Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Angiotensin (1-7) |
Participants receive treatment for 7 days. |
|
Placebo Comparator Placebo |
Participants receive treatment for 7 days. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04570501
- Status
- Withdrawn
- Sponsor
- Stanford University