COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04883528

Stephen J Greene

Not reported

2021-05-12

Completed

RCT

Randomized

Parallel

Blind label

single-center

Long covid

inclusion criteria: patient with a history of laboratory proven-diagnosis of covid-19 who is 4-16 weeks from their last positive covid-19 test systolic blood pressure ≥100 mmhg at screening ≥18 years of age successful collection of baseline serum biomarkers successful completion of baseline eq-5d questionnaire successful completion of baseline cmr study (cmr sub-study only) high-sensitivity troponin t at or above the level of detection on screening labs presence of ≥1 of the following: age ≥60 history of atherosclerotic cardiovascular disease (ascvd), including myocardial infarction, coronary artery disease, ischemic stroke/transient ischemic attack, or peripheral artery disease diabetes mellitus (type 1 or type 2) body mass index ≥35 kg/m2 egfr 30-60 ml/min/1.73m2 history of atrial fibrillation/flutter

fever within the past 96 hours of >100.3 degrees fahrenheit actively receiving therapy with an angiotensin-converting enzyme inhibitor (acei), angiotensin ii receptor blocker (arb), aliskiren, or sacubitril/valsartan last known left ventricular ejection fraction of ≤40% egfr <30 ml/min/1.73m2 on screening labs, including patients on dialysis therapy serum potassium >5.0 meq/l on screening labs prior intolerance, allergy or angioedema to acei, arb, or sacubitril/valsartan pregnant or breast-feeding in women of childbearing age, unwillingness to use birth control for the duration of the study history of heart transplant or durable left ventricular assist device currently implanted permanent pacemaker, defibrillator, or other device that would preclude cmr testing (cmr sub-study only) currently participating in another trial of an investigational medication or device for covid-19. any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol

2

Duke University

18

100

United States

Patients recovered from covid

N/A

42

Change from baseline in high-sensitivity troponin T;Change from baseline in soluble ST2

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1699, "treatment_name": "Sacubitril+valsartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]