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Cardiac Medication
Ivabradine for Post-COVID Syndrome (COVIVA Trial)
Phase 4
Recruiting
Led By David L Saunders, MD, MPH
Research Sponsored by Uniformed Services University of the Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
Age 18-80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
COVIVA Trial Summary
This trial aims to understand Long-Haul COVID, identify risk factors & outcomes, and find ways to improve recovery & enhance health. It also looks to improve knowledge of LHC and its associated cardiovascular & autonomic consequences.
Who is the study for?
This trial is for adults aged 18-80 who've had COVID-19, with or without long-term symptoms (LHC), and now have POTS—a condition causing rapid heartbeat when standing. Participants must be willing to use effective contraception if applicable, not have certain heart conditions or severe liver issues, and can't be on specific medications.Check my eligibility
What is being tested?
The study tests Ivabradine's effectiveness in reducing tachycardia (rapid heartbeat) among those with POTS after COVID-19. It aims to understand the proportion of patients with POTS symptoms, characterize risk factors/outcomes related to LHC, and explore cellular/molecular differences.See study design
What are the potential side effects?
Ivabradine may cause side effects such as a slower heart rate than normal (bradycardia), high blood pressure during changes in posture, vision disturbances like increased brightness in the field of vision, and potential fetal harm if taken during pregnancy.
COVIVA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had COVID-19 confirmed by a test.
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I am between 18 and 80 years old.
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I do not have long-term COVID-19 symptoms.
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I have had COVID-19 symptoms for more than 12 weeks.
COVIVA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in standing heart rate following 3 months treatment.
COVIVA Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Long Haul COVIDActive Control1 Intervention
Persistent signs and/or symptoms >12 weeks post Covid-infection N = 200 evaluable subjects.
Group II: Post COVID without LHCActive Control1 Intervention
No persistent signs and/or symptoms >12 weeks N = 50 evaluable subjects.
Group III: Ivabradine RCT ArmsPlacebo Group1 Intervention
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
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Who is running the clinical trial?
Uniformed Services University of the Health SciencesLead Sponsor
116 Previous Clinical Trials
90,730 Total Patients Enrolled
David L Saunders, MD, MPHPrincipal InvestigatorUniformed Services University of the Health Sciences
Mark C Haigney, MD, FAHAStudy ChairUniformed Services University of the Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver problems.I have a very slow heartbeat.I am not allergic to the study drug.I am currently experiencing a sudden worsening of my heart failure.I have been diagnosed with a fast heartbeat originating above the heart's ventricles.Your heart rate is only maintained by a pacemaker.You have experienced significant low blood pressure when changing positions during a medical test.I agree to use effective birth control or practice abstinence during the study.I have or don't have LHC and may have POTS based on my heart rate and blood pressure.I am currently taking certain medications.You have expressed thoughts of harming yourself recently.I cannot take pills due to issues with my digestive system.I have had COVID-19 confirmed by a test.You don't have a recorded history of infection, but tests show that you have had an infection in the past.You have specific heart rhythm problems, unless you have a pacemaker that works well.Your heart beats less than 60 times per minute when you are at rest.I have atrial fibrillation.I am between 18 and 80 years old.You have had a confirmed case of COVID-19 and shared the medical record with the study team.I do not have long-term COVID-19 symptoms.I am willing to join a specific drug trial if I meet the requirements.I have had COVID-19 symptoms for more than 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Ivabradine RCT Arms
- Group 2: Long Haul COVID
- Group 3: Post COVID without LHC
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age of 45 years and above an acceptable requirement for participants in this research?
"In accordance with this trial's predetermined regulations, potential participants must be between 18-80 years old to qualify for enrollment."
Answered by AI
Is the research team currently recruiting participants for this clinical trial?
"This trial, first posted on the 2nd of May 2023, is actively enrolling participants. The study's details were last updated on March 21st 2023 according to clinicaltrials.gov."
Answered by AI
Will I qualify for enrollment in this medical trial?
"This medical study seeks 250 patients, aged 18-80 years old suffering from postural orthostatic tachycardia syndrome. Additionally, eligible applicants must be willing to enroll in the related randomized controlled trial of ivabradine if they meet its criteria."
Answered by AI
How many research participants have been enlisted in this investigation?
"Affirmative. The particulars on clinicaltrials.gov verify that this research is presently enrolling participants, with the original posting date being May 2nd 2023 and the most recent update taking place on March 21st 2023. 250 test subjects are needed to be recruited from a single site."
Answered by AI
What adverse effects may arise from this form of therapy?
"There is substantial clinical data affirming this treatment's safety, thus it receives a score of 3."
Answered by AI
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