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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL156812 | U.S. NIH Grant/Contract | View source | |
| NHLBI Grant to RTI | Other Grant/Funding Number | RTI subcontracting with DCRI |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Pacing (PEM) | Experimental | 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. |
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| Usual Care | Other | Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Pacing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM) | Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. | Baseline, week 12 (End Of Intervention (EOI) |
| Change in severity of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM) | Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. | Baseline, week 12 (EOI) |
| Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM) | Baseline, week 12 (EOI) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PASC symptoms, as measured by the PASC Symptom Questionnaire | The PASC Symptom Questionnaire is a 33-question survey for self-reporting multiple PASC-related symptoms across multiple systems. | Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| Change in PASC symptoms, as measured by the PROMIS-Cog Questionnaire |
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• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix
Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria:
or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of >14h in item 9.
Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary M Felker, MD | Duke Clinical Research Institute | Study Chair |
| Barry Make, MD | National Jewish Health | Study Chair |
| Lucinda Bateman, MD | Bateman Horne Center | Study Chair |
| Janna Friedly, MD, MPH | University of Washington | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All sites listed under NCT06404047 | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42282195 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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The summary of the results will be shared on the study website: https://recovercovid.org/
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2025 | May 19, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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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.
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| Usual Care | Other | Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
|
The PROMIS Short Form v.2.0 - Cognitive Function 8a (PROMIS-Cog) is the PROMIS Short Form to assess cognitive function and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. |
| Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| Change in quality of life, as measured by the PROMIS-29+2 | The PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). | Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| Change in quality of life, as measured by the EQ-5D 5L | The EQ-5D is a standardized measure of health status. | Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| Change in physical activity, as measured by Actigraphy | Actigraphy will be measured by Fitbit. | Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| Change in physical activity, as measured by the PROMIS SF-Physical Function (PROMIS-PF) | The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. | Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| Change in orthostatic hypotension, as measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ) | The Orthostatic Hypotension Questionnaire (OHQ) is a measure of orthostatic intolerance. The modified OHQ (mOHQ) measure used in this study includes a total of ten items related to daily activities and symptoms. | Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS) |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |