Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
Rohit Loomba (ucsd)
Photo of Rohit Loomba
Rohit Loomba

Description

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.

Official Title

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

Keywords

COVID-19 Ramipril Ramipril 2.5 MG Oral Capsule Ramipril 2.5mg orally daily

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, San Diego
    La Jolla California 92093 United States

Lead Scientist at UC Health

  • Rohit Loomba (ucsd)
    Adjunct Professor, Family Medicine and Public Health. Authored (or co-authored) 430 research publications.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
Links
Related Info
ID
NCT04366050
Phase
Phase 2
Study Type
Interventional
Last Updated