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

Sponsor

Stanford University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04570501

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Angiotensin-(1-7) Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Angiotensin (1-7) Participants receive treatment for 7 days.	Drug: Angiotensin-(1-7) Ang (1-7) administered by continuous intravenous (IV) infusion
Placebo Comparator: Placebo Participants receive treatment for 7 days.	Drug: Placebo Placebo (normal saline) administered by continuous intravenous (IV) infusion

Arm

Intervention/Treatment

Experimental: Angiotensin (1-7)

Participants receive treatment for 7 days.

Drug: Angiotensin-(1-7)

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

Placebo Comparator: Placebo

Participants receive treatment for 7 days.

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Kevin V Grimes, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT04570501

Other Study ID Numbers:

58189

First Posted:

Sep 30, 2020

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Angiotensin I (1-7)

Study Results

No Results Posted as of Mar 3, 2022