CClinicalTrials.gg
WithdrawnNCT04570501Updated Mar 3, 2022

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

A Phase 1/2 interventional study of Angiotensin-(1-7) and Placebo in Covid19, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Stanford University · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Discontinuation of drug candidates
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Covid19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Angiotensin (1-7)

    Participants receive treatment for 7 days.

    Drug: Angiotensin-(1-7)

  • Placebo comparator
    Placebo

    Participants receive treatment for 7 days.

    Drug: Placebo

Interventions

  • DrugAngiotensin-(1-7)

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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). 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

    Time frame: Up to 29 days

Secondary outcomes

  1. Incidence of mortality at Day 29

    Time frame: 29 days

  2. Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose

    Time frame: Up to 29 days

  3. Number of participants requiring mechanical ventilation or ECMO, or dying, through Day 29

    Time frame: Up to 29 days

  4. COVID-19 disease severity scale score on Day 8

    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

    Time frame: Day 8

  5. COVID-19 disease severity scale score on Day 15

    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

    Time frame: Day 15

  6. COVID-19 disease severity scale score on Day 22

    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

    Time frame: Day 22

  7. COVID-19 disease severity scale score on Day 29

    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

    Time frame: Day 29

07

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04570501
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
Sep 30, 2020
Start date
Feb 2022 (estimated)
Primary completion
Aug 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
Mar 3, 2022

Study contacts

Kevin V Grimes, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion