Platform for improving exercise tolerance in Long COVID patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This platform protocol is designed to evaluate various interventions aimed at improving exercise intolerance and post-exertional malaise (PEM) in patients suffering from Long COVID. It is a multi-center, randomized, controlled trial that allows for flexibility in interventions, which may include personalized cardiopulmonary rehabilitation, structured pacing, education, and usual care. Participants will be screened for eligibility and then randomized to either an intervention group or a control group based on specific criteria. The goal is to enhance exercise capacity, daily activity tolerance, and overall quality of life for individuals affected by Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Banner University Medical Center Phoenix
  Phoenix, Arizona, United States Recruiting
• Banner University Medical Center Tucson
  Tucson, Arizona, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Nilda Itchon-Ramos
• Email: recoverresearch@duke.edu
• Phone: 919-668-8060

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long COVID relief through learning mindfulness

  This study will try an 8-week online recorded mindfulness program to see if it reduces stress and Long COVID symptoms in adults who continue their usual care.

  Recruiting Columbia University · New York, New York · NCT07140094

• Anktiva for treating Long COVID symptoms

  This will test whether Anktiva helps adults aged 18–69 who had confirmed COVID-19 and now have persistent or worsened Long COVID symptoms.

  Recruiting Phase 2 ImmunityBio, Inc. · El Segundo, California · NCT07123727

• Rehabilitation program to reduce fatigue after COVID-19

  This study is testing a new rehabilitation program called COVIDEx to see if it can help people with Long COVID feel less tired compared to standard care.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT06156176

• Transcranial Direct Current Stimulation for Long COVID with Headaches and Chronic Pain

  This study tests whether applying mild brain stimulation (tDCS) can help people with long COVID who have headaches, migraines, and ongoing pain.

  Recruiting at 2 sites Fundación Universidad Católica de Valencia San Vicente Mártir · Paiporta, Valencia and 1 other locations · NCT05780450

• A study using wearable devices to manage Long COVID symptoms

  This study is testing if using wearable devices can help people with Long COVID manage their symptoms and improve their quality of life.

  Recruiting Scripps Translational Science Institute · La Jolla, California · NCT05741112

• Whole-body Cryotherapy for Fatigue in ME/CFS, Fibromyalgia, Long COVID

  This study tests whether brief, repeated exposure to extreme cold can help reduce fatigue and related symptoms in adults with ME/CFS, fibromyalgia, or Long COVID compared to healthy controls.

  Recruiting Oxford Brookes University · Oxford, Oxon · NCT07874217

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.