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

February 15, 2022 updated by: Stanford University

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Angiotensin (1-7)
Participants receive treatment for 7 days.
Ang (1-7) administered by continuous intravenous (IV) infusion
PLACEBO_COMPARATOR: Placebo
Participants receive treatment for 7 days.
Placebo (normal saline) administered by continuous intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: Up to 29 days

Time to recovery, defined as attaining a score of 6, 7, or 8 on the COVID-19 disease severity scale, an 8 point ordinal scale used in the NIH Adaptive COVID-19 Treatment Trial (ACTT; NCT04280705).

  1. = Death;
  2. = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
  3. = Hospitalized and on non-invasive ventilation or high-flow oxygen devices;
  4. = Hospitalized and requiring supplemental oxygen;
  5. = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise);
  6. = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care;
  7. = Not hospitalized, limitation on activities and/or requiring home oxygen;
  8. = Not hospitalized, no limitation on activities
Up to 29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 disease severity scale score on Day 8
Time Frame: Day 8
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Day 8
COVID-19 disease severity scale score on Day 15
Time Frame: Day 15
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Day 15
COVID-19 disease severity scale score on Day 22
Time Frame: Day 22
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Day 22
COVID-19 disease severity scale score on Day 29
Time Frame: Day 29
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Day 29
Incidence of mortality at Day 29
Time Frame: 29 days
29 days
Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
Time Frame: Up to 29 days
Up to 29 days
Number of participants requiring mechanical ventilation or ECMO, or dying, through Day 29
Time Frame: Up to 29 days
Up to 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (ACTUAL)

September 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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