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.
Drug: Ramipril 2.5 MG Oral Capsule
Include description or ramipril from protocol
Other Name: Ramipril
Drug: Placebo oral capsule
Placebo
Other Name: Placebo
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
University of California, San Diego
La Jolla, California, United States
Investigator: Len Lazaro
Contact: 858-822-3708
llazaro@health.ucsd.edu
Len Lazaro
858-822-3708
llazaro@health.ucsd.edu
Archana Bhatt
858-822-2661
abhatt@health.ucsd.edu