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

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Withdrawn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