Miami, Florida, 33144

  • Valencia Medical and Research Center

    Miami, Florida, 33165

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia, 26506

  • Yale - New Haven Hospital

    New Haven, Connecticut, 06520-8017

  • Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84132

  • Maine Health Institute of Research

    Scarborough, Maine, 04074

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota, 57108

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94035

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90509

  • Banner University Medical Center Tucson

    Tucson, Arizona, 85719

  • Cedar Valley Clinical Research

    Waterloo, Iowa, 50701

Other trials in United States

About this study

Official title: RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (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.

Read the 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.

Being tested
Personalized Cardiopulmonary Rehabilitation, Structured Pacing, Education, Usual Care
Keywords
PASC, Exercise, PEM (post exertional malaise)
Medical subject headings
Post-Acute COVID-19 Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Cardiopulmonary RehabilitationBehavioural

    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 PacingBehavioural

    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.

  • EducationOther

    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 CareOther

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

Study groups in NCT06404047
Study groupRoleWhat they receive
Experimental: Appendix A - Cardiopulmonary Rehabilitation (Exercise Intolerance)ExperimentalAppendix 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.
Receives: Behavioral: Personalized Cardiopulmonary Rehabilitation; Other: Education
Experimental: Appendix B - Structured Pacing (PEM)ExperimentalAppendix 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.
Receives: Behavioral: Structured Pacing; Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of participants enrolled in each Appendix

    Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start17 Jul 2024
  3. Primary completion30 Oct 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404047
Sponsor's protocol ID
Pro00112409
Other IDs
OT2HL156812, NHLBI Grant to RTI
Status last verified
Oct 2025
First submitted
3 May 2024
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The summary of the results will be shared on the study website: https://recovercovid.org/

Publications

  • Friedly J, Bateman L, Berdan LG, Casaburi R, Erdmann N, Felker GM, Itchon-Ramos N, Keteyian SJ, MacIntyre N, O'Brien L, Reist C, Rossiter HB, Silverstein A, Taylor E, Pike Welch H, Yanez ND, Zimmerman KO, Make B. Rationale and Design of RECOVER-ENERGIZE: A Platform Clinical Trial of Interventions for Exercise Intolerance With and Without Post-exertional Malaise in Long COVID. medRxiv [Preprint]. 2026 Jun 3:2026.06.02.26354455. doi: 10.64898/2026.06.02.26354455.

    PubMed 42282195

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Cardiopulmonary Rehabilitation, Structured Pacing and Education in people with Long COVID and Long Covid19, run by Duke University at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of participants enrolled in each Appendix (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06404047, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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