Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients

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.

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