Evaluating Ivabradine for treating autonomic dysfunction in Long COVID
RECOVER-AUTONOMIC (Ivabradine): Randomized Trial of the Effect of Ivabradine Versus Placebo on Long COVID Symptoms
This study is testing if Ivabradine can help people with Long COVID who are dealing with symptoms of autonomic dysfunction feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06305806 on ClinicalTrials.gov |
What this trial studies
This platform protocol study aims to assess various interventions, including Ivabradine, for treating autonomic dysfunction symptoms in individuals suffering from Long COVID. It is a multi-center, randomized, controlled trial that will evaluate both pharmacologic and non-pharmacologic therapies. The study hypothesizes that some symptoms may be immune-mediated, and thus, immunotherapy and other treatments could lead to symptom improvement. The flexible design allows for the integration of additional interventions as needed.
Who should consider this trial
Good fit: Ideal candidates include individuals with Long COVID who exhibit orthostatic tachycardia and related symptoms.
Not a fit: Patients who are pregnant or not using effective contraception, or those on certain excluded medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients experiencing debilitating autonomic dysfunction due to Long COVID.
How similar studies have performed: Other studies have explored treatments for Long COVID symptoms, but this specific approach using Ivabradine is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Inclusion Criteria: 1. Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms 2. COMPASS-31 Score \> 25 and not enrolled in the IVIG appendix 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: 1. A person of child-bearing potential who is not taking effective contraception 2. Use of the following medications: clonidine, tizanidine, amphetamines, and serotonin and norepinephrine reuptake inhibitors (SNRIs) with the exception of modafinil 3. Use of beta-blockers (any formulation), calcium channel blockers, 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. 4. Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties 5. Lactating and breast-feeding women 6. Severe hepatic impairment 7. Use of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine 8. Concomitant use of digoxin 9. Participants who are pacemaker dependent 10. Patients with hypokalemia (serum K+\<3.5 mEq/L) 11. Patients taking potassium-depleting diuretics 12. A history of congenital or acquired long QT syndrome, with or without torsade de pointes 13. Patients with high degree AV block such as Mobitz II
Where this trial is running
Durham, North Carolina
- All sites listed under NCT06305780 — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Orshi Moy
- Email: recoverresearch@duke.edu
- Phone: 919-668-8060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.