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Angiotensin Receptor-Neprilysin Inhibitor
Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019 (PARACOR-19 Trial)
Phase 1 & 2
Waitlist Available
Led By Stephen J Greene, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Summary
This trial is testing a heart medication called sacubitril/valsartan on people who have recovered from COVID-19. The goal is to see if it can help improve their heart health by making it easier for blood to flow and reducing stress on the heart. Sacubitril/valsartan has been shown to reduce the risk of cardiovascular death or heart failure hospitalization and improve symptoms in chronic heart failure with reduced ejection fraction.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in High-sensitivity Troponin T
Change From Baseline in Soluble ST2
Secondary study objectives
Change From Baseline in C-reactive Peptide (CRP)
Change From Baseline in CITP (C-terminal Telopeptide of Collagen Type I)
Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sacubitril/valsartanExperimental Treatment1 Intervention
Initial dose for patients randomized to sacubitril/valsartan (LCZ696) will be determined by the blood pressure at the time of randomization. Study treatment will be titrated to the next highest dose (dose level 2 or 3) based on blood pressure at the time of visit 2/titration visit. Dose adjustments are only allowed if indicated per protocol defined criteria and per investigator judgement of safety and tolerability.
Sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
Other Name: LCZ696
Group II: PlaceboPlacebo Group1 Intervention
Initial dose for patients randomized to sacubitril/valsartan matching placebo will be determined by the blood pressure at the time of randomization. Study treatment will be titrated to the next highest dose (dose level 2 or 3) based on blood pressure at the time of visit 2/titration visit. Dose adjustments are only allowed if indicated per protocol defined criteria and per investigator judgement of safety and tolerability.
Sacubitril/valsartan matching placebo with minimum dose matching the 24/26 mg dose, maximum dose matching the 97/103 mg dose, administered twice daily orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacubitril / Valsartan Oral Tablet [Entresto]
2021
Completed Phase 3
~250
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,916 Previous Clinical Trials
4,253,843 Total Patients Enrolled
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,407 Total Patients Enrolled
Stephen J Greene, MDPrincipal InvestigatorDuke University
G. Michael Felker, MD, MHSPrincipal InvestigatorDuke University