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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04570501
• Other study ID #: 58189
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: February 2022
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Angiotensin-(1-7)
Ang (1-7) administered by continuous intravenous (IV) infusion
• Placebo
Placebo (normal saline) administered by continuous intravenous (IV) infusion

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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