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

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Angiotensin-(1-7)
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Angiotensin (1-7)

Placebo

Arm Description

Participants receive treatment for 7 days.

Participants receive treatment for 7 days.

Outcomes

Primary Outcome Measures

Time to recovery
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). = Death; = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; = Hospitalized and requiring supplemental oxygen; = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; = Not hospitalized, limitation on activities and/or requiring home oxygen; = Not hospitalized, no limitation on activities

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2020
Last Updated
February 15, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04570501
Brief Title
Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Discontinuation of drug candidates
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angiotensin (1-7)
Arm Type
Experimental
Arm Description
Participants receive treatment for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive treatment for 7 days.
Intervention Type
Drug
Intervention Name(s)
Angiotensin-(1-7)
Intervention Description
Ang (1-7) administered by continuous intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (normal saline) administered by continuous intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Time to recovery
Description
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). = Death; = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; = Hospitalized and requiring supplemental oxygen; = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; = Not hospitalized, limitation on activities and/or requiring home oxygen; = Not hospitalized, no limitation on activities
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
Incidence of mortality at Day 29
Time Frame
29 days
Title
Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
Time Frame
Up to 29 days
Title
Number of participants requiring mechanical ventilation or ECMO, or dying, through Day 29
Time Frame
Up to 29 days
Title
COVID-19 disease severity scale score on Day 8
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 8
Title
COVID-19 disease severity scale score on Day 15
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 15
Title
COVID-19 disease severity scale score on Day 22
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 22
Title
COVID-19 disease severity scale score on Day 29
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin V Grimes, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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