This is a platform protocol designed to be flexible so that it is suitable for a range ofinterventions and settings within diverse health care systems and community settings withincorporation into clinical COVID-19 management programs and treatment plans if resultsachieve key study outcomes.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platformtrial evaluating interventions to address and improve exercise intolerance andpost-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2Infection (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.
Behavioral: Structured Pacing
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.
Other: Usual Care
Participants in this group will receive basic education about PEM with a weekly call by
site study staff for support and communication.
• 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
All sites listed under NCT06404047
Durham, North Carolina, United States
Nilda Itchon-Ramos
919-668-8060
recoverresearch@duke.edu
Barrie Harper
recoverresearch@duke.edu