RECOVER-AUTONOMIC Platform Protocol

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.

Conditions

Long COVID, Long Covid19, Long Covid-19

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Study Overview

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Study Details

Study overview

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.

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

RECOVER-AUTONOMIC Platform Protocol

Condition
Long COVID
Intervention / Treatment

-

Contacts and Locations

Opelika

East Alabama Medical Center - Appendix A & B, Opelika, Alabama, United States, 36801

Phoenix

Center for Complex Neurology - Appendix A & B, Phoenix, Arizona, United States, 85006

Los Angeles

Cedars Sinai Medical Center - Appendix A & B, Los Angeles, California, United States, 90048

Aurora

University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B, Aurora, Colorado, United States, 80045

Washington

MedStar National Rehabilitation Hospital - Appendix B only, Washington, District of Columbia, United States, 20010

Gainesville

University of Florida Health - Appendix A & B, Gainesville, Florida, United States, 32610

Palmetto Bay

Innovation Clinical Trials Inc.- Appendix A & B, Palmetto Bay, Florida, United States, 33157

Chicago

Rush University Medical Center - Appendix A & B, Chicago, Illinois, United States, 60612

Evanston

NorthShore University HealthSystem - Evanston Hospital - Appendix B Only, Evanston, Illinois, United States, 60201

Iowa City

University of Iowa - Appendix A & B, Iowa City, Iowa, United States, 52242

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 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.
  • 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.
  • 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.
  • 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
  • 4. OHQ/OIQ, question 1 score \>2
  • 1. Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
  • 2. Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
  • 3. Known renal failure (eGFR \<20ml/1.73 m²)
  • 4. Known atrial fibrillation or significant cardiac arrhythmia
  • 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. 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. Existing uncontrolled hypertension
  • 8. History of significant hypercoagulability disorders
  • 9. Active or recent thrombosis

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-03