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

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ClinicalTrials.gov Identifier: NCT04570501
Recruitment Status : Not yet recruiting
First Posted : September 30, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

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

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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 : December 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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




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).



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570501


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kevin V Grimes, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04570501    
Other Study ID Numbers: 58189
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Angiotensin I (1-7)
Antihypertensive Agents
Vasodilator Agents