Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia

NCT04459676 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: ANG3777-ALI-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

COVID-19; Pneumonia

Keywords

COVID-19; Acute Lung Injury; Acute Respiratory Distress Syndrome; Pneumonia; Respiratory Failure; AKI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Standard of Care + Placebo

PLACEBO COMPARATOR

Standard of Care + Placebo

Drug: Standard Of Care (SOC) + Placebo

Interventions

Standard of Care (SOC) + ANG-3777 DRUG

Standard of Care (SOC) + ANG-3777

Also known as: BB3, Hepatocyte growth factor mimetic

ANG-3777 + SOC

Standard Of Care (SOC) + Placebo DRUG

Standard Of Care + Placebo

Standard of Care + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Score 4, only those with FiO2 \> 40%
• Score 5 (Non-invasive ventilation or high-flow oxygen)
• 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

You may not qualify if:

• 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.
• Patient is pregnant or breast-feeding.
• Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from the time of screening.
• 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.
• Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) \> 3x upper limit of normal (ULN) and/or total bilirubin \> 2xULN at baseline
• Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®)
• Patients participating in any other clinical trial with an investigational drug product or procedure
• Recipients of solid organ and/or hematopoietic cell transplantation
• 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

Sponsors & Collaborators

• Angion Biomedica Corp: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (10)

Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica

Belo Horizonte, Minas Gerais, Brazil

Location

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Pontifícia Universidade Catolica de Campinas

Campinas, São Paulo, Brazil

Location

UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu

Botucatu, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)

Ribeirão Preto, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Location

Hospital Heliópolis-SP

São Paulo, Brazil

Location

Hospital Vila Nova Star

São Paulo, Brazil

Location

Irmandade da Santa Casa de Misericórdia de São

São Paulo, Brazil

Location

Santa Casa de Misericordia de Sao Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Acute Lung Injury; Respiratory Distress Syndrome; Respiratory Insufficiency

Interventions

Standard of Care; terevalefim

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John Neylan, MD

  Angion Biomedica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 7, 2020
• Study Start: July 31, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

BR (10)