RECOVER-ENERGIZE Platform Protocol

Description

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

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Study Overview

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Study Details

Study overview

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.

RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

RECOVER-ENERGIZE Platform Protocol

Condition
Long COVID
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35205

Phoenix

Banner University Medical Center Phoenix, Phoenix, Arizona, United States, 85006

Tucson

Banner University Medical Center Tucson, Tucson, Arizona, United States, 85719

Stanford

Stanford University, Stanford, California, United States, 94035

Torrance

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, United States, 90509

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale - New Haven Hospital, New Haven, Connecticut, United States, 06520-8017

Jacksonville

University of Florida College of Medicine Jacksonville, Jacksonville, Florida, United States, 32209

Atlanta

Grady Memorial Hospital (Emory), Atlanta, Georgia, United States, 30303

Decatur

Emory Hope Clinic, Decatur, Georgia, United States, 30030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ≥ 18 years of age at the time of enrollment
  • 2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization\*
  • * Suspected\* or probable SARS-CoV-2 infection will only be allowed if it occurred before May 1, 2021, and will be limited to no more than 10% of the study population. Otherwise, confirmed cases are required.
  • 3. Self-reported limitation to physical activity due to the presence of symptoms such as fatigue, shortness of breath, and/or PEM following a SARS-CoV-2 infection, that has persisted for at least 12 weeks and is present at the time of consent.
  • 4. Willing, able, and agree to provide informed consent, complete questionnaires and outcome assessments, and participate in the study, including assigned intervention or control and study visits whether remote, hybrid, or in-person.
  • 1. Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent.
  • 2. Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), not related to SARS-CoV-2 infection.
  • 3. Current or recent use (within the last 14 days) of a formal program utilizing one or more of the current study intervention(s) or similar intervention(s) to treat the underlying condition, unless a washout period is permitted per Appendices.
  • 4. Participation in another interventional clinical trial.
  • 5. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Gary M Felker, MD, STUDY_CHAIR, Duke Clinical Research Institute

Barry Make, MD, STUDY_CHAIR, National Jewish Health

Lucinda Bateman, MD, STUDY_CHAIR, Bateman Horne Center

Janna Friedly, MD, MPH, STUDY_CHAIR, University of Washington

Study Record Dates

2026-01