Covid19
Conditions
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.
Interventions
Ang (1-7) administered by continuous intravenous (IV) infusion
DRUGPlacebo
Placebo (normal saline) administered by continuous intravenous (IV) infusion
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (range; 1-8, higher scores correspond to better health state). |
| Incidence of mortality at Day 29 | 29 days | — |
| COVID-19 disease severity scale score on Day 22 | Day 22 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
| COVID-19 disease severity scale score on Day 29 | Day 29 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
| COVID-19 disease severity scale score on Day 15 | Day 15 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
Countries
United States
Outcome results
None listed