NCT06404073Completed
RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))
RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 3 May 2024
- Start date
- 17 Jul 2024
- Primary completion date
- 18 Aug 2025
- Lead sponsor
- Duke University
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06404073
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 17 Jul 2024 to the primary completion date, 18 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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:
- Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
- Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND Answer of YES to either item 7 or 8 on Screening mDSQ-PEM, and response of \>14 h in item 9.
- 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:
- Inability to attend in-person screening visit or participate in weekly visits (in-person \[≥ 1\] and remote)
- Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All sites listed under NCT06404047 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.