COMPLETED

RECOVER-AUTONOMIC Platform Protocol

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Conditions

Long COVIDLong Covid19Long Covid-19PASCPOTS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Official Title

RECOVER-AUTONOMIC: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Quick Facts

Study Start:2024-03-11
Study Completion:2025-07-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06305780

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 18 years of age at the time of enrollment
  2. 2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization12ɸ ɸ Enrollment of participants with suspected or probable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study Drug Appendix. Refer to the Manual of Procedures (MOP) for details.
  3. 1. 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.
  4. 2. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with 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. Presents 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.
  5. 3. Moderate, self-identified autonomic symptoms (defined as COMPASS-31 \>25) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
  6. 4. OHQ/OIQ, question 1 score \>2
  1. 1. Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
  2. 2. Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
  3. 3. Known renal failure (eGFR \<20ml/1.73 m²)
  4. 4. Known atrial fibrillation or significant cardiac arrhythmia
  5. 5. Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease, symptomatic ischemic coronary artery disease, revascularization for PAD/CAD within the past 6 months
  6. 6. Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina
  7. 7. Existing uncontrolled hypertension
  8. 8. History of significant hypercoagulability disorders
  9. 9. Active or recent thrombosis

Contacts and Locations

Principal Investigator

Christopher Granger, MD
STUDY_CHAIR
Duke Clinical Research Institute
Cyndya Shibao, MD
STUDY_CHAIR
Vanderbilt University Medical Center
Peter Novak, MD
STUDY_CHAIR
Harvard
Pam Taub, MD
STUDY_CHAIR
University of California, San Diego
Tae Chung, MD
STUDY_CHAIR
Johns Hopkins University

Study Locations (Sites)

East Alabama Medical Center - Appendix B Only
Opelika, Alabama, 36801
United States
Center for Complex Neurology - Appendix A & B
Phoenix, Arizona, 85006
United States
University of Arkansas for Medical Sciences - Appendix A & B
Little Rock, Arkansas, 72205
United States
University of California San Diego - Appendix B Only
La Jolla, California, 92307
United States
Cedars Sinai Medical Center - Appendix A & B
Los Angeles, California, 90048
United States
Stanford University - Appendix B Only
Stanford, California, 94305
United States
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B
Aurora, Colorado, 80045
United States
MedStar National Rehabilitation Hospital - Appendix B only
Washington, District of Columbia, 20010
United States
University of Florida Health - Appendix A & B
Gainesville, Florida, 32610
United States
Lakeland Regional Medical Center - Appendix A & B
Lakeland, Florida, 33805
United States
Innovation Clinical Trials Inc.- Appendix A & B
Palmetto Bay, Florida, 33157
United States
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B
Atlanta, Georgia, 30303
United States
Morehouse School of Medicine - Appendix A & B
Atlanta, Georgia, 30310
United States
Queens Medical Center - Appendix B Only
Honolulu, Hawaii, 96813
United States
Rush University Medical Center - Appendix B Only
Chicago, Illinois, 60612
United States
University of Illinois at Chicago - Appendix A & B
Chicago, Illinois, 60612
United States
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only
Evanston, Illinois, 60201
United States
University of Iowa - Appendix A & B
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center CTSU Fairway - Appendix A & B
Fairway, Kansas, 66205
United States
University of Kentucky Medical Center - Appendix A & B
Lexington, Kentucky, 40536
United States
University Medical Center New Orleans - Appendix A & B
New Orleans, Louisiana, 70112
United States
Johns Hopkins Hospital - Appendix A Only
Baltimore, Maryland, 21287
United States
Brigham and Women's Hospital - Appendix A Only
Boston, Massachusetts, 02115
United States
Henry Ford Hospital - Appendix A & B
Detroit, Michigan, 48202
United States
Mayo Clinic - Appendix A & B
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center - Appendix A & B
Jackson, Mississippi, 39216
United States
Washington University School of Medicine - Appendix B Only
Saint Louis, Missouri, 63110
United States
Montefiore Medical Center - Moses Campus - Appendix B
Bronx, New York, 10467
United States
University at Buffalo - Appendix A & B
Buffalo, New York, 14203
United States
St. Lawrence Health Medical Campus - Appendix A & B
Canton, New York, 13617
United States
Columbia University Irving Medical Center - Appendix A & B
New York, New York, 10032
United States
Stony Brook University Hospital - Appendix A & B
Stony Brook, New York, 11794
United States
Duke University Hospital - Appendix A & B
Durham, North Carolina, 27710
United States
East Carolina University - Appendix B Only
Greenville, North Carolina, 27834
United States
Cleveland Clinic - Appendix A & B
Cleveland, Ohio, 44195
United States
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University - Appendix A & B
Portland, Oregon, 97239
United States
Kent Hospital - Appendix A & B
Pawtucket, Rhode Island, 02860
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
National Neuromuscular Research Institute - Appendix A & B
Austin, Texas, 78759
United States
Southwest Family Medicine Associates - Appendix A & B
Dallas, Texas, 75235
United States
University of Texas Health Science Center at Houston
Houston, Texas, 78701
United States
University of Texas Health Science Center at San Antonio - Appendix A & B
San Antonio, Texas, 78229
United States
Bateman Horne Center - Appendix B Only
Salt Lake City, Utah, 84102
United States
Vermont Lung Center, University of Vermont - Appendix B Only
Burlington, Vermont, 05405
United States
University of Virginia Health System, University Hospital - Appendix A & B
Charlottesville, Virginia, 22908
United States
Sentara Norfolk General Hospital - Appendix A & B
Norfolk, Virginia, 23507
United States
Evergreen Hospital Medical Center - Appendix A & B
Kirkland, Washington, 98034
United States
Providence Medical Research Center - Appendix A & B
Spokane, Washington, 99204
United States
Marshall Health - University Physicians and Surgeons - Appendix A & B
Huntington, West Virginia, 25701
United States

Collaborators and Investigators

Sponsor: Kanecia Obie Zimmerman

  • Christopher Granger, MD, STUDY_CHAIR, Duke Clinical Research Institute
  • Cyndya Shibao, MD, STUDY_CHAIR, Vanderbilt University Medical Center
  • Peter Novak, MD, STUDY_CHAIR, Harvard
  • Pam Taub, MD, STUDY_CHAIR, University of California, San Diego
  • Tae Chung, MD, STUDY_CHAIR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11
Study Completion Date2025-07-09

Study Record Updates

Study Start Date2024-03-11
Study Completion Date2025-07-09

Terms related to this study

Keywords Provided by Researchers

  • PASC
  • POTS

Additional Relevant MeSH Terms

  • Long COVID
  • Long Covid19
  • Long Covid-19