Status:
COMPLETED
Ramipril for the Treatment of COVID-19
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 eit...
Detailed Description
Ramipril has not been studied in SARS-CoV-2 infected patients. In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, med...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04366050
Start Date
May 11 2020
End Date
May 12 2021
Last Update
September 28 2023
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92093