Ramipril for the Treatment of COVID-19

Overview

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.

Full Title of Study: “A Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy of Ramipril to Prevent ICU Admission, Need for Mechanical Ventilation or Death in Persons With COVID-19”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2021

Interventions

  • Drug: Ramipril 2.5 MG Oral Capsule
    • Include description or ramipril from protocol
  • Drug: Placebo oral capsule
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Ramipril 2.5mg orally daily
    • Total 2.5 mg Ramipril per day once a day orally for 14 days Intervention: Ramipril
  • Placebo Comparator: Placebo
    • Placebo in the form of a capsule, taken orally for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • Composite of mortality or need for ICU admission or ventilator use
    • Time Frame: 14 days
    • The major primary outcome to be evaluated is improving a composite outcome of mortality or need for ICU admission or ventilator use within a 14-day window.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rohit Loomba, Professor of Medicine – University of California, San Diego
  • Overall Contact(s)
    • Len Lazaro, 858-822-3708, llazaro@health.ucsd.edu

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