Ramipril for the Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Ramipril 2.5 MG Oral Capsule; Placebo oral capsule
Intervention description: Include description or ramipril from protocol; Placebo
Intervention MeSH terms: Ramipril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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