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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

PARACOR-19 Trial Summary

This trial will test if a heart medication can help people who have had COVID-19. It will look at markers of heart damage, structure, and function.

Eligible Conditions

Coronavirus

PARACOR-19 Trial 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

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

PARACOR-19 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,197,311 Total Patients Enrolled

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,027 Total Patients Enrolled

Stephen J Greene, MDPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are allowed to participate in this research project at one time?

"Yes, the latest information available on clinicaltrials.gov indicates that this trial is still recruiting patients. This particular study was first posted 8/6/2021 and was updated as recently as 9/26/2022. They are currently searching for 50 individuals at 1 location to participate."

Answered by AI

Are people still able to sign up for this clinical trial?

"According to the latest information on clinicaltrials.gov, this research is currently looking for 50 participants at a single site. The listing was first posted on 8/6/2021 and edited most recently on 9/26/2022."

Answered by AI

For what purpose is Sacubitril / Valsartan Oral Tablet [Entresto] most often prescribed?

"The common heart condition known as left ventricular dysfunction is often treated with Sacubitril / Valsartan Oral Tablet [Entresto]. Additionally, this medication can be used to treat essential hypertension and prevent cardiovascular events."

Answered by AI

Are there any other scientific papers that mention Sacubitril / Valsartan Oral Tablet [Entresto]?

"At the moment, there are 39 different clinical trials studying Sacubitril / Valsartan Oral Tablet [Entresto]. Out of those active trials, 8 are in Phase 3. The majority of studies for Sacubitril / Valsartan Oral Tablet [Entresto] take place in Montreal, Quebec; however, there are a total of 812 locations running trials for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019

2021. "Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04883528.