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Angiotensin Receptor-Neprilysin Inhibitor

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
Awards & highlights

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in high-sensitivity troponin T
Change from baseline in soluble ST2
Secondary outcome measures
Change from baseline in C-reactive peptide
Change from baseline in EuroQOL-5 dimensions utility score
Change from baseline in EuroQOL-5 dimensions visual analog scale
+8 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, adminstered 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
2,874 Previous Clinical Trials
4,199,949 Total Patients Enrolled
Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,444 Total Patients Enrolled
Stephen J Greene, MDPrincipal InvestigatorDuke University
~10 spots leftby Sep 2025
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