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Platform for treating autonomic dysfunction in Long COVID patients

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

PHASE2 · Duke University · NCT06305780

This study is testing different treatments to see if they can help people with Long COVID who are dealing with autonomic dysfunction symptoms like heart problems and dizziness.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment380 (estimated)
Ages18 Years and up
SexAll
SponsorDuke University (other)
Drugs / interventionsimmunotherapy
Locations50 sites (Opelika, Alabama and 49 other locations)
Trial IDNCT06305780 on ClinicalTrials.gov

What this trial studies

This platform protocol is designed to evaluate various interventions for treating autonomic dysfunction symptoms in individuals suffering from Long COVID. It is a multi-center, multi-arm, randomized, controlled trial that will assess both pharmacologic and non-pharmacologic therapies. The study aims to determine if immune-mediated therapies can improve symptoms such as cardiovascular complications and postural orthostatic tachycardia syndrome (POTS). Interventions will be added as needed, allowing for flexibility in treatment approaches.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have had a previous SARS-CoV-2 infection and are experiencing autonomic dysfunction symptoms.

Not a fit: Patients who do not have a history of SARS-CoV-2 infection or those under 18 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients suffering from debilitating symptoms of Long COVID.

How similar studies have performed: Other studies have explored treatments for Long COVID symptoms, but this platform approach is relatively novel and aims to integrate multiple interventions.

Eligibility criteria

Show full inclusion / exclusion 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 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.
   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.

   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.
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

Exclusion Criteria:

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

Where this trial is running

Opelika, Alabama and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Long COVID, Long Covid19, Long Covid-19, PASC, POTS

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.