RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))
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.
Conditions:
🦠 Long COVID 🦠 Long Covid19 🦠 Long Covid-19
🗓️ Study Start (Actual) 21 July 2024
🗓️ Primary Completion (Estimated) October 2025
✅ Study Completion (Estimated) January 2026
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

  • • See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix
  • Inclusion Criteria:

    • 1. 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
    • 2. 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, or response of \>14 h in item 9.

    Exclusion Criteria:

    • 1. Inability to attend in-person screening visit or participate in weekly visits (in-person \[≥ 1\] and remote)
    • 2. Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 May 2024
  • First Submitted that Met QC Criteria 6 May 2024
  • First Posted 8 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified June 2024