Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort (COVIVA)
Long Haul COVID, Postural Orthostatic Tachycardia Syndrome
About this trial
This is an interventional treatment trial for Long Haul COVID
Eligibility Criteria
Inclusion Criteria:
- Age 18-80
- History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
- Meets criteria for 'long-haul' COVID-19 with symptoms >12 weeks following acute illness
- Able and willing to provide informed consent and participate for study duration
- Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met
- Access to a primary healthcare provider and proof of health insurance
Inclusion Criteria for non-LHC Cohort
- Age 18-80
- History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
- Does not meet criteria for 'long-haul' COVID-19
- Able and willing to provide informed consent and participate for study duration
- Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met
- Access to a primary healthcare provider and proof of health insurance
Inclusion Criteria for POTS RCT:
Age 18-80; Meets criteria for 'long-haul' COVID-19
- Documented history of COVID-19 infection made available to study team 1914
- Lack of documented history, but evidence of infection from sensitive antibody tests
- Able and willing to provide informed consent and participate for study duration
- Volunteers with or without LHC combined with POTS based on an increase in comparing the supine heart rate to standing heart rate >20 beats per minute with a drop in systolic blood pressure less than 20 mm Hg or a drop in diastolic blood pressure less than 10 mm Hg will be included, OR additionally, volunteers with or without LHC and a 24-hour mean heart rate of 90 beats per minute or more (in sinus rhythm) will be diagnosed with IST and be included.
- For females of childbearing age - willing to use a highly effective form of contraceptive with <1% failure rate or practice abstinence for the duration of the study
Exclusion Criteria:
- Resting heart rate <60 bpm
- Atrial fibrillation
- Supraventricular tachycardia
Allergic reaction or known contraindications to study drug
- Acute decompensated heart failure
- Clinically significant hypotension, defined as a drop in systolic BP >20 mmHg or drop in diastolic >10 mmHg during orthostatic vital signs testing.
- Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present
- Clinically significant bradycardia
- Severe hepatic impairment
- Pacemaker dependence (heart rate maintained exclusively by the pacemaker)
- Concomitant use of cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
- Pregnant/lactating females
- Impaired gastrointestinal absorption that would preclude oral drug administration
Taking any of the following without discontinuation in consultation with the volunteer's healthcare provider and a one-week washout period:
- ivabradine
- beta-blockers
- calcium- channel blockers
- cholinesterase inhibitors (pyridostigmine),
- vasoconstrictors (midodrine, octreotide, droxidopa, stimulants)
- sympatholytics (clonidine, methyldopa)
- blood volume enhancers (fludrocortisone, desmopressin, salt supplementation)
- oral ketoconazole (contraindicated)
Acute suicidality identified at screening
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Sites / Locations
- Uniformed Services UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
No Intervention
Placebo Comparator
Long Haul COVID
Post COVID without LHC
Ivabradine RCT Arms
Persistent signs and/or symptoms >12 weeks post Covid-infection N = 200 evaluable subjects.
No persistent signs and/or symptoms >12 weeks N = 50 evaluable subjects.
If POTS or IST is present for participants within either of these cohorts, then they will be assigned to one of two arms of the Ivabradine RCT [2:1 treatment:control]. RCT Arms: at least 36 evaluable subjects will be enrolled to two arms in a 2:1 ratio. More may be enrolled, depending on the number from the overall COVID-19 cohort who qualify. IVA (Ivabradine) - at least 24 evaluable subjects Placebo - at least 12 evaluable subjects