Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT04366050
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04366050
Study Brief:
Protocol Section:
NCT04366050