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

NCT04570501 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 58189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

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

  Up to 29 days

Secondary Outcomes (7)

• 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 score on Day 15

  Day 15

Study Arms (2)

Angiotensin (1-7)

EXPERIMENTAL

Participants receive treatment for 7 days.

Drug: Angiotensin-(1-7)

Placebo

PLACEBO COMPARATOR

Participants receive treatment for 7 days.

Drug: Placebo

Interventions

Angiotensin-(1-7) DRUG

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

Angiotensin (1-7)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kevin V Grimes, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: September 30, 2020
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)