RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)

Description

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.

Conditions

Long COVID, Long Covid19, Long Covid-19

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

RECOVER-AUTONOMIC (Ivabradine): Randomized Trial of the Effect of Ivabradine Versus Placebo on Long COVID Symptoms

RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)

Condition
Long COVID
Intervention / Treatment

-

Contacts and Locations

Durham

All sites listed under NCT06305780, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kanecia Obie Zimmerman,

Christopher Grainger, MD, STUDY_CHAIR, Duke Clinical Research Institute

Cyndya Shibao, MD, STUDY_CHAIR, Vanderbilt University Medical Center

Peter Novak, MD, STUDY_CHAIR, Harvard

Pam Taub, MD, STUDY_CHAIR, University of California, San Diego

Tae Chung, MD, STUDY_CHAIR, Johns Hopkins University

Study Record Dates

2026-03