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

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Angiotensin I (1-7)

Criteria

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