- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570501
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
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).
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 58189
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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