RECOVER-AUTONOMIC Platform Protocol

Completed · Phase 2 · Has a placebo group

Conditions studied: Long COVID, Long Covid19, Long Covid-19

In brief

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.

Key facts

Study ID

NCT06305780

Run by

Kanecia Obie Zimmerman

People needed

381

Starts

2024-03-11

Expected to finish

2025-07-09

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age at the time of enrollment
• 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.
• Suspected case of SARS-CoV-2 infection - Three options, A through C:
• A. 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. 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.
• Probable case of SARS-CoV-2 infection, defined as 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 through 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 suspect case A). With a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
• Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >20) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
• OHQ/OIQ, question 1 score >2

You may not qualify if…

• Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
• Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
• Known renal failure (eGFR <20ml/1.73 m²)
• Known atrial fibrillation or significant cardiac arrhythmia
• Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease
• Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina
• Existing uncontrolled hypertension
• Inability to comply with the protocol
• Any condition that the investigator believes makes it inappropriate to treat with study intervention, including severe debility.
• History of POTS or significant dysautonomia before COVID-19 index infection
• Enrolled in another clinical trial or another study intervention appendix in this platform protocol * Patients who are a part of observational studies (e.g. imaging) may be included in this trial. Participants may enroll in another interventional trial or re-enroll in this trial for a different study intervention appendix 30 days after end of study (Follow-up visit).

Where it is running

• East Alabama Medical Center - Appendix B Only — Opelika, Alabama, United States
• Center for Complex Neurology - Appendix A & B — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences - Appendix A & B — Little Rock, Arkansas, United States
• University of California San Diego - Appendix B Only — La Jolla, California, United States
• Cedars Sinai Medical Center - Appendix A & B — Los Angeles, California, United States
• Stanford University - Appendix B Only — Stanford, California, United States
• University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B — Aurora, Colorado, United States
• MedStar National Rehabilitation Hospital - Appendix B only — Washington D.C., District of Columbia, United States
• University of Florida Health - Appendix A & B — Gainesville, Florida, United States
• Lakeland Regional Medical Center - Appendix A & B — Lakeland, Florida, United States
• Innovation Clinical Trials Inc.- Appendix A & B — Palmetto Bay, Florida, United States
• Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B — Atlanta, Georgia, United States
• Morehouse School of Medicine - Appendix A & B — Atlanta, Georgia, United States
• Queens Medical Center - Appendix B Only — Honolulu, Hawaii, United States
• Rush University Medical Center - Appendix B Only — Chicago, Illinois, United States
• University of Illinois at Chicago - Appendix A & B — Chicago, Illinois, United States
• NorthShore University HealthSystem - Evanston Hospital - Appendix B Only — Evanston, Illinois, United States
• University of Iowa - Appendix A & B — Iowa City, Iowa, United States
• University of Kansas Medical Center CTSU Fairway - Appendix A & B — Fairway, Kansas, United States
• University of Kentucky Medical Center - Appendix A & B — Lexington, Kentucky, United States
• University Medical Center New Orleans - Appendix A & B — New Orleans, Louisiana, United States
• Johns Hopkins Hospital - Appendix A Only — Baltimore, Maryland, United States
• Brigham and Women's Hospital - Appendix A Only — Boston, Massachusetts, United States
• Henry Ford Hospital - Appendix A & B — Detroit, Michigan, United States
• Mayo Clinic - Appendix A & B — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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