Table 2.
Inclusion Criteria | Exclusion Criteria |
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Age ≥ 18 years Currently hospitalized or with a visit to an emergency department or urgent care 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 ≤7 days before randomization OR Clinical presentation consistent with SARS-CoV-2 infection (fever or cough or shortness of breath) with positive IgM serology |
Participation in any other clinical trial of an experimental treatment for COVID-19 (compassionate use of hydroxychloroquine, chloroquine, azithromycin or emergency use authorization of remdesivir outside of a clinical trial is allowed) Requiring mechanical ventilation at screening Requiring ICU care at admission NSAID use within 12 h of randomization or requiring continued NSAID use during this triala Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) Estimated GFR < 40 mL/minb 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 an ACE inhibitor 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 |
If a participant took an NSAID prior to presentation they could still be screened for the study and randomized 12 h after the dose of NSAID with counseling to avoid further NSAID use.
GFR of 40 mL/min is the threshold for dose reduction of ramipril.