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Discontinuation of drug candidates
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiotensin (1-7) | Experimental | Participants receive treatment for 7 days. |
|
| Placebo | Placebo Comparator | Participants receive treatment for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin-(1-7) | Drug | Ang (1-7) administered by continuous intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin V Grimes, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C118790 | angiotensin I (1-7) |
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| Placebo | Drug | Placebo (normal saline) administered by continuous intravenous (IV) infusion |
|
| Up to 29 days |
| 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 |
| 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 |
| 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 |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |