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

• ClinicalTrials.gov Identifier: NCT04570501
• Recruitment Status: Not yet recruiting
• First Posted: September 30, 2020
• Last Update Posted: January 19, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

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 (Clinical Trial)
• Estimated Enrollment: 160 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
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: July 2021
• Estimated Study Completion Date: July 2021

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

Outcome Measures

Primary Outcome Measures :

1. 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).

   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

Secondary Outcome Measures :

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 [ Time Frame: Day 8 ]
   COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
5. 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).
6. 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).
7. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, California

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Kevin V Grimes, MD; Stanford University

More Information

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04570501
• Other Study ID Numbers: 58189
• First Posted: September 30, 2020
• Last Update Posted: January 19, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Angiotensin I (1-7); Antihypertensive Agents; Vasodilator Agents