RECOVER-ENERGIZE Platform Protocol

Launched by DUKE UNIVERSITY · May 6, 2024

Keywords

ClinConnect Summary

The RECOVER-ENERGIZE trial is studying different ways to help people who have long-lasting symptoms after recovering from COVID-19, known as Long COVID. Many individuals experience problems like extreme tiredness, difficulty exercising, and feeling worse after physical activity. This trial aims to find out if certain treatments can improve people's ability to exercise, their daily life activities, and overall quality of life.

To participate in this study, you need to be at least 18 years old and have had a confirmed or suspected case of COVID-19 at some point. You should also be experiencing ongoing issues with physical activity, like fatigue or shortness of breath, that have lasted for at least 12 weeks. If you join, you'll be asked to complete questionnaires, attend study visits, and may receive one of the treatments being tested or a control treatment. This research is currently looking for participants, and it offers a chance to contribute to finding better options for those affected by Long COVID.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Suspected case of SARS-CoV-2 infection - Three options, A through C:
• • A. A person who meets the clinical OR epidemiological criteria. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization; or C. With no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
• Probable case of SARS-CoV-2 infection:
• • A. A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.
• Confirmed case of SARS-CoV-2 infection - Two options, A and B:
• • A. A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Meeting clinical criteria AND/OR epidemiological criteria (See suspected case A above for criteria). With a positive professional use or self-test SARS- CoV-2 Antigen-Rapid Diagnostic Test.
• • 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.
• Exclusion Criteria:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 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.