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
Verified date | February 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
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 |
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