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Ramipril for the Treatment of COVID-19

CompletedPhase 2

Sponsor: University of California, San Diego

Conditions: COVID-19

Interventions: Ramipril 2.5 MG Oral Capsule, Placebo oral capsule

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

La Jolla, California, United States