Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019

Covid19 Clinical Trial

— PARACOR-19  

Official title:

Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883528
• Other study ID #: Pro00108314
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 6, 2021
• Est. completion date: June 13, 2023

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of sacubitril/valsartan versus placebo on markers of cardiac injury, structure, and function among patients who recovered from acute COVID-19 infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with a history of laboratory proven-diagnosis of COVID-19 who is 4-16 weeks from their last positive COVID-19 test

2. Systolic blood pressure =100 mmHg at screening

3. =18 years of age

4. Successful collection of baseline serum biomarkers

5. Successful completion of baseline EQ-5D questionnaire

6. Successful completion of baseline CMR study (CMR sub-study only)

7. High-sensitivity troponin T at or above the level of detection on screening labs

8. Presence of =1 of the following:

1. Age =60

2. History of atherosclerotic cardiovascular disease (ASCVD), including myocardial infarction, coronary artery disease, ischemic stroke/transient ischemic attack, or peripheral artery disease

3. Diabetes mellitus (Type 1 or Type 2)

4. Body mass index =35 kg/m2

5. eGFR 30-60 ml/min/1.73m2

6. History of atrial fibrillation/flutter

Exclusion Criteria:

1. Fever within the past 96 hours of >100.3 degrees Fahrenheit

2. Actively receiving therapy with an angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), aliskiren, or sacubitril/valsartan

3. Last known left ventricular ejection fraction of =40%

4. eGFR <30 ml/min/1.73m2 on screening labs, including patients on dialysis therapy

5. Serum potassium >5.0 mEq/L on screening labs

6. Prior intolerance, allergy or angioedema to ACEI, ARB, or sacubitril/valsartan

7. Pregnant or breast-feeding

8. In women of childbearing age, unwillingness to use birth control for the duration of the study

9. History of heart transplant or durable left ventricular assist device

10. Currently implanted permanent pacemaker, defibrillator, or other device that would preclude CMR testing (CMR sub-study only)

11. Currently participating in another trial of an investigational medication or device for COVID-19.

12. Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Sacubitril / Valsartan Oral Tablet [Entresto]
sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
• Placebo
sacubitril/valsartan matching placebo tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in high-sensitivity troponin T		Baseline, Week 12
Primary	Change from baseline in soluble ST2		Baseline, Week 12
Secondary	Change from baseline in C-reactive peptide		Baseline, Week 12
Secondary	Change from baseline in PINP		Baseline, Week 12
Secondary	Change from baseline in Galectin-3		Baseline, Week 12
Secondary	Change from baseline in NT-proBNP		Baseline, Week 12
Secondary	Change from baseline in GDF-15		Baseline, Week 12
Secondary	Change from baseline in interleukin-6		Baseline, Week 12
Secondary	Change from baseline in cardiac MRI measures		Baseline, Week 12
Secondary	Change from baseline in focal fibrosis by delayed-enhancement on cardiac MRI		Baseline, Week 12
Secondary	Change from baseline in focal fibrosis by percentage of left ventricular myocardial mass on cardiac MRI		Baseline, Week 12
Secondary	Change from baseline in EuroQOL-5 dimensions utility score		Baseline, Week 12
Secondary	Change from baseline in EuroQOL-5 dimensions visual analog scale		Baseline, Week 12