Sacubitril / Valsartan Oral Tablet [Entresto] for Coronavirus (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

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 more

Trial 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

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