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

NCT ID: NCT04570501

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Angiotensin (1-7)

Participants receive treatment for 7 days.

Group Type EXPERIMENTAL

Angiotensin-(1-7)

Intervention Type DRUG

Ang (1-7) administered by continuous intravenous (IV) infusion

Placebo

Participants receive treatment for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (normal saline) administered by continuous intravenous (IV) infusion

Interventions

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Angiotensin-(1-7)

Ang (1-7) administered by continuous intravenous (IV) infusion

Intervention Type DRUG

Placebo

Placebo (normal saline) administered by continuous intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin V Grimes, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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58189

Identifier Type: -

Identifier Source: org_study_id

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