Clinical trial NCT06404073: RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))
Official title: RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long COVID
Long Covid19
Long Covid-19
Keywords: PASC
Exercise
PEM (post exertional malaise)
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-05-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

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.

Eligibility criteria: • 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:

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, 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:

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

Primary outcomes:
measure: Change in frequency of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
timeFrame: Baseline, week 12 (End Of Intervention (EOI)), month 6 (End of Study (EOS))
measure: Change in severity of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
timeFrame: Baseline, week 12 (EOI), month 6 (EOS)
measure: Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)
timeFrame: Baseline, week 12 (EOI), month 6 (EOS)
Secondary outcomes:
measure: Change in PASC symptoms, as measured by the PASC Symptom Questionnaire
timeFrame: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
measure: Change in PASC symptoms, as measured by the PROMIS-Cog Questionnaire
timeFrame: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
measure: Change in quality of life, as measured by the PROMIS-29+2
timeFrame: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
measure: Change in quality of life, as measured by the EQ-5D 5L
timeFrame: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
measure: Change in physical activity, as measured by Actigraphy
timeFrame: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
measure: Change in physical activity, as measured by the PROMIS SF-Physical Function (PROMIS-PF)
timeFrame: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
measure: Change in orthostatic hypotension, as measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)
timeFrame: Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Other outcomes:
Locations:
city: Durham
country: United States
facility: All sites listed under NCT06404047
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Gary M Felker, MD
role: STUDY_CHAIR
affiliation: National Jewish Health
name: Barry Make, MD
role: STUDY_CHAIR
affiliation: Bateman Horne Center
name: Lucinda Bateman, MD
role: STUDY_CHAIR
affiliation: University of Washington
name: Janna Friedly, MD, MPH
role: STUDY_CHAIR
References: