COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04366050

Len Lazaro

llazaro@health.ucsd.edu

2020-04-28

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

- 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

2

University of California, San Diego

18

None

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

560

Composite of mortality or need for ICU admission or ventilator use

None

Phase 2

[{"arm_notes": "", "treatment_id": 1061, "treatment_name": "Ramipril", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]