Ramipril for the Treatment of COVID-19

• Status: Recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, medical history, and symptom assessment, patients will receive either 2.5 mg/day of ramipril or placebo. Patients' symptoms and study endpoints will be monitored at regular intervals. After 14 days, patients will undergo a laboratory assessment and an end-of-treatment follow-up visit at day 28. The primary endpoints of successful therapy will be improved survival, reductions in ICU admissions, and/or reductions in use of mechanical ventilator support.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Pfizer
• Treatments: Ramipril

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Willing and able to provide written informed consent prior to performing study procedures

• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 5 days before randomization OR Clinical presentation consistent with COVID-19 infection (fever or cough or shortness of breath) with positive IgM serology

• Currently hospitalized or in an emergency department

• Peripheral capillary oxygen saturation (SpO2) ≥ 93% on room air at screening

Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment for COVID-19 (use of hydroxycholoroquine or compassionate use of choloroquine or azithromycin is allowed)

• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug/placebo dosing

• Requiring mechanical ventilation at screening

• Requiring ICU care at admission

• NSAID use within 12 hours of randomization or requiring continued NSAID use during this trial

• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)

• Estimated GFR < 40 mL/min

• History of serum creatinine ≥ 2 mg/dl in the previous 28 days

• Systolic BP < 100 mm hg or diastolic BP < 65 mm hg

• Hypersensitivity to ACEI

• History of angioedema

• Outpatient use of ACE inhibitor or Angiotensin II receptor blocker in the last 7 days

• History of renal artery stenosis

• Serum potassium ≥ 5.1 mEq/L

• Pregnancy or breastfeeding

• Use of aliskiren, amifostine, lithium, sacubitril within 7 days