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

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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Withdrawn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

Trial design

0 participants in 2 patient groups, including a placebo group

Angiotensin (1-7)
Experimental group
Description:
Participants receive treatment for 7 days.
Treatment:
Drug: Angiotensin-(1-7)
Placebo
Placebo Comparator group
Description:
Participants receive treatment for 7 days.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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