NCT06305806CompletedPhase 2
RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)
RECOVER-AUTONOMIC (Ivabradine): Randomized Trial of the Effect of Ivabradine Versus Placebo on Long COVID Symptoms
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 181 (actual)
- First submitted
- 4 Mar 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 13 Oct 2025
- Lead sponsor
- Kanecia Obie Zimmerman
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06305806
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 181
- From 11 Mar 2024 to the primary completion date, 13 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)
- Additional Appendix B (Ivabradine Sub-study) Level Inclusion Criteria:
- 1\. Abnormal active standing test defined as presence of orthostatic tachycardia and experiencing orthostatic symptoms. Orthostatic tachycardia defined as: Increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension (decline of ≥ 20 mmHg of systolic or ≥ 10 mmHg of diastolic blood pressure after 3 minutes of standing) OR History of documented increase of 30 bpm or more from an active stand test or tilt table test without orthostatic hypotension in the past 1 year AND standing HR above 100 bpm at the Screening/Baseline visit active stand test.
- Exclusions Criteria:
- See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)
- Additional Appendix B (Ivabradine Sub-study) Level Exclusion Criteria:
- A person of child-bearing potential who is not taking effective contraception
- Use of midodrine, pyridostigmine, fludrocortisone, and guanfacine will be excluded unless participant is on a stable dose (\>4 weeks). Participants on stable doses will be allowed to continue the medication throughout the study
- Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties
- Severe hepatic impairment
- Use of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidineUse of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine
- Concomitant use of digoxin or Paxlovid
- Known history of atrial fibrillation or significant cardiac arrhythmia not due to reversible cause
- Participants who are pacemaker dependent
- Patients with hypokalemia (serum K+\<3.5 mEq/L)
- Patients taking potassium-depleting diuretics, unless potassium level is normal at the baseline CMP, in which case participants may continue taking it during the study.
- A history of congenital or acquired long QT syndrome, with or without torsade de pointes
- Patients with high degree AV block such as Type 2 AV block, Mobitz II
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All sites listed under NCT06305780 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.