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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04459676
Other study ID # ANG3777-ALI-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 31, 2020
Est. completion date April 30, 2021

Study information

Verified date April 2021
Source Angion Biomedica Corp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient is a male or nonpregnant female 18 years of age or older. 2. 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. 3. Patient has pneumonia confirmed by chest imaging. 4. Patient has moderate to severe disease based on the WHO disease severity scale assessment at the time of randomization defined as: - Score 4, only those with FiO2 > 40% - Score 5 (Non-invasive ventilation or high-flow oxygen) 5. Patient has ability to provide informed consent signed by study patient or legally acceptable representative. 6. Patient has willingness and ability to comply with study-related procedures/assessments Exclusion Criteria: 1. Has an active malignancy or history of solid or hematological malignancies within 5 years prior to enrollment in the study. Patients who had basal or squamous cell carcinoma-in-situ of the skin that was diagnosed > 2 years prior to the study enrollment and not currently being treated are eligible for study enrollment. 2. Patient is pregnant or breast-feeding. 3. Patient, in the opinion of the investigator, is unlikely to survive for =48 hours from the time of screening. 4. Patient has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study. 5. Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3x upper limit of normal (ULN) and/or total bilirubin > 2xULN at baseline 6. Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®) 7. Patients participating in any other clinical trial with an investigational drug product or procedure 8. Recipients of solid organ and/or hematopoietic cell transplantation 9. Patient is known to have End Stage Renal Disease (ESRD) and was being treated with maintenance hemodialysis or peritoneal dialysis prior to the current hospitalization. Note: Patients who initiated RRT due to Acute Kidney Injury during their current hospitalization will be eligible for the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Standard of Care (SOC) + ANG-3777
Standard of Care (SOC) + ANG-3777
Standard Of Care (SOC) + Placebo
Standard Of Care + Placebo

Locations

Country Name City State
Brazil Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica Belo Horizonte Minas Gerais
Brazil UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu Botucatu
Brazil Pontifícia Universidade Catolica de Campinas Campinas Sao Paulo
Brazil Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP) Ribeirão Preto
Brazil Hospital Vila Nova Star Sao Paulo
Brazil Irmandade da Santa Casa de Misericórdia de São Sao Paulo
Brazil Hospital Alemao Oswaldo Cruz São Paulo
Brazil Hospital Heliópolis-SP São Paulo
Brazil Santa Casa de Misericordia de Sao Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Angion Biomedica Corp CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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