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

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

ArmDescriptionAssigned Intervention
Experimental
Angiotensin (1-7)
Participants receive treatment for 7 days.
  • Drug: Angiotensin-(1-7)
    Ang (1-7) administered by continuous intravenous (IV) infusion
Placebo Comparator
Placebo
Participants receive treatment for 7 days.
  • Drug: Placebo
    Placebo (normal saline) administered by continuous intravenous (IV) infusion

Recruiting Locations

More Details

NCT ID
NCT04570501
Status
Withdrawn
Sponsor
Stanford University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.