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| Name | Class |
|---|---|
| CTI Clinical Trial and Consulting Services | OTHER |
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To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the severity and progression of pulmonary and renal dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANG-3777 + SOC | Active Comparator | ANG-3777 Administered IV for 30 min and SOC Repeat within 24 hours after previous dosing for a total of 4 days |
|
| Standard of Care + Placebo | Placebo Comparator | Standard of Care + Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care (SOC) + ANG-3777 | Drug | Standard of Care (SOC) + ANG-3777 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28 | From the time of randomization until (Day 1) until death or until Day28, whichever comes first |
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Inclusion Criteria:
Patient is a male or nonpregnant female 18 years of age or older.
Patient has a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample during the current hospital admission.
Patient has pneumonia confirmed by chest imaging.
Patient has moderate to severe disease based on the WHO disease severity scale assessment at the time of randomization defined as:
Patient has ability to provide informed consent signed by study patient or legally acceptable representative.
Patient has willingness and ability to comply with study-related procedures/assessments
Exclusion Criteria:
Note: Patients who initiated RRT due to Acute Kidney Injury during their current hospitalization will be eligible for the study
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| Name | Affiliation | Role |
|---|---|---|
| John Neylan, MD | Angion Biomedica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica | Belo Horizonte | Minas Gerais | Brazil | |||
| Santa Casa de Misericórdia de Porto Alegre |
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| Standard Of Care (SOC) + Placebo | Drug | Standard Of Care + Placebo |
|
| Porto Alegre |
| Rio Grande do Sul |
| Brazil |
| Pontifícia Universidade Catolica de Campinas | Campinas | São Paulo | Brazil |
| UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu | Botucatu | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP) | Ribeirão Preto | Brazil |
| Hospital Alemao Oswaldo Cruz | São Paulo | Brazil |
| Hospital Heliópolis-SP | São Paulo | Brazil |
| Hospital Vila Nova Star | São Paulo | Brazil |
| Irmandade da Santa Casa de Misericórdia de São | São Paulo | Brazil |
| Santa Casa de Misericordia de Sao Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C000711731 | terevalefim |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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