The primary objective is to evaluate the safety and efficacy of intravenous (IV) infusion of Ang (1-7) compared to placebo with respect to time to recovery, disease severity, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and mortality in patients with COVID 19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Ang (1-7) administered by continuous intravenous (IV) infusion
Placebo (normal saline) administered by continuous intravenous (IV) infusion
Stanford University
Stanford, California, United States
Time to recovery
Time to recovery, defined as attaining a score of 6, 7, or 8 on the COVID-19 disease severity scale, an 8 point ordinal scale used in the NIH Adaptive COVID-19 Treatment Trial (ACTT; NCT04280705). 1. = Death; 2. = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; 4. = Hospitalized and requiring supplemental oxygen; 5. = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); 6. = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; 7. = Not hospitalized, limitation on activities and/or requiring home oxygen; 8. = Not hospitalized, no limitation on activities
Time frame: Up to 29 days
Incidence of mortality at Day 29
Time frame: 29 days
Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
Time frame: Up to 29 days
Number of participants requiring mechanical ventilation or ECMO, or dying, through Day 29
Time frame: Up to 29 days
COVID-19 disease severity scale score on Day 8
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time frame: Day 8
COVID-19 disease severity scale score on Day 15
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time frame: Day 15
COVID-19 disease severity scale score on Day 22
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COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time frame: Day 22
COVID-19 disease severity scale score on Day 29
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time frame: Day 29