This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
205
University of Florida Health Gainesville
Gainesville, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days
Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.
Time frame: 7 days
Daily Hypotensive Episodes
Outcome reported as the mean number of daily hypotensive episodes (MAP \< 65 mmHg) prompting intervention (indicated by a fluid bolus \>=500 mL) per participant in each arm.
Time frame: 10 days
Proportion of Participants Requiring Vasopressors for Hypotension
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Time frame: 10 days
Proportion of Participants Experiencing Acute Kidney Injury
Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.
Time frame: 10 days
Oxygen Saturation / Fractional Inhaled Oxygen (S/F)
Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The S/F ratio is unitless.
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Henry Ford Hospital
Detroit, Michigan, United States
M Health Fairview Ridges Hospital
Burnsville, Minnesota, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
North Memorial Health Hospital
Robbinsdale, Minnesota, United States
...and 3 more locations
Time frame: 7 days
28-Day Mortality
Outcome reported as the number of participants who have expired at 28 days post enrollment.
Time frame: 28 days
90-Day Mortality
Outcome reported as the number of participants who have expired at 90 days post enrollment.
Time frame: 90 days
ICU Admission
Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Time frame: 10 days
Number of Ventilator-Free Days
Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Time frame: 28 days
Number of Therapeutic Oxygen-Free Days
Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.
Time frame: 28 days
Number of Vasopressor-Free Days
Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.
Time frame: 10 days
Length of Hospital Stay
Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
Time frame: 90 days
Disease Severity Rating
Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Time frame: 28 days
Change in Viral Load by Nasopharyngeal Swab Day 15
Nasopharyngeal swabs will be collected at baseline and day 15. Viral load is measured as number of viral genetic copies per mL.
Time frame: 15 days