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

Stanford University

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Covid19

Treatments

Drug: Placebo

Drug: Angiotensin-(1-7)

Study type

Interventional

Funder types

Other

Identifiers

NCT04570501

58189

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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