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.
Drug: Angiotensin-(1-7)
Ang (1-7) administered by continuous intravenous (IV) infusion
Drug: Placebo
Placebo (normal saline) administered by continuous intravenous (IV) infusion
Inclusion Criteria:
- Signs and symptoms suggestive of COVID-19 infection including cough or dyspnea
- Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction
(PCR) test ≤7 days before randomization
- Currently hospitalized or in an emergency department with planned hospitalization
- Peripheral capillary oxygen saturation (SpO2) ≤93% on room air or partial pressure of
oxygen (PaO2)/fraction of inspired oxygen (FiO2) <300 at Screening
Exclusion Criteria:
- Simultaneous participation in any other clinical study incompatible with this one
- Treatment with an antibody immunotherapy that is not standard of care for COVID-19
within 4 weeks of Screening
- Requirement for mechanical ventilation or ECMO at Screening
- Hypotension at Screening, defined as supine BP <95 mm Hg systolic or <55 mm Hg
diastolic
- Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
- Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) <30
mL/min
- Any known immune deficiency
- Pregnancy or breastfeeding
Stanford University
Stanford, California, United States
Kevin V Grimes, MD, Principal Investigator
Stanford University