CompletedPhase 2

RECOVER-AUTONOMIC Platform Protocol

United States381 participantsStarted 2024-03-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ≥ 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.
✓. 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.
✓. 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

Exclusion criteria

What they're measuring

Total number of participants enrolled in each Appendix

Timeframe: Baseline to End of Intervention (IVIG 9 months, Ivabradine 3 months)

Trial details

NCT IDNCT06305780

SponsorKanecia Obie Zimmerman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-09

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